[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anatomic-stage-iii-breast-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anatomic-stage-iii-breast-cancer-ajcc-v8":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,49,0,25,[9,44,71,104,222,247,269,290,322,340,362,382,400,426,448,471,491,510,531,598,625,647,667,688,707],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100520577","adding-an-immunotherapy-drug-medi4736-durvalumab-to-the-usual-chemotherapy-treatment-paclitaxel-cyclophosphamide-and-doxorubicin-for-stage-ii-iii-breast-cancer-100520577",false,"NCT06058377","Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer","Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for Adults With MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive \u002F Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer","Inclusion Criteria:\n\n* STEP 1: REGISTRATION (SCREENING): Participants must have histologically confirmed estrogen receptor (ER) positive and\u002For progesterone receptor (PR) positive (hormone receptor positive) and HER2 negative breast cancer, as per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines\n\n  * NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP guidelines that do not receive HER2 targeted therapy are eligible\n* STEP 1: REGISTRATION (SCREENING): Participants must have clinical stage II or III breast cancer\n\n  * NOTE: Participants with inflammatory breast cancer are eligible\n  * NOTE: Participants with occult (i.e. undetectable) primary breast cancer with axillary nodal involvement are not eligible, as MammaPrint testing has not been validated on tissue obtained from an axillary lymph node\n* STEP 1: REGISTRATION (SCREENING): Participants must not have metastatic disease (i.e., must be clinically M0 or Mx) Systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network (NCCN) and ASCO guidelines\n* STEP 1: REGISTRATION (SCREENING): Participants must not have locally recurrent breast cancer\n* STEP 1: REGISTRATION (SCREENING): Participants with multifocal disease in the same breast or synchronous bilateral primary tumors are eligible, however, all tumors that are biopsied must be hormone receptor positive and HER2 negative per ASCO CAP guidelines and at least one of the tumors must be MammaPrint High-2. MammaPrint can be performed sequentially on biopsies as it is sufficient to have MammaPrint High 2 status on at least one of the lesions\n\n  * NOTE: Biopsy of multiple lesions in the same breast is not required if the clinical presentation is consistent with a single disease process that is multifocal in nature. However, if there is clinical suspicion of two distinct primary breast malignancies, additional biopsies should be pursued\n* STEP 1: REGISTRATION (SCREENING): Participants must have either adequate tissue available to submit on-study or a prior known MammaPrint Index Score that is MP2 status\n\n  * Submitting tissue for on-study MammaPrint testing:\n\n    * Participants must have a minimum of ten, unstained formalin-fixed paraffin-embedded (FFPE) slides (4-5 micron thickness) available from initial tumor biopsy for MammaPrint assessment\n\n      * NOTE: Participants must agree to have this tissue submitted to Agendia for MammaPrint Index Scoring and to have subsequent results disclosed to Southwest Oncology Group (SWOG) Cancer Research Network OR\n  * Submitting prior known MammaPrint Index Score:\n\n    * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy\n\n      * NOTE: Participants must agree to have their commercial MammaPrint Index Score disclosed to SWOG Cancer Research Network\n      * NOTE: Participants with prior known MammaPrint result that is not MP2 status should not be enrolled to either step of this study\n      * NOTE: Participants enrolling with known MP2 status (i.e. MP already obtained as routine care) must only sign the treatment informed consent form. Screening consent is not required when MP2 status is known prior to study enrollment\n* STEP 1: REGISTRATION (SCREENING): Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy\n* STEP 1: REGISTRATION (SCREENING): Participants must be \\>= 18 years old at the time of registration\n* STEP 1: REGISTRATION (SCREENING): Participants must have body weight \\> 30 kg\n* STEP 1: REGISTRATION (SCREENING): Participants must have Zubrod Performance Status of 0-2\n* STEP 1: REGISTRATION (SCREENING): Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* STEP 1: REGISTRATION (SCREENING): Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\n* STEP 1: REGISTRATION (SCREENING): NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n* STEP 2: RANDOMIZATION: Participants must have met all eligibility criteria for Step 1 Registration\n* STEP 2: RANDOMIZATION: Participants must have MammaPrint High Risk 2 result\n\n  * For participants submitting tissue for on-study MammaPrint testing:\n\n    * Participants must be registered to Step 2: Randomization within 84 calendar days (12 weeks) after receiving an MP2 status from the MammaPrint Index score. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) from initial tumor biopsy OR\n  * Submitting commercial MammaPrint Index Score:\n\n    * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy\n\n      * NOTE: Participants without a MammaPrint High-Risk 2 score must not be registered to Step 2 Randomization\n* STEP 2: RANDOMIZATION: Participants must not have received live vaccines within 28 days prior to study Step 2: Randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines and coronavirus disease 2019 (COVID-19) vaccines are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed\n* STEP 2: RANDOMIZATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study\n* STEP 2: RANDOMIZATION: Participant must have Zubrod Performance Status of 0-2\n* STEP 2: RANDOMIZATION: Participants must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis within two years prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants must not have active autoimmune disease that has required systemic treatment in the past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) prior to Step 2: Randomization. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\n* STEP 2: RANDOMIZATION: Participant must have a complete medical history and physical exam within 28 days prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Leukocytes \\>= 3 x 10\\^3\u002FuL (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Absolute neutrophil count \\>= 1.5 x 10\\^3\u002FuL (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Platelets \\>= 100 x 10\\^3\u002FuL (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Total bilirubin =\\\u003C institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 × institutional ULN (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Participants must have a calculated creatinine clearance \\>= 50 mL\u002Fmin using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* STEP 2: RANDOMIZATION: Participants must not have uncontrolled diabetes defined as hemoglobin A1c of 9.0% or greater, within 28 days prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants with history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have an undetectable viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained while on suppressive therapy within 6 months prior to Step 2: Randomization, if indicated\n* STEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization, if indicated\n* STEP 2: RANDOMIZATION: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process and must have a negative pregnancy test at screening. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy\n* STEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\n* STEP 2: RANDOMIZATION: Participants who can complete questionnaires in English, or Spanish must be offered the opportunity to participate in the Quality of Life study\n* STEP 2: RANDOMIZATION: NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* STEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines","ALL","18 Years",{"count":20,"type":21},3680,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.",[27,28,29,30],"Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","HER2-Negative Breast Carcinoma","Hormone Receptor-Positive Breast Carcinoma","RECRUITING","2026-08-19",{"date":34,"type":35},"2026-08-20","ACTUAL",{"date":37,"type":35},"2023-11-27",{"date":39,"type":21},"2032-05-31",{"name":41,"class":42},"National Cancer Institute (NCI)","NIH",553,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100607681","phase-2-imlunestrant-and-abemaciclib-for-the-treatment-of-estrogen-receptor-positive-breast-cancer-in-patients-with-minimal-residual-disease-miri-trial-100607681","NCT07191717","Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial","Phase II Minimal Residual Disease Study of Selective Estrogen Receptor Degrader Imlunestrant With Cyclin-Dependent Kinase (CDK) 4\u002F6 Inhibitor Abemaciclib in Patients With ER+ Breast Cancer (MIRI)","Inclusion Criteria:\n\n* Participants must have localized ER+ (≥ 10% on surgical pathology), HER2 negative, any grade, invasive breast cancer. Pathological stage (from time of surgery, including patients who received neoadjuvant therapy) I - III by American Joint Committee on Cancer (AJCC) 8th edition staging\n\n  * Note: Invasive breast cancer must be ER+ in ≥ 10% of the cells and HER2 negative (immunohistochemistry \\[IHC\\] 0 or 1+ and\u002For fluorescence in situ hybridization \\[FISH\\] negative with a ratio \\\u003C 2) by American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines. For Immunohistochemistry (IHC) 2+, the tumor must be FISH negative with a ratio \\\u003C 2. ER, progesterone receptor (PR) and HER2 measurements should be performed according to institutional (local) guidelines, in a Clinical Laboratory Improvement Act (CLIA)-approved setting\n* Detectable ctDNA in a CLIA-certified lab (separate pre-screening consent available) within the past six months. Participants must have no clinical or radiographic evidence of recurrence as determined by the treating investigator\n* Confirmation of adequate archival tissue (either initial biopsy or surgical specimen) (15-20 unstained slides cut at 5 µm or 1 block) required before study entry. If adequate surgical tissue is available, this is preferred. Otherwise tissue from diagnostic biopsy is acceptable. If adequate tissue not available, principal investigator (PI) approval is required prior to study entry\n* No prior history of other malignancies within past 5 years (besides breast cancer as per inclusion #1). Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin. No concurrent malignancy or other serious medical condition as deemed by the investigator\n* Participants may or may not have received (neo)adjuvant chemotherapy and\u002For biological therapy at the time of screening, with no more than grade 1 residual toxicity (except ≤ grade 2 neuropathy or ≤ grade 2 alopecia)\n* Participants may or may not have received adjuvant radiotherapy, with no more than grade 1 residual toxicity\n* Pre- and postmenopausal women and men are eligible. Premenopausal women must have a negative serum pregnancy test at time of screening\n\n  * Pregnancy testing does not need to be pursued in female patients who are:\n\n    * Age ≥ 60 years; OR\n    * Age \\\u003C 60 with intact uterus AND amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range\n    * OR status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n* Must be ≥ 18 years of age\n* History of CDK 4\u002F6 inhibitor is permitted provided the last dose was more than 6 months ago (from consent date)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky ≥ 70%)\n* Patients must currently be on endocrine therapy in the adjuvant setting and must have received (neo) adjuvant endocrine therapy for at least 24 months (cumulative duration)\n* Ability to understand and the willingness to sign a written informed consent document. Patient must sign the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements\n* Participants must currently be receiving adjuvant endocrine therapy and have been on adjuvant endocrine therapy for at least 2 years. Adjuvant endocrine therapy can be either tamoxifen or aromatase inhibitor (AI), i.e prior use of any AI, including letrozole, anastrozole or exemestane, or tamoxifen is allowed. Concurrent gonadotrophin releasing hormone (GNRH) agonist is required with AI in pre - and\u002For peri-menopausal patients and men\n* Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL\n* Platelets ≥ 100 × 10\\^9\u002FL\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Serum creatinine \\\u003C 1.5 mg\u002FdL OR creatinine clearance ≥ 50 mL\u002Fmin\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5 x institutional upper limit of normal (ULN)\n* Total bilirubin \\\u003C institutional 1.5 times ULN; or total bilirubin ≤ 3.0 x institutional ULN. Patients with Gilbert's Syndrome with a total bilirubin ≤ 2.0 times ULN and direct bilirubin within normal limits are permitted\n* The patient is able to swallow oral medications\n\nExclusion Criteria:\n\n* Participants with metastatic disease (including contralateral axillary lymph nodes) or inflammatory breast cancer. Of note, if a patient had locally advanced breast cancer leading to inflammation, this would not exclude the patient on the grounds of inflammatory carcinoma\n* Participants who have had CDK 4\u002F6 inhibitor therapy within the past 6 months. Use of prior CDK 4\u002F6 inhibitor with last dose more than 6 months ago is permitted\n* Participants who are receiving any other anti-cancer investigational agents. Participation in other observational studies is permitted\n* History of other malignancies within past 5 years, except ductal carcinoma in situ of the breast, cervical cancer in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin. No concurrent malignancy or other serious medical condition as deemed by the investigator\n* Herbal products and supplements will generally not be allowed, but specific supplements (such as cannabidiol \\[CBD\\] oil) can be considered on a case-by-case basis by Overall PI\n* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment (e.g. estimated creatinine clearance \\\u003C 30ml\u002Fmin), unstable angina pectoris, cardiac arrhythmia, a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, stomach resection, or small bowel resection) are ineligible. Patient with active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]). Screening for HIV and hepatitis is not required for enrollment\n* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* A history of venous thromboembolism (VTE): deep vein thrombus or pulmonary embolism. An exception can be made for patients with a history of an uncomplicated venous catheter-related occlusion. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* History of hypersensitivity to imlunestrant, abemaciclib or any of the components in either medication\n* HIV-positive participants not on antiretroviral therapy are at increased risk of lethal infections when treated with marrow-suppressive therapy and should not be enrolled until their HIV is managed. If the HIV is well controlled, participants may participate in this study\n* Pregnant women are excluded from this study because embryo-fetal toxicity is a potential side effect of abemaciclib and imlunestrant. For this reason, women of child-bearing potential (WOCBP) and men must agree to use highly effective contraception prior to study entry, for the duration of treatment, and for at least 3 months after the completion of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential. All WOCBP must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of the investigational agent(s). Registration may occur prior to this pregnancy test. If the pregnancy test is positive, the patient must not receive protocol treatment and must not continue in the study. WOCBP is defined as follows:\n\n  * Any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or a bilateral oophorectomy) OR\n  * Any female who is not postmenopausal defined as:\n\n    * Age ≥ 60 years; OR\n    * Age \\\u003C 60 with intact uterus AND amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; OR\n    * Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential. Highly effective contraception methods include:\n\n  * Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n  * Female sterilization (surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\n  * Use of non-estrogen oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormone vaginal ring or transdermal hormone contraception\n  * Use of luteinizing hormone-releasing hormone (LHRH) agonist with estrogen level in post-menopausal range and one form of barrier method contraception\n* Women who are lactating. Advise lactating women to not breastfeed during treatment and for 1 week after last dose",{"count":52,"type":21},42,[54],"PHASE2","This phase II trial studies how well imlunestrant and abemaciclib work in treating patients with estrogen receptor positive (ER+) breast cancer who have tumor remaining in the blood following treatment (minimal residual disease). Estrogen can cause the growth of breast cancer cells. Imlunestrant lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Imlunestrant and abemaciclib may be effective in treating patients with ER+ breast cancer who have minimal residual disease.",[57,27,28,58,59,60],"Anatomic Stage I Breast Cancer AJCC v8","Invasive Breast Carcinoma","Localized Estrogen Receptor-Positive Breast Carcinoma","Localized Human Epidermal Growth Factor Receptor (HER2)-Negative Breast Carcinoma","2026-08-18",{"date":34,"type":35},{"date":64,"type":35},"2026-05-18",{"date":66,"type":21},"2031-04-30",{"name":68,"class":69},"Jonsson Comprehensive Cancer Center","OTHER",1,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100482618","targeted-therapy-directed-by-genetic-testing-in-treating-patients-with-locally-advanced-or-advanced-solid-tumors-the-combomatch-screening-trial-100482618","NCT05564377","Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial","Molecular Analysis for Combination Therapy Choice (ComboMATCH)","Inclusion Criteria:\n\n* Patient must have measurable disease\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \\>= 50% or Karnofsky performance status of \\>= 50%\n* Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider\n* All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)\n* Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria:\n\n  * Patients must have progressed on at least one line of standard systemic therapy OR\n  * Patients whose disease has no standard treatment that has been shown to prolong overall survival\n* Patient must meet one of the following requirements:\n\n  * Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR\n  * Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:\n\n    * Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial\n    * Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response \\[CR\\] or partial response \\[PR\\]) to any intervening therapy after collection of the tissue\n    * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR\n  * Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:\n\n    * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available\n  * NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only\n* NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial",{"count":79,"type":21},2900,[54],"This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.",[83,28,84,85,86,87,88,89,90,91,92,93,94,95,96],"Advanced Malignant Solid Neoplasm","Anatomic Stage IV Breast Cancer AJCC v8","Locally Advanced Malignant Solid Neoplasm","Malignant Female Reproductive System Neoplasm","Metastatic HER2-Negative Breast Carcinoma","Metastatic Malignant Solid Neoplasm","Recurrent Endometrial Carcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Malignant Female Reproductive System Neoplasm","Recurrent Malignant Solid Neoplasm","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Unresectable HER2-Negative Breast Carcinoma","Unresectable Malignant Solid Neoplasm",{"date":32,"type":35},{"date":99,"type":35},"2023-04-07",{"date":101,"type":21},"2030-07-01",{"name":41,"class":42},482,{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":70},"100459958","phase-1-personalized-neoantigen-peptide-based-vaccine-in-combination-with-pembrolizumab-for-treatment-of-advanced-solid-tumors-100459958","NCT05269381","Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors","A Phase I\u002FII Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)","PNeoVCA","Inclusion Criteria COHORT 1 and COHORT 2 are no longer enrolling.\n\nPHASE I PRE-REGISTRATION, ALL:\n\n* Willing to provide tissue specimens per protocol, or have clinically collected formalin-fixed paraffin-embedded (FFPE) tissue blocks, or available sequencing data available from commercial or research tests\n\n  * NOTE 1: Includes fresh tissue specimen at pre-registration, or with or clinically collected FFPE tissue blocks for complete exome and transcriptome sequencing. Patients who had tumor sequencing under certain Mayo IRB protocols and neoantigen has been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration.\n  * NOTE 2: This criteria will not apply to patients who had sequencing and neoantigen prediction previously completed.\n* Measurable disease as defined by RECIST (v 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy\n* Provide written informed consent. For pediatric patients (age 16-17 years):\n\n  * Written informed consent from legal guardian(s) and\u002For child obtained in accordance with local regulations.\n* Willing to return to enrolling institution for follow-up\n* Willing to provide blood specimens for research\n* Negative pregnancy test 7 days prior to pre-registration for persons of childbearing potential.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one ≤ 1 year prior to pre-registration\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1\n* Anticipated life expectancy \\> 6 months\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status (see specified inclusion limits for laboratory toxicity) or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5 Grade 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo).\n* The following lab values obtained ≤ 28 days prior to pre-registration:\n\n  * Hemoglobin ≥ 9.0 g\u002FdL (Must be ≥ 7 days after most recent transfusion)\n  * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 or ≥ 1.5 X 10\\^9\u002FL\n  * Platelet count ≥ 100,000\u002Fmm\\^3 or ≥ 100 X 10\\^9\u002FL (Must be ≥7 days after most recent transfusion)\n  * Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN or ≤ 5 x ULN with liver metastases\n  * Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance must be ≥ 50 ml\u002Fmin using Cockcroft-Gault formula\n  * International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy in which case PT or PTT must be within target range of therapy\n\nPHASE I REGISTRATION, ALL:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Measurable disease as defined by RECIST (v 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* The following lab values obtained ≤ 14 days prior to registration:\n\n  * Hemoglobin ≥ 9.0 g\u002Fdl\n  * ANC ≥ 1500\u002Fmm\\^3\n  * Platelet count ≥ 100,000\u002Fmm\\^3\n  * Total bilirubin ≤ 1.5 x ULN\n  * ALT and AST ≤ 3 x ULN (≤ 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy\n  * Calculated creatinine clearance ≥ 50 ml\u002Fmin using Cockcroft-Gault formula\n* Provide written informed consent\n* Willing to provide blood and tissue specimens for research\n* Willing to return to enrolling institution for follow-up\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have also received and progressed on at least one line of prior FDA-approved targeted therapy\n* Negative pregnancy test ≤ 14 days prior to registration for persons of childbearing potential only\n\n  * NOTE: If urine test cannot be confirmed negative, serum pregnancy test will be required\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one ≤ 1 year prior to pre-registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status or NCI CTCAE v5 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nPHASE II PRE-SCREENING COHORT 3 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of adenocarcinoma of the breast with estrogen receptor (ER) \\\u003C 10%, progesterone receptor (PR) \\\u003C 10%, and HER2 negative based on current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guideline\n* Stage I-III based on 7th edition of TNM staging system from American Joint Committee on Cancer (AJCC)\n* Evidence of residual disease ≥ 1 cm after neoadjuvant pembrolizumab-based chemotherapy on imaging for patients who have not had surgery\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery, willing to provide clinically collected FFPE tissue blocks, or willing to provide available sequencing data available from commercial or research test\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-SCREENING COHORT 4 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of lung NSCLC\n* No actionable EGFR mutations and ALK fusions\n* Stage II or stage III based on AJCC 8th\n* Tumor ≥ 2 cm on pre-surgery evaluation imaging (residual disease ≥ 2 cm after neoadjuvant therapy on pre-surgery evaluation imaging in patient who receives neoadjuvant therapy) for patients who have not had surgery. Patients with or without neoadjuvant chemotherapy or immunotherapy are allowed\n* Provide written informed consent\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-REGISTRATION COHORT 3 (TNBC) ONLY:\n\n* Histologically confirmed residual cancer burden 2 and 3 in surgical specimens\n\nPHASE II PRE-REGISTRATION COHORT 4 (NSCLC) ONLY:\n\n* Tumor without complete pathologic response is confirmed in pathology\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* ECOG PS of 0 or 1\n* Anticipated life expectancy \\> 6 months\n\nPHASE II PRE-REGISTRATION PILOT AND COHORT 5:\n\n* Provide written informed consent. For pediatric patients (age 16-17 years):\n\n  * Written informed consent from legal guardian(s) and\u002For child obtained in accordance with local regulations\n* Willing to proceed with surgery and provide mandatory tissue specimens or previously collected FFPE tissues for complete exome and transcriptome sequencing or available sequencing data available from commercial or research test\n\n  * NOTE: Patients who had sequencing under Mayo IRB protocol #13-000942, #14-004094, or #21-007742 and neoantigens have been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration\n* Negative pregnancy test done ≤ 7 days prior to pre-registration for persons of childbearing potential only\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Willing to employ a highly effective method of contraception from the time of preregistration through 6 months after the final vaccine cycle\n* ECOG performance status of 0 or 1\n* Anticipated life expectancy of \\> 6 months\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-REGISTRATION COHORT 5 (ILC) ONLY:\n\n* Histologically confirmed invasive lobular carcinoma or other histology with lobular features\n\n  * Histological confirmation of adenocarcinoma of the breast with invasive lobular histology or other histology with lobular features with any estrogen receptor (ER), progesterone receptor (PR), and HER2 status\n  * Stage II-IV based on the 7th edition of TNM staging system from AJCC\n  * Tumor mutational burden ≥ 10 muts\u002FMb either in tissue or blood\n\nPHASE II AND PILOT COHORT 5 REGISTRATION:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Patients will receive ≥ 2 additional cycles of maintenance pembrolizumab\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* Lab values as per Phase I registration criteria obtained ≤ 14 days prior to registration:\n* Provide written informed consent\n* Willing to provide blood specimens for research\n* Willing to return to enrolling institution for follow-up\n* Negative pregnancy test ≤ 14 days prior to registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one ≤ 1 year prior registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status NCI CTCAE v5 grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nExclusion Criteria\n\nALL PHASES:\n\n* Any of the following because study involves investigational agent whose genotoxic, mutagenic and teratogenic effects on developing fetus and newborn are unknown:\n\n  * Pregnant person\n  * Nursing person unwilling to stop breast feeding\n  * Person of childbearing potential unwilling to employ adequate contraception from registration through 6 months after final vaccine cycle\n* Co-morbid systemic illnesses or other severe concurrent disease which, in judgment of investigator, would make patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and toxicity of prescribed regimens\n* History of myocardial infarction ≤ 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy\n\nPHASE I PRE-REGISTRATION:\n\n* Acute, reversible effect(s) of prior therapy not recovered to baseline regardless of interval since last treatment\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Congestive heart failure with New York Heart Association (NYHA) class III or IV moderate to severe objective evidence of cardiovascular disease\n  * Stroke ≤ 3 months prior to pre-registration\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered treatment for primary neoplasm, except pembrolizumab\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy ≤ 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* History of active autoimmune disease (AD) that required systemic treatment in ≤ 30 days (i.e., use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded PHASE I REGISTRATION\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) ≤ 3 weeks prior to cycle 1 day 1 (C1D1) neoantigen vaccinations\n  * Radiation ≤ 2 weeks prior to C1D1 neoantigen vaccinations\n  * Major Surgery ≤ 4 weeks prior to C1D1 neoantigen vaccinations\n  * Received live vaccine ≤ 30 days prior to C1D1 neoantigen vaccinations\n  * NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE ≥ Grade 3 treatment-emergent adverse event (TEAE) to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n* Systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications ≤ 14 days prior to registration\n\n  * NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent permitted in absence of active AD\n* Patients will also be excluded based on tissue\u002FRNA\u002FDNA quality and quantity. If any of the following quality and quantity thresholds are not met, the patient will be excluded:\n\n  * Tumor tissue cellularity ≥ 30%\n  * Sufficient tissue (fresh frozen or FFPE) for both DNA and RNA sequencing with passing cellularity.\n  * ≥ 30% of tumor RNA with fragment sizes are ≥ 200 base pairs (DV200 ≥ 30)\n  * \\\u003C 10% of DNA fragments are smaller than 1 kb\n  * Sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and RNAseq according to the Mayo sequencing core (note: kits and technologies change over time, so these are not fixed numbers)\n* Evidence of leptomeningeal disease or central nervous system metastases that are untreated, symptomatic, or require steroids \\>10 mg daily prednisone equivalent\n\n  * NOTE: Patients with history of stable treated brain metastases are eligible. Stable treated metastases defined as no evidence of progression for ≥4 weeks on brain imaging (MRI or CT scan)\n\nPHASE II PRE-SCREENING:\n\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * CHF with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy ≤ 3 years prior to pre-screening\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* Known history of active AD that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-screening\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n\nPHASE II PRE-REGISTRATION\n\n* Uncontrolled illness including, but not limited to:\n\n  * Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy ≤ 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If history of prior malignancy, must not be receiving other specific treatment for cancer\n* Known history of active AD that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n* Patients will also be excluded based on tissue\u002FRNA\u002FDNA quality and quantity. If any of the following quality and quantity thresholds are not met, patient will be excluded: (1) tumor tissue cellularity equal to or greater than 30%; (2) there are ≥ 2 cores with passing cellularity; (3) ≥ 30% of tumor RNA with fragment sizes are ≥ 200 base pairs (DV200 ≥ 30); (4) \\\u003C 10% of DNA fragments are smaller than 1 kb; and (5) sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and whole transcriptome sequencing (RNAseq) according to Mayo sequencing core. (Kits and technologies change overtime, so these are not fixed numbers.)\n\nPHASE II REGISTRATION\n\n* Evidence of metastatic disease or recurrence\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) ≤ 3 weeks prior to study treatment\n  * Radiation ≤ 2 weeks prior to study treatment\n  * Major surgery ≤ 4 weeks prior to study treatment\n  * Received live vaccine ≤ 30 days prior to study treatment\n\n    * NOTE: Continuation of pembrolizumab per standard of care is allowed\n    * NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE ≥ grade 3 TEAE to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy), or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n\nOther inclusion\u002Fexclusion criteria as indicated per protocol not listed here due to limitation in number of characters (text) allowed.","16 Years",{"count":114,"type":21},138,[116,54],"PHASE1","This phase I\u002FII trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.",[28,119,120,121,84,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,85,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,88,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,96,203,204,205,206,207,208,209,210,211,212,213,214],"Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage III Merkel Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Merkel Cell Carcinoma AJCC v8","Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Locally Advanced Cervical Carcinoma","Locally Advanced Endometrial Carcinoma","Locally Advanced Gastric Adenocarcinoma","Locally Advanced Gastroesophageal Junction Adenocarcinoma","Locally Advanced Head and Neck Squamous Cell Carcinoma","Locally Advanced Hepatocellular Carcinoma","Locally Advanced Lung Non-Small Cell Carcinoma","Locally Advanced Melanoma","Locally Advanced Merkel Cell Carcinoma","Locally Advanced Renal Cell Carcinoma","Locally Advanced Skin Squamous Cell Carcinoma","Locally Advanced Triple-Negative Breast Carcinoma","Locally Advanced Unresectable Breast Carcinoma","Locally Advanced Unresectable Cervical Carcinoma","Locally Advanced Unresectable Gastric Adenocarcinoma","Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma","Locally Advanced Unresectable Renal Cell Carcinoma","Locally Advanced Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Melanoma","Metastatic Merkel Cell Carcinoma","Metastatic Renal Cell Carcinoma","Metastatic Skin Squamous Cell Carcinoma","Metastatic Triple-Negative Breast Carcinoma","Metastatic Urothelial Carcinoma","Skin Squamous Cell Carcinoma","Stage III Cervical Cancer AJCC v8","Stage III Hepatocellular Carcinoma AJCC v8","Stage III Lung Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IIIA Cervical Cancer AJCC v8","Stage IIIA Hepatocellular Carcinoma AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIB Cervical Cancer AJCC v8","Stage IIIB Hepatocellular Carcinoma AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVA Cervical Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Cervical Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVB Lung Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","Triple-Negative Breast Carcinoma","Unresectable Cervical Carcinoma","Unresectable Endometrial Carcinoma","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","Unresectable Head and Neck Squamous Cell Carcinoma","Unresectable Hepatocellular Carcinoma","Unresectable Lung Non-Small Cell Carcinoma","Unresectable Melanoma","Unresectable Merkel Cell Carcinoma","Unresectable Renal Cell Carcinoma","Unresectable Skin Squamous Cell Carcinoma","Unresectable Triple-Negative Breast Carcinoma","Unresectable Urothelial Carcinoma","Breast Adenocarcinoma","Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Invasive Breast Lobular Carcinoma",{"date":34,"type":35},{"date":217,"type":35},"2022-03-31",{"date":219,"type":21},"2028-03-31",{"name":221,"class":69},"Mayo Clinic",{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":229,"minAge":230,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":70},"100651978","phase-4-semaglutide-and-structured-lifestyle-support-to-improve-heart-and-blood-vessel-health-in-postmenopausal-obese-breast-cancer-survivors-taking-aromatase-inhibitors-100651978","NCT07769047","Semaglutide and Structured Lifestyle Support to Improve Heart and Blood Vessel Health in Postmenopausal Obese Breast Cancer Survivors Taking Aromatase Inhibitors","Breast Cancer Survivors With Obesity - Semaglutide's Impact on Preclinical Markers of Cardiovascular Disease","Inclusion Criteria:\n\n* Breast cancer diagnosed after menopause (menopause defined as the natural\u002Fspontaneous cessation of menses for at least 12 months)\n* Breast cancer (BC) diagnosed within the past five years\n* BC stage 1, 2, or 3\n* Aged 46-55 years\n* Body mass index (BMI) ≥ 30 kg\u002Fm\\^²\n* Current use of an aromatase inhibitor\n* Ability to participate in all portions of the study, including willingness to self-inject\n\nExclusion Criteria:\n\n* \\> 5% change in weight during the 3 months prior to screening and\u002For weight fluctuation of ≥ 20 pounds within the past 6 months (self-report)\n* Early menopause (menopause occurring before age 46)\n* History of established cardiovascular disease, including coronary atherosclerosis, ischemic heart disease, peripheral vascular disease, or stroke\n* Statin use\n* 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk \\> 7.5%\n* History of smoking\n* History of type 1 or type 2 diabetes\n* Family history of premature cardiovascular disease in a first-degree relative (before 45 years old in male relatives and before 55 years old in female relatives)\n* Use of chemotherapy, radiation therapy, or immunotherapy for breast cancer treatment\n* Impaired renal function \\[glomerular filtration rate (GFR) ≤ 30 ml\u002Fmin\u002F1.73 m\\^²\\]\n* Thyroid-stimulating hormone (TSH) ≥ 7 with low free thyroxine (T4)\n* Hemoglobin \\\u003C 11 mg\u002FdL\n* Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignancy, or uncontrolled psychiatric disease\n* Other anti-obesity medication used within the past 3 months\n* Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty performed \\> 1 year before screening)\n* Past or intended endoscopic and\u002For device-based therapy or removal within the last six months\n* Current or recent (within 3 months) use of medications that may cause weight gain, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers\n* Current or recent use (within 3 months) of systemic glucocorticoid therapy for over 2 weeks\n* Contraindications to glucagon-like peptide 1 (GLP-1) receptor agonist therapy\n* Currently enrolled in another clinical study involving an investigational product or participated in one and received treatment (active or placebo) in the last 30 days","FEMALE","46 Years","55 Years",{"count":233,"type":21},50,[235],"PHASE4","This phase IV trial studies whether adding semaglutide to structured lifestyle support improves heart and blood vessel health in postmenopausal obese breast cancer survivors (BCS) who are taking an aromatase inhibitor. In postmenopausal BCS who are taking an aromatase inhibitor, obesity raises the risk of heart and blood vessel problems. Semaglutide is a medicine approved by the United States Food and Drug Administration for weight loss and for lowering the risk of heart events in people with heart disease. The structured lifestyle support in this trial includes counseling on nutrition and physical activity which provides specific recommendations for individuals to follow.",[57,27,28],"NOT_YET_RECRUITING","2026-08-12",{"date":241,"type":35},"2026-08-17",{"date":243,"type":21},"2026-09-01",{"date":245,"type":21},"2035-07-30",{"name":221,"class":69},{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":229,"minAge":18,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":265,"leadSponsor":267,"locationsCount":70},"100645793","a-navigation-program-to-improve-survivorship-support-service-participation-among-non-metastatic-breast-cancer-survivors-100645793","NCT07699991","A Navigation Program to Improve Survivorship Support Service Participation Among Non-metastatic Breast Cancer Survivors","Implementation of a Navigation Program for Breast Cancer Survivors","Inclusion Criteria:\n\n* GENERAL INCLUSION (PRIMARY OBJECTIVE): Ages 18+\n* GENERAL INCLUSION (PRIMARY OBJECTIVE): Diagnosed with non-metastatic breast cancer\n* GENERAL INCLUSION (PRIMARY OBJECTIVE): Received care at Stefanie Spielman Breast Center\n* COACHING INCLUSION (SECONDARY OBJECTIVE): Referred patients who fall under any of the following:\n\n  * Black and\u002For Hispanic\n  * Ages ≥ 70\n  * Reside in a ZIP code classified as rural by United States Department of Agriculture (USDA) Rural-Urban Commuting Area (RUCA) codes\n\nExclusion Criteria:\n\n* Metastatic breast cancer at time of referral\n* Prisoners or individuals unable to consent\n* Non-English and non-Spanish speakers",{"count":255,"type":21},330,[257],"NA","This clinical trial studies whether a navigation program improves survivorship support service participation among survivors of breast cancer that has not spread from where it first started (primary site) to other places in the body (non-metastatic). Advances in treatment have caused the number of breast cancer survivors to grow. As this number increases, there are reported unmet supportive care needs in this population, including psychological distress and limitations in physical functioning. To address these needs, many cancer centers offer programming on a variety of topics including psychological services, exercise counseling, and nutrition counseling. Research has shown that while interest in these survivorship programs is high, participation remains low, especially among minority women. Navigation is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The navigation program in this trial is specifically focused on helping breast cancer survivors schedule and attend survivorship consultation appointments as well as providing additional support to underserved\u002Fvulnerable patients. A navigation program may be effective in improving survivorship support service participation among non-metastatic breast cancer survivors.",[260,57,27,28,261],"Anatomic Stage 0 Breast Cancer AJCC v8","Localized Breast Carcinoma",{"date":263,"type":35},"2026-08-14",{"date":243,"type":21},{"date":266,"type":21},"2027-12-31",{"name":268,"class":69},"Ohio State University Comprehensive Cancer Center",{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},"100471739","phase-1-testing-the-addition-of-anti-cancer-drug-zen003694-zen-3694-and-pd-1-inhibitor-pembrolizumab-to-standard-chemotherapy-nab-paclitaxel-treatment-in-patients-with-advanced-triple-negative-breast-cancer-100471739","NCT05422794","Testing the Addition of Anti-Cancer Drug, ZEN003694 (ZEN-3694) and PD-1 Inhibitor (Pembrolizumab), to Standard Chemotherapy (Nab-Paclitaxel) Treatment in Patients With Advanced Triple-Negative Breast Cancer","A Phase 1b Trial of ZEN003694 (ZEN-3694) With Pembrolizumab and Nab-Paclitaxel in Patients With Metastatic Triple-Negative Breast Cancer","Inclusion Criteria:\n\n* Participants must have a histologically or cytologically confirmed diagnosis of TNBC based on standard criteria for the disease:\n\n  * Estrogen receptor (ER) and progesterone receptor (PR) \\\u003C 10% by immunohistochemistry (IHC), and HER2-negative (per current American Society of Clinical Oncology \\[ASCO\\]\u002FCollege of American Pathologists \\[CAP\\] guidelines)\n  * If there is more than one histological result available, the most recent sample with ER, PR and HER2 results will be considered for inclusion\n  * Patients who have not had ER, PR and HER2 testing and thus, ER, PR and HER2 status is unknown, are not eligible\n  * Participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation\n* Participants must have disease that is unresectable locally advanced or metastatic\n* DOSE ESCALATION COHORT: Known PD-L1 status is not required prior to study enrollment. Central PD-L1 testing (on archival tumor tissue) will occur retrospectively\n* DOSE ESCALATION COHORT: Any number of prior lines of therapy are allowed in the metastatic setting. Prior immune checkpoint inhibitor allowed in any setting\n* DOSE ESCALATION COHORT: Evaluable or measurable disease per RECIST 1.1 criteria\n* DOSE EXPANSION COHORT: PD-L1 status must be negative. Standard local testing with any PD-L1 antibody that has been validated in a Clinical Laboratory Improvement Act (CLIA)- certified environment will be acceptable for including patients on trial. Primary or metastatic samples may be tested for PD-L1 status. Central confirmation will occur retrospectively. For patients in whom a baseline research tumor tissue biopsy is not performed (e.g. site of disease is not safely accessible), archival tissue should be provided for central confirmatory PD-L1 testing\n* DOSE EXPANSION COHORT: 0-1 prior lines of systemic therapy in the metastatic setting\n* DOSE EXPANSION COHORT: Participants must have measurable disease per RECIST 1.1 criteria\n* DOSE EXPANSION COHORT: Participants must have disease that is amenable to biopsy as judged by the treating investigator and must be willing to undergo pre- and on-treatment tumor biopsies, if safely accessible\n* Age \\>= 18 years\n\n  * Because no dosing or adverse event data are currently available on the use of ZEN003694 (ZEN-3694) in combination with nab-paclitaxel and pembrolizumab (MK-3475) in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Absolute neutrophil count \\>= 1,000\u002FmcL\n* Platelets \\>= 100,000\u002FmcL\n* Hemoglobin \\>= 9 g\u002FdL or \\>= 5.6 mmol\u002FL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (or =\\\u003C 2.0 x ULN in patients with documented Gilbert's Syndrome)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3.0 x institutional ULN or ≤ 5.0 x institutional ULN for participants with documented liver metastases\n* Serum or plasma creatinine =\\\u003C 1.5 x institutional ULN OR glomerular filtration rate (GFR) \\>= 60 mL\u002Fmin (based on the calculated chronic kidney disease epidemiology (CKD-EPI) glomerular filtration rate estimation\n* International normalized ratio (INR) or prothrombin time (PT): =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT): =\\\u003C 1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial as long as their anti-retroviral therapy does not have the potential for drug-drug interactions as judged by the treating investigator\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with history of treated central nervous system (CNS) metastases are eligible, provided they meet the following criteria:\n\n  * Disease outside the CNS is present\n  * Recovery from acute toxicity associated with the treatment to =\\\u003C Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 or baseline (with the exception of alopecia), with no requirement for escalating doses of corticosteroids over the past 7 days\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer are allowed\n* Patients should be New York Heart Association Functional Classification of class 2B or better\n* Peripheral neuropathy grade =\\\u003C 1\n* Ability to swallow and retain oral medications\n* Participants may not have had cytotoxic chemotherapy, immunotherapy, major surgery (other than diagnostic surgery, dental surgery or stenting), or other investigational therapy within 3 weeks prior to entering the study\n* Participants may not have had radiotherapy within 1 week prior to entering the study. Patients may not have had \\> 25% of their bone marrow radiated. Stereotactic radiosurgery (SRS) within 1 week prior to entering the study will be allowed\n* Participants may not have received tyrosine kinase inhibitors (TKIs) or small molecules within 5 half-lives or 2 weeks (whichever is shorter) of study entry\n* Patients who have experienced adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) must have recovered, with the exception of alopecia or as otherwise specified in the eligibility criteria\n* The effects of the combination of ZEN003694 (ZEN-3694) and MK-3475 on the developing human fetus are unknown. For this reason and because BETi and PD-1 blocking agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after study completion. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of ZEN003694 (ZEN-3694), MK-3475 and nab-Paclitaxel administration. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to registration. Childbearing potential is defined as: participants who have not reached a postmenopausal state (\\>= 12 continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and\u002For uterus)\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and\u002For family member available will also be eligible\n\nExclusion Criteria:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 (ZEN-3694), nab-paclitaxel, or pembrolizumab\n* Patients with uncontrolled intercurrent illness\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Any gastrointestinal (GI) disorder that may affect absorption of oral medications in the opinion of the treating investigator, such as malabsorption syndrome or major bowel or stomach resection\n* Pregnant women are excluded from this study because ZEN003694 (a BETi agent) and MK-3475 have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZEN003694 (ZEN-3694), breastfeeding should be discontinued if the mother is treated with ZEN003694 (ZEN-3694). These potential risks may also apply to MK-3475 and nab-paclitaxel\n* Patients who have previously received ZEN003694 (ZEN-3694) or who have been treated with an investigational BET inhibitor\n* DOSE EXPANSION COHORT: Prior exposure to immune checkpoint inhibitors in the metastatic setting. PD-1 or PD-L1 inhibitors in the neo-\u002Fadjuvant setting are allowed if at least 12 months have elapsed since the end of adjuvant systemic treatment to development of metastatic disease\n* DOSE EXPANSION COHORT: Prior exposure to taxane-based therapy in the metastatic setting. Taxane in the neo-\u002Fadjuvant setting is allowed if at least 12 months have elapsed since the end of adjuvant systemic treatment to development of metastatic disease\n* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694 (ZEN-3694). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients receiving any medications or substances that are Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed\n* Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694 (ZEN-3694)\n* Myocardial infarction or unstable angina within 6 months prior to the first dose of ZEN003694 (ZEN-3694)\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the study principal investigator (PI)\n* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\n* Has a known history of active tuberculosis (TB)\n* Has received a live vaccine within 30 days of planned treatment start. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, Bacille Calmette-Guerin (BCG), and typhoid vaccine. Seasonal flu vaccines that do not contain live virus are permitted. Coronavirus disease-2019 (COVID-19) vaccines received within the last 30 days are also permitted\n* Participants with known or suspected extensive bone marrow infiltration per radiographic assessment, laboratory assessment, or bone marrow sampling (e.g., aspiration or biopsy), determined to be clinically significant by the treating investigator",{"count":277,"type":21},57,[116],"This phase Ib trial tests the safety and tolerability of ZEN003694 in combination with an immunotherapy drug called pembrolizumab and the usual chemotherapy approach with nab-paclitaxel for the treatment of patients with triple negative-negative breast cancer that has spread to other parts of the body (advanced). Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Immunotherapy with monoclonal antibodies, such as pembrolizumab may help the body's immune system attach the cancer and may interfere with the ability of tumor cells to grow and spread. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. Combination therapy with ZEN003694 pembrolizumab immunotherapy and nab-paclitaxel chemotherapy may help shrink or stabilize cancer for longer than chemotherapy alone.",[28,84,145,163,207],"2026-08-08",{"date":283,"type":35},"2026-08-11",{"date":285,"type":35},"2023-05-18",{"date":287,"type":21},"2027-03-31",{"name":41,"class":42},6,{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":229,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":321},"100650009","a-blended-e-health-intervention-to-improve-fear-of-progression-in-women-with-gynecologic-or-breast-cancer-100650009","NCT07741968","A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer","An e-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer","Inclusion Criteria:\n\n* Women with stage III or IV GYN (ovarian, endometrial, cervical, vulvar\u002Fvaginal) or breast cancer who are at least 2 months from initial diagnosis OR Women with stage I or II endometrial, ovarian, or breast cancer with carcinosarcoma histology OR Women with stage I or II triple negative breast cancer\n* Score ≥ 34 on the Fear of Progression Short-Form, indicating dysfunctional levels\n* Age 18 or older; able to read and understand English\n* Patients can be on active treatment or surveillance. They can be no evidence of disease (NED), recurrent or with progressive disease\n\nExclusion Criteria:\n\n* Enrolled in hospice\n* Ongoing uncontrolled active psychiatric condition that, in the opinion of the investigator, would interfere in the conduct of the study (e.g., mood disorders, psychosis disorders, or substance use), Major depression as assessed by Patient Health Questionnaire-9 (PHQ-9)\n* Non-English speaking\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)\n* Current participation in a mind-body or mindfulness education program within the past six weeks",{"count":298,"type":21},126,[257],"This clinical trial studies whether an intervention supported by technology (blended e-health intervention) works to improve fear of progression (FOP) in women with gynecologic or breast cancer. FOP is the fear patients experience from the possibility that their cancer could grow, spread, or get worse. Managing FOP is a leading unmet concern of cancer patients. High levels of FOP are associated with distress, depression, and increased health care costs, despite this, access to resources to address FOP remain limited. The blended e-health intervention in this trial offers remote group sessions along with online sessions to help patients access the information. Session content incorporates values-based goal setting and skills practices to manage unhelpful beliefs about worry and promote helpful coping behaviors. The sessions may help patients recognize unhelpful thoughts and behaviors which reinforce worry. A blended e-health intervention may be an effective way to improve FOP in women with gynecologic or breast cancer.",[57,27,28,84,302,303,304,86,305,306,166,307,308,182,309,310,195,311],"Breast Carcinoma","Breast Mixed Epithelial\u002FMesenchymal Metaplastic Carcinoma","Endometrial Carcinoma","Ovarian Carcinoma","Ovarian Carcinosarcoma","Stage III Vaginal Cancer AJCC v8","Stage III Vulvar Cancer AJCC v8","Stage IV Vaginal Cancer AJCC v8","Stage IV Vulvar Cancer AJCC v8","Uterine Corpus Carcinosarcoma","2026-08-06",{"date":314,"type":35},"2026-08-10",{"date":316,"type":21},"2027-02-22",{"date":318,"type":21},"2028-01-16",{"name":320,"class":69},"City of Hope Medical Center",11,{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":229,"minAge":18,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":70},"100596350","5-strain-probiotic-formulation-in-hr-positive-breast-cancer-receiving-aromatase-inhibitor-to-prevent-bone-loss-100596350","NCT07044310","5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss","Phase 2 Trial of 5-Strain Probiotic Formulation in Hormone Receptor-Positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss","Inclusion Criteria:\n\n* Female age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2\n* Histologically confirmed anatomical stage 0-III hormone receptor-positive breast cancer\n* Will be starting on an aromatase inhibitor (letrozole, anastrozole, or exemestane) ± ovarian function suppression (OFS) per treating physician's discretion\n* Absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 (prior to registration)\n* Platelet count ≥ 75,000\u002Fmm\\^3 (prior to registration)\n* Hemoglobin ≥ 9.0 g\u002FdL (prior to registration)\n* Creatinine ≤ 2 x upper limit of normal (ULN) (prior to registration)\n* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) ≤ 2 x ULN (prior to registration)\n* Albumin ≥ 3 g\u002FdL (prior to registration)\n* Willing and able to provide research stool and blood samples\n* Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only (\\\u003C 60 years old with intact uterus)\n* Capable of providing valid informed consent\n* Willing to return to enrolling institution for all study visits (blood draws, etc)\n\nExclusion Criteria:\n\n* Requires prolonged systemic antibiotic therapy for other conditions and recent systemic antibiotic ≤ 14 days prior to registration\n* Fecal microbiota transplant (FMT) ≤ 6 months prior to registration\n* FMT with an associated serious adverse event related to the FMT product or procedure\n* Co-morbid systemic illnesses or other severe concurrent diseases which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of over-the-counter probiotics\n* Immunocompromised patients including patients known to be HIV positive or those on chronic steroids \\> 20 mg prednisone a day or prednisone-equivalent. Note: Must be off systemic steroids ≥ 90 days prior to registration. However, topical steroids, inhalants, or steroid eye drops are permitted\n* History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis\n* History of chronic diarrhea\n* History of celiac disease\n* Currently has a colostomy\n* Intraabdominal surgery related to gastrointestinal tract ≤ 60 days prior to registration\n* Evidence of active, severe colitis\n* History of short gut syndrome or motility disorders\n* Requires the daily use of medications to manage bowel hypermotility, such as imodium or lomotil\n* Active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive products) prior to registration. Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment ≤ 30 days prior to registration are not excluded\n* History of osteoporosis or hyperparathyroidism\n* History of untreated vitamin D deficiency\n* Receiving or will receive bisphosphonates during study period (alendronate, risedronate, ibandronate, pamidronate, or zolendronic acid) or denosumab\n* Patients who received oral bisphosphonate within ≤ 12 weeks, intravenous (IV) zoledronic acid (Reclast) ≤ 52 weeks, or denosumab ≤ 24 weeks will also be excluded\n* Known hypersensitivity to any component of study product (including known inulin intolerance)\n* Known hypersensitivity to \\> 4 first-line antimicrobial therapies against akkermansia muciniphila, clostridium beijerinckii, clostridium butyricum, anaerobutyricum hallii, including penicillin, piperacillin, tetracycline, amoxicillin, or ampicillin\n* Known hypersensitivity to \\> 4 first line antimicrobial therapies against bifidobacterium infantis Bi-26TM, including gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin, vancomycin\n* Received an experimental product ≤ 30 days prior to registration\n* Receiving or will receive CDK 4\u002F6 inhibitor (abemaciclib, ribociclib, or palbociclib)\n* Received chemotherapy ≤ 30 days prior to registration",{"count":330,"type":21},38,[54],"This phase II trial tests how well a probiotic, WBF-038, works in preventing bone loss in patients with early-stage hormone receptor-positive breast cancer who are starting treatment with aromatase inhibitors. Aromatase inhibitors are a drug that blocks the activity of an enzyme called aromatase, which the body uses to make estrogen in the ovaries and other tissues. Blocking aromatase lowers the amount of estrogen made by the body, which may stop the growth of cancer cells that need estrogen to grow. Aromatase inhibitors are used to treat some types of breast cancer or to keep it from coming back. Aromatase inhibitors can affect bone health, weight, blood sugar, and waist size. WBF-038 is a combination of both prebiotics and probiotics, designed to improve metabolic health. Giving WBF-038 may improve bone turnover, bone health, blood sugar, weight, and waist circumference in patients with early-stage hormone receptor-positive breast cancer starting on adjuvant endocrine therapy with an aromatase inhibitor.",[260,57,27,28,30],{"date":314,"type":35},{"date":336,"type":35},"2025-07-25",{"date":338,"type":21},"2027-07-25",{"name":221,"class":69},{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":22,"phases":349,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":70},"100464431","neoadjuvant-breast-cancer-time-restricted-eating-100464431","NCT05327608","Neoadjuvant Breast Cancer Time Restricted Eating","Time Restricted Eating for Patients With HER2- Negative Breast Cancer Receiving Neoadjuvant Chemotherapy","Inclusion Criterion\n\nIndividuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:\n\n1. Patient must be ≥ 18 years of age at time of consent and must be able to understand and provide informed consent.\n2. BMI 25-40 at time of enrollment.\n3. Patients must have an ECOG performance status of 0 or 1.\n4. Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma.\n\n   a. Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy.\n5. Patients must have clinical stage I-III (utilizing TNM criterion) at diagnosis.\n6. Clinical T size must be ≥ 1.5cm if there is no radiographic or clinical evidence of axillary lymph node involvement. Any size tumor is allowed if axillary lymph nodes appear to be involved.\n7. Patient must be willing and able (have no contraindication) to receive recommended standard neoadjuvant therapy consisting of at least 16 weeks of planned neoadjuvant chemotherapy.\n8. Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician.\n9. Patient must be willing and able (have no contraindication) to participate in TRE consisting of 16 weeks\n10. Women of childbearing potential and sexually active males must use accepted and effective method(s) of contraception or abstain from sexual intercourse for the duration of their participation in the study and for 6 months after the last study intervention.\n11. Patient must have a personal email address, an internet-capable device, and the ability\u002F willingness to read and reply to email every day for the duration of the study.\n\nExclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Clinical T4 and\u002For N3 disease, including inflammatory breast cancer.\n2. Any prior treatment for the current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy.\n3. Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive from the time of registration, while on study treatment, and until at least 6 months after the last study intervention.\n4. Patients with type 1 diabetes, or type 2 diabetes treated with insulin.\n5. Patients with a history of eating disorder\n6. Patients who work on a rotating shift schedule.\n7. Patients must not have impaired decision-making capacity.\n8. Patients who are not English speaking as study staff is only able to provide the study intervention measurement tool.\n9. Patients that are \\>2 weeks into starting neoadjuvant chemotherapy regimen.",{"count":348,"type":21},55,[54],"A phase II study to evaluate an innovative approach of following time restricted eating (TRE) in patients with early-stage breast cancer who will start neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. Participants at baseline will have a body mass index (BMI) of (25-40) and engage in a TRE 16:8 schedule which includes 16 hours of fasting and 8 hours of eating. Patients will continue TRE for 16 weeks while receiving NCT. For patients who report at the time of the 2-3 week clinic visit that they are finding it challenging to adhere to the 16:8 TRE, instructions will be provided about alternative measures such as changing the time of the day they fast, dietary modifications and finally changing to a 14:10 schedule if other measures fail. For patients requiring NCT for longer than 16 weeks, they will be encouraged to continue TRE. Adherence calculation for the primary endpoint will include data for the first 16 weeks and then monitored separately for any additional optional fasting beyond the first 16 weeks. Adherence to TRE will be self-reported by patients daily through electronic surveys through RedCap and approximately every 2-3 weeks (+\u002F- 5 days) by the research team during their clinic visit.",[57,27,28,352,353,354,58],"Breast Ductal Carcinoma in Situ","HER2 Negative Breast Carcinoma","Hormone Receptor Positive Breast Carcinoma",{"date":283,"type":35},{"date":357,"type":35},"2022-07-28",{"date":359,"type":21},"2027-05-01",{"name":361,"class":69},"Thomas Jefferson University",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":229,"minAge":18,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":22,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":70},"100592927","phase-1-an-optimized-ultrasound-twinkling-marker-for-the-imaging-of-lymph-nodes-in-patients-with-clinically-node-positive-breast-cancer-the-utmost2-trial-100592927","NCT06999798","An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial","A Phase 1 Study in Patients With Clinically Node-Positive Breast Cancer to Assess the Safety, Ultrasound Conspicuity, and Migration of an Optimized Ultrasound Twinkling Marker Observed for Sonographic Targeting (UTMOST2 Trial)","Inclusion Criteria:\n\n* Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node\n* Surgical management will be determined by the surgeon, who will decide if preoperative Iodine (I)-125 seed localization of the positive node is necessary or if they will retrieve the positive node with intraoperative ultrasound guidance. During surgery, the targeted node, its associated biopsy markers, I-125 seed if placed, and optimized twinkling marker will be resected. The position of the marker in the lymph node or proximity to the node will be noted from the surgical and pathology documentation\n* Surgery will be performed by one of the surgeons in the Division of Breast and Melanoma Surgical Oncology (Doctor \\[Dr.\\] Judy Boughey, Dr. Amy Degnim, Dr. Tina Hieken, Dr. Jeffrey Johnson, Dr. Mary Mrdutt, Dr. Shon Black)\n* Patients must be able to understand the study procedures and comply with them for the entire length of the study\n* No contraception is necessary or required\n\nExclusion Criteria:\n\n* Patients who are pregnant\n* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements\n* Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention",{"count":370,"type":21},20,[116],"This phase I trial studies the performance, including ultrasound visibility, of an optimized ultrasound twinkling marker in imaging lymph nodes in patients with clinically node-positive breast cancer. In patients with biopsy-proven breast cancer, biopsy markers are used to identify the sites of cancer involvement in both the breasts and lymph nodes. These biopsy markers are critical for guiding surgical management many months after the marker is placed. For breast radiologists and breast surgeons, there is a need for simple, consistent visibility of biopsy markers by ultrasound, particularly several months after marker placement. Ultrasound is the imaging method of choice, particularly for lymph nodes in the armpit (axilla). Ultrasound is non-ionizing and is more comfortable for patients compared to mammography. However, ultrasound visibility of these markers is challenging and inconsistent, with ultrasound failing to detect the marker approximately 25% of the time. The Mayo-designed investigational biopsy marker takes advantage of an ultrasound phenomenon called twinkling artifact. The Mayo-designed optimized ultrasound twinkling marker may work better than standard biopsy clip marker in imaging lymph nodes in patients with clinically node-positive breast cancer.",[27,28,84,374],"Locally Advanced Breast Carcinoma","2026-08-04",{"date":312,"type":35},{"date":378,"type":35},"2025-08-29",{"date":380,"type":21},"2026-11-30",{"name":221,"class":69},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":229,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":398,"locationsCount":70},"100506431","online-nutrition-education-to-decrease-the-side-effects-of-chemotherapy-in-patients-with-breast-cancer-100506431","NCT05874297","Online Nutrition Education to Decrease the Side Effects of Chemotherapy in Patients With Breast Cancer","Feasibility and Pilot Study Testing an Online Digital Intervention to Improve Symptom Management During Breast Cancer Chemotherapy","ONE","Inclusion Criteria:\n\n* 18 years of age or older.\n* Stage I-III breast cancer.\n* Current breast cancer patients scheduled to receive ddAC-T(+\u002F-C), TCHP, or TCPembro-AC chemotherapy at Fred Hutch South Lake Union (can enroll prior to receipt of 2nd cycle).\n* Not pregnant and no plan to become pregnant during chemotherapy treatment.\n* Ability to speak and read English.\n* Access to smartphone, tablet, or computer and Internet.\n* Willing and able to complete all study activities through the end of chemotherapy, including completing online questionnaires and telephone assessments.\n* Women must not be pregnant at time of enrollment based on self-report.\n* Able to understand and willing to sign written informed electronic (e) consent in English.",{"count":233,"type":21},[257],"This trial tests an online nutrition education program focused on decreasing nutrition-related side effects of chemotherapy in patients with breast cancer. Patients undergoing chemotherapy are at risk for complications such as diarrhea or constipation which can lead to poor nutritional intake and malabsorption of nutrients. This study is testing the effects of information delivered via the Cook for Your Life website in conjunction with standard clinical care to improve symptom management during chemotherapy treatment for breast cancer, which could serve as a new model for supportive oncology care.",[57,27,28],{"date":312,"type":35},{"date":396,"type":35},"2026-07-15",{"date":266,"type":21},{"name":399,"class":69},"Fred Hutchinson Cancer Center",{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":407,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":22,"phases":410,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":425},"100467889","phase-1-testing-the-safety-and-efficacy-of-the-combination-of-two-anti-cancer-drugs-zen003694-and-abemaciclib-for-adult-and-pediatric-patients-12-17-years-with-metastatic-or-unresectable-nut-carcinoma-breast-cancer-and-other-solid-tumors-100467889","NCT05372640","Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors","A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4\u002F6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors","Inclusion Criteria:\n\n* Participants must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective\n* Dose Escalation Cohort Only: Participants must have evaluable disease or measurable disease per RECIST 1.1 criteria\n* Dose Expansion Cohort Only:\n\n  * Participants must have a diagnosis of NUT carcinoma (NC) based on standard criteria for the disease, with diagnostic testing performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory:\n\n    * Ectopic expression of NUT protein per World Health Organization (WHO) criteria as determined by immunohistochemistry (IHC) testing, OR\n    * Detection of the NUT gene translocation as determined by fluorescence in situ hybridization (FISH) testing, OR\n    * Detection of the NUT gene translocation as determined by either deoxyribonucleic acid (DNA) next-generation sequencing (NGS) or ribonucleic acid (RNA) sequencing.\n  * Participants must have measurable disease per RECIST 1.1 criteria\n* Any number of prior lines of therapy in the metastatic setting are allowed, including prior BET inhibitor therapy and prior CDK4\u002F6 inhibitor therapy\n* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade =\\\u003C 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy\n* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy\n* Participants may have previously undergone surgical resection\n* Age \\>= 12 years. Patients 12-17 years of age must be \\> 40 kg at enrollment. Patients 12-17 years of age will not participate in the mandatory tumor biopsies. Since there is no data on patients less than 18 years of age, this population may require lower doses and additional safety precautions and should be closely monitored. Because no dosing or adverse event data are currently available on the use of ZEN003694 in combination with abemaciclib in patients \\\u003C 12 years of age, younger children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 for participants \\>= 16 years of age, Lansky \\>= 50% if \\\u003C 16 years of age\n* Hemoglobin \\>= 8 g\u002FdL; Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion\n* Absolute neutrophil count \\>= 1.5 x 10\\^9\u002FL\n* Platelets \\>= 1 x 10\\^11\u002FL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) for age. Patients with Gilbert's syndrome with a total bilirubin =\\\u003C 2.0 times ULN and direct bilirubin within normal limits are permitted\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN for age\n* Serum or plasma creatinine =\\\u003C 1.5 x institutional ULN OR calculated creatinine clearance \\>= 50 mL\u002Fmin (via the chronic kidney disease epidemiology \\[CKD-EPI\\] glomerular filtration rate estimation) for participants \\>= 18 years old, or 60 mL\u002Fmin\u002F1.73m\\^2 for patients 12-17 years as calculated based on bedside Schwartz formula\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Hepatitis C (HepC antibody) testing is required. Hepatitis C RNA is optional; however, a confirmatory negative Hepatitis C RNA test must be obtained to be able to enroll participants with positive Hepatitis C antibody due to prior resolved disease\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and has been clinically stable for at least 1 month. Patients must meet the following criteria:\n\n  * Disease outside the CNS is present\n  * Recovery from acute toxicity associated with the treatment to =\\\u003C CTCAE grade 1 or baseline (with the exception of alopecia), with no requirement for escalating doses of corticosteroids over the past 7 days\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients should be New York Heart Association Functional Classification of class 2B or better\n* Ability to swallow and retain oral medications\n* The effects of ZEN00364 and abemaciclib on the developing human fetus are unknown. For this reason and because BETi and CDKi-inhibiting agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women of child-bearing potential must have a negative pregnancy test prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 weeks after completion of ZEN003694 and abemaciclib administration\n\n  * For female subjects of child-bearing potentially receiving ZEN003694, hormonal means of birth control alone, such as oral, injectable, dermal, subdermal or topical contraceptives are NOT acceptable forms of birth control given that their efficacy has not been evaluated when given in combination with the investigational drugs. \"Adequate contraception\" is defined as the following:\n\n    * Contraceptive methods with a failure rate of =\\\u003C 1% used in combination with the barrier method. The following contraceptive methods are acceptable to use in combination with the barrier method: intrauterine device (IUD), intrauterine system (IUS), or oral contraceptive pills (OCPs) that meet the \\\u003C 1% failure rate as stated in the product label. Note: Hormonal IUDs\u002FOCPs may only be used if the following criteria are met: male condoms are required AND subjects are informed of the potential for reduced systemic hormone levels from the IUD\u002FOCP when taking ZEN003694. Alternatively, male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, \"documented\" refers to the outcome of the investigator's\u002Fdesignee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records\n  * Male subjects with female partners of child-bearing potential must use one of the following contraceptive methods:\n\n    * Vasectomy with documentation of azoospermia OR\n    * Condom use PLUS partner use of a highly effective contraceptive (=\\\u003C 1% rate of failure per year) such as intrauterine device or system, or hormonal birth control such as contraceptive subdermal implant, combined estrogen and progestogen oral contraceptive, injectable progestogen, contraceptive vaginal ring, or percutaneous contraceptive patches\n  * Male subjects should not donate sperm while on study and for 12 weeks after the last dose of study medication. Male subjects whose partners are or become pregnant must continue to use condoms for 12 weeks after the last dose of study medication\n* Women of childbearing potential must have a negative pregnancy test within 7 days of starting treatment\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and\u002For family member available may be eligible after discussion with the Principal Investigator of this study. There will be a separate assent process for minors\n\nExclusion Criteria:\n\n* Participants who have had cytotoxic chemotherapy, immunotherapy, or other investigational therapy within 2 weeks prior to entering the study. There is a two-week required washout period for previous BET inhibitor therapy\n* Participants who have had radiotherapy within at least 2 weeks prior to entering the study. Stereotactic radiosurgery (SRS) within 1 week prior to entering the study will be allowed\n* Participants who have had major surgery within 3 weeks prior to entering the study\n* Participants who have received tyrosine kinase inhibitors (TKIs) or small molecules within 5 half-lives or 1 week (whichever is shorter) of study entry\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 or abemaciclib\n* Patients requiring medications or substances that are strong inhibitors or strong inducers of CYP3A4 or CYP3A enzymes are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694 and abemaciclib. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002Ftable.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients with uncontrolled intercurrent illness, including but not limited to: ongoing or active infection requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment (e.g. estimated creatinine clearance \\\u003C 30ml\u002Fmin), history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea that, in the judgment of the investigator, would preclude participation in this study\n* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694. As proton pump inhibitors (PPIs), H2 receptor antagonists, and antacids may alter the pharmacokinetics of ZEN003694 by reducing ZEN003694 exposure, patients receiving proton pump inhibitors are ineligible. If H2 blockers or other acid reducing agents are used concomitantly with ZEN003694, a staggered dosing schedule should be used. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Pregnant women are excluded from this study because ZEN003694 is a BETi agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZEN003694, breastfeeding should be discontinued if the mother is treated with ZEN003694. These potential risks may also apply to other agents used in this study\n* Fridericia's formula-corrected QT interval (QTcF) \\>= 450 msec on screening electrocardiogram (ECG) by Fredericia (machine or manual read allowed). Patients should avoid medications which prolong the QT\n* Patients receiving any medications or substances that are Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) or Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed\n* Patients with radiation to \\> 25% of the bone marrow\n* Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694\n* Myocardial infarction or unstable angina within 6 months prior to the first dose of ZEN003694\n* Impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 and\u002For abemaciclib\n* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest","12 Years",{"count":409,"type":21},45,[116],"This phase I trial tests the safety, side effects, and best dose of ZEN003694 when given together with abemaciclib in treating patients with NUT carcinoma, breast cancer or other solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ZEN003694 and abemaciclib may help shrink or stabilize cancer in patients with NUT carcinoma, breast cancer or other solid tumors.",[28,84,413,88,414,415,96,416],"Metastatic Breast Carcinoma","Metastatic NUT Carcinoma","Unresectable Breast Carcinoma","Unresectable NUT Carcinoma","2026-07-30",{"date":419,"type":35},"2026-07-31",{"date":421,"type":35},"2023-08-10",{"date":423,"type":21},"2027-06-07",{"name":41,"class":42},7,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":229,"minAge":4,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":289},"100524767","phase-2-prevention-of-frailty-with-fisetin-and-exercise-in-breast-cancer-survivors-100524767","NCT06113016","Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors","A Phase II Randomized Placebo-Controlled Study of Fisetin and Exercise to Prevent Frailty in Breast Cancer Survivors","PROFFi","Inclusion Criteria:\n\n* Women who are postmenopausal at the start of study treatment\n\n  * Postmenopausal status will be established as follows: Women who are 50 years or older and who are not menstruating for greater than 12 months will be considered postmenopausal. Women who are less than 50 years with an intact uterus and ovaries must have chemically induced menopause (e.g., ovarian suppression) to be considered postmenopausal\n* Women with a diagnosis of early-stage breast cancer (stage I, II, III) treated with neo\u002Fadjuvant chemotherapy within 12 months of starting study treatment\n* No evidence of active\u002Frecurrent breast cancer or other serious chronic illnesses\n* Have evidence of pre-frail health, defined as a 6-minute walk distance (400-480m) at baseline\n* Platelets \\> 60,000\u002Fmm\\^3\n* White blood cell count \\> 2,000\u002Fmm\\^3\n* Absolute neutrophil count \\> 500\u002Fmm\\^3\n* Hemoglobin ≥ 8.0 g\u002FdL\n* Total bilirubin ≤ 3.0 X upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) ≤ 4.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 4.0 x ULN\n* Estimated glomerular filtration rate (eGFR) of ≥ 30mL\u002Fmin\u002F1.73m\\^2 per the Modification of Diet in Renal Disease (MDRD) calculation. GFR (mL\u002Fmin\u002F1.73 m²) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American)\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days prior to the start of study treatment. Exceptions include: trastuzumab, pertuzumab, pembrolizumab, tamoxifen, and aromatase inhibitors\n* Surgery and\u002For radiation within the last 30 days of starting study treatment (Exception: invasive non-major procedures such as an outpatient biopsy)\n* Subjects taking medications that are considered prohibited\n\n  * Exception: Subjects taking any of the medications under \"Temporary medication adjustment required\" may participate if they are otherwise eligible AND the medication can be safely withheld (from immediately before the 1st study agent administration until at least 10 hours after the last study agent administration, for each dosing interval)\n* On herbal and natural medications with possible senolytic properties (i.e., curcumin, kava kava, St. John's wort) and are unable or unwilling to hold its administration 2 days prior to and during study treatment dosing. Exceptions include cannabidiol (CBD), vitamins, probiotics, and fish oil. Other herbal and natural medications may be permitted or prohibited per clinician discretion\n* Subjects taking potentially senolytic agents within the last year: fisetin, quercetin, luteolin, dasatinib or imatinib (or other tyrosine kinase inhibitors), piperlongumine, or navitoclax\n* Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc.)\n* Issues with tolerating oral medication (such as but not limited to, inability to swallow pills (gastrostomy \\[g\\]-tubes not allowed), malabsorption issues, ongoing nausea or vomiting during screening, history of Crohn's, gastric bypass\u002Freduction, or celiac disease)\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Currently participating in another intervention research study seeking to improve functional status, alleviate frailty, muscle strength, exhaustion\u002Ffatigue, or cognitive function",{"count":435,"type":21},164,[54],"This phase II trial tests how well fisetin and exercise works in preventing frailty in breast cancer survivors. Fisetin is a natural substance found in strawberries and other foods and is available as a nutritional supplement. Nutritional supplements may be useful in eliminating cells that have undergone a process called senescence. Senescence is when a cell ages and permanently stops dividing but does not die. Over time, large numbers of these cells build up in tissues throughout the body and can release harmful substances that cause inflammation and damage nearby healthy cells. Giving fisetin may eliminate senescent cells in patients with breast cancer undergoing physical activity.",[439,27,28,440],"Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8","Early Stage Breast Carcinoma","2026-07-28",{"date":417,"type":35},{"date":444,"type":35},"2024-07-23",{"date":446,"type":21},"2031-10-31",{"name":68,"class":69},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":229,"minAge":455,"maxAge":456,"enrollmentInfo":457,"targetDuration":4,"studyType":22,"phases":459,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":470,"locationsCount":70},"100648516","web-based-lifestyle-program-mhealth-and-ema-intervention-to-improve-weight-loss-in-rural-stage-i-iii-postmenopausal-breast-and-endometrial-cancer-survivors-hero-c-trial-100648516","NCT07723235","Web-based Lifestyle Program, mHealth and EMA Intervention, to Improve Weight Loss in Rural Stage I-III Postmenopausal Breast and Endometrial Cancer Survivors, HERO-C Trial","Health Engagement for Rural Ohio Cancer Survivors (HERO-C)","Inclusion Criteria:\n\n* Body mass index (BMI) ≥ 25kg\u002Fm\\^2\n* Age: 40-69 years\n* 1-5 years post-diagnosis of stage I-III postmenopausal breast cancer or stage I-III endometrial cancer\n* No known evidence of recurrence (local or distant) or second, primary cancer\n* No prior history of new other malignancy since their breast or endometrial cancer diagnosis (other than non-melanoma skin cancer)\n* Not currently participating in any weight loss programs, no personal trainer, and not meeting the physical activity guidelines\n* No use of any anti-obesity medications in the last 6 months and no plan to start anti-obesity medications during the study period\n* The ability to walk two blocks without a walker or cane\n* The ability to speak and read English\n* Have access to internet with a computer, tablet, or smart phone\n* Live in rural counties in Ohio and not planning to move away during the study\n* Are not pregnant, breastfeeding or less than 12-month post-partum and do not plan to become pregnant during the study\n\nExclusion Criteria:\n\n* Severe medical conditions, such as unstable cardiovascular disease or digestive disorders, that would preclude physical activity and dietary intervention\n* Lack of physician clearance if determined necessary by the Physical Activity Readiness Questionnaire (PAR-Q+)\n* Acute physical limitations for unsupervised exercises at home\n* Unable to give informed consent","40 Years","69 Years",{"count":458,"type":21},90,[257],"This clinical trial identifies the needs and preferences of rural stage I-III postmenopausal breast and endometrial cancer survivors and evaluates the impact of an adaptive, online program, mobile (m)Health + ecological momentary assessment (EMA) intervention, on lifestyle modification and their weight loss efforts. Obesity, a condition marked by an abnormally high, unhealthy amount of body fat, is associated with lower physical and psychological well-being, higher risk of recurrence, and higher cancer-specific and all-cause mortality (number of deaths). Lifestyle factors, such as low physical activity and unhealthy diet, are the main contributors to obesity that are modifiable. Lifestyle weight loss programs focusing on modifiable factors can improve cancer-specific survival and many aspects of health, but access to these programs can be challenging in rural settings. A remote lifestyle program, adapted to individual goals and needs, may help promote healthy behaviors, improve cancer outcomes, and reduce disease burden in stage I-III postmenopausal breast and endometrial cancer survivors.",[57,27,28,304,462,463,210],"Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage II Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","2026-07-20",{"date":466,"type":35},"2026-07-23",{"date":468,"type":21},"2026-10-10",{"date":266,"type":21},{"name":268,"class":69},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":22,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":70},"100648454","phase-2-a-vaccine-stemvac-for-improving-survival-in-patients-with-triple-negative-breast-cancer-and-moderate-or-extensive-residual-cancer-burden-100648454","NCT07721259","A Vaccine (STEMVAC) for Improving Survival in Patients With Triple-Negative Breast Cancer and Moderate or Extensive Residual Cancer Burden","A Multiantigen Vaccine (STEMVAC) for Adjuvant Treatment of Patients With Moderate or Extensive Residual Triple-Negative Breast Cancer","Inclusion Criteria:\n\n* At least 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2\n* Triple-negative breast cancer as determined by the treating oncologist\n* Completed standard of care neoadjuvant chemotherapy in the opinion of their treating oncologist\n* Patients whose tumors progress on neoadjuvant therapy may be enrolled\n* No clinical evidence of local or distant recurrence\n* Plan to receive standard of care adjuvant directed therapy\n* Completed standard of care locoregional treatment, including definitive breast and lymph node surgery followed by standard radiation therapy, if recommended\n* Residual cancer burden (RCB) index 2 or 3 as calculated per routine anatomic pathology clinical standards\n* Absolute neutrophil count (ANC) ≥ 800\u002FμL (within 30 days of first study vaccine administration)\n* Hemoglobin (Hgb) ≥ 8 g\u002FdL (within 30 days of first study vaccine administration)\n* Platelets ≥ 75,000\u002F μL (within 30 days of first study vaccine administration)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome, in whom total bilirubin must be \\\u003C 3.0 mg\u002FdL (within 30 days of first study vaccine administration)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 1.5 x institutional ULN (within 30 days of first study vaccine administration)\n* Creatinine ≤ 1.5 x ULN mg\u002FdL or creatinine clearance \\> 60 mL\u002Fmin (within 30 days of first study vaccine administration)\n* At least 28 days post systemic steroids prior to enrollment, unless used as part of prophylaxis to prevent intravenous (IV) contrast reactions.\n\n  * Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed\n* Must have recovered from major infections and\u002For surgical procedures; and in the opinion of the investigator, not have any significant active concurrent medical illnesses or condition precluding protocol treatment\n* Patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a person of child-bearing potential. Acceptable methods of contraception are abstinence, condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal\n\nExclusion Criteria:\n\n* Toxicities related to prior exposure to immune checkpoint inhibitors for which immune checkpoint inhibitors cannot be safely continued as determined by study investigator\n* Germline BRCA1 or BRCA2 mutations with adjuvant olaparib planned within the study period\n\n  * NOTE: If olaparib is not planned, then these patients are eligible\n* Any known cardiac conditions:\n\n  * Symptomatic restrictive cardiomyopathy\n  * Dilated cardiomyopathy\n  * Unstable angina within 4 months prior to enrollment\n  * New York Heart Association functional class III-IV heart failure on active treatment\n  * Symptomatic pericardial effusion\n* Autoimmune disease requiring active systemic treatment\n* Known hypersensitivity reaction to the GM-CSF adjuvant; any known contra-indication to GM-CSF\n* Pregnant or breast feeding\n* Known history of human immunodeficiency virus (HIV) infection, hepatitis B (e.g., hepatitis B virus surface antigen \\[HBsAg\\] reactive), or hepatitis C (e.g., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] is detected)\n* Major surgery within the 4 weeks prior to initiation of first study vaccine\n* Enrollment in any other clinical protocol or investigational trial that involves concurrent administration of experimental therapy and\u002For therapeutic devices, or investigational drug. Patients who completed prior clinical trials (such as neoadjuvant treatment, surgery or radiation trials) and are on long term follow up are permitted",{"count":479,"type":21},60,[54],"This phase II trial evaluates whether a multi-antigen vaccine called STEMVAC improves disease-free survival after surgery in patients with triple-negative breast cancer (TNBC) and moderate or extensive residual cancer burden. TNBC has an aggressive clinical course and poorer disease-free survival compared to other subtypes. While patients who have no remaining tumor in the breast or lymph nodes after surgery have excellent long-term outcomes, patients with moderate or extensive residual cancer burden remain at high risk for early disease return and poorer prognosis. STEMVAC is designed to target proteins that tumor cells use when they become more aggressive and start to spread, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Giving STEMVAC after surgery may improve disease-free survival rates in TNBC patients with moderate or extensive residual cancer burden.",[57,27,28,195],"2026-07-17",{"date":466,"type":35},{"date":486,"type":21},"2026-09-30",{"date":488,"type":21},"2030-07-16",{"name":490,"class":69},"University of Washington",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":229,"minAge":4,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":425},"100485010","phase-2-fisetin-to-improve-physical-function-in-stage-i-iii-breast-cancer-survivors-100485010","NCT05595499","Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors","A Phase II Randomized Double-Blind Placebo-Controlled Study of Fisetin to Improve Physical Function in Breast Cancer Survivors","Inclusion Criteria:\n\n* Women who are postmenopausal at the start of study treatment.\n\nPostmenopausal status will be established as follows:\n\n* Women aged: \\>= 60 years OR\n* Women aged \\\u003C 60 years AND one of the following conditions is met:\n\n  * They have not had any menstrual periods for at least 12 months in the absence of exogenous hormonal treatments, chemotherapy, and\u002For tamoxifen AND have serum estradiol and follicle-stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for postmenopausal females.\n  * They have documented irreversible bilateral oophorectomy.\n  * They are receiving ovarian suppression with their breast cancer endocrine therapy\n\n    * Women with a diagnosis of early-stage breast cancer (Stage I-III) treated with neo\u002Fadjuvant chemotherapy within 12 months of starting study treatment\n    * No evidence of active\u002Frecurrent breast cancer or other serious chronic illnesses\n    * Have evidence of frail health, defined as a diminished 6-minute walk distance (\\\u003C 400m) at baseline\n    * Platelets \\> 60,000\u002Fmm\\^3\n    * White blood cell count \\> 2,000\u002Fmm\\^3\n    * Absolute neutrophil count \\> 500\u002Fmm\\^3\n    * Hemoglobin \\>= 8.0 g\u002FdL\n    * Total bilirubin =\\\u003C 3.0 X upper limit of normal (ULN)\n    * Aspartate aminotransferase (AST) =\\\u003C 4.0 x ULN\n    * Alanine aminotransferase (ALT) =\\\u003C 4.0 x ULN\n    * Estimated glomerular filtration rate (eGFR) of \\>= 30mL\u002Fmin\u002F1.73m\\^2 per the Modification of Diet in Renal Disease (MDRD) calculation\n    * Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days prior to the start of study treatment. Exceptions include: trastuzumab, pertuzumab, pembrolizumab, tamoxifen, ribociclib, abemaciclib, aromatase inhibitors and\u002For ovarian suppression.\n* Surgery and\u002For radiation within the last 30 days of starting study treatment (Exception: invasive non- major procedures such as an outpatient biopsy)\n* Subjects taking medications that are considered prohibited.\n\n  * Exception: Subjects taking any of the medications listed in under \"Temporary medication adjustment required\" may participate if they are otherwise eligible AND the medication can be safely withheld (from immediately before the 1st study agent administration until at least 10 hours after the last study agent administration, for each dosing interval)\n* On herbal and natural medications with possible senolytic properties (i.e., curcumin, kava kava, St. John's wort) and are unable or unwilling to hold its administration 2 days prior to and during study treatment dosing. Exceptions include cannabidiol (CBD), vitamins, probiotics, and fish oil. Other herbal and natural medications may be permitted or prohibited per clinician discretion\n* Subjects taking potentially senolytic agents within the last year: fisetin, quercetin, luteolin, dasatinib or imatinib (or other tyrosine kinase inhibitors), piperlongumine, or navitoclax\n* Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc.)\n* Issues with tolerating oral medication (such as but not limited to, inability to swallow pills (g-tubes not allowed), malabsorption issues, ongoing nausea or vomiting during screening, history of Crohn's, gastric bypass\u002Freduction, or celiac disease)\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Currently participating in another intervention research study seeking to improve functional status, alleviate frailty, muscle strength, exhaustion\u002Ffatigue, or cognitive function",{"count":499,"type":21},88,[54],"This phase II trial tests whether fisetin works to improve physical function in women who have received chemotherapy for stage I-III breast cancer treatment. Fisetin is a naturally occurring substance that is found in strawberries and other foods. Fisetin eliminates cells that have undergone a process called senescence. Senescence is when a cell ages and permanently stops dividing but does not die. Over time, large numbers of these cells build up in tissues throughout the body and can release harmful substances that causes inflammation and damages nearby healthy cells. Studies have shown that chemotherapy causes a build-up of these senescent cells. Giving fisetin may eliminate senescent cells and improve physical function in postmenopausal women who have received chemotherapy for breast cancer.",[57,27,28],"2026-07-16",{"date":483,"type":35},{"date":506,"type":35},"2023-03-27",{"date":508,"type":21},"2028-08-14",{"name":68,"class":69},{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":229,"minAge":18,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":22,"phases":519,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":530},"100474969","early-phase-1-letrozole-with-and-without-simvastatin-for-the-treatment-of-stage-i-iii-hormone-receptor-positive-her2-negative-breast-cancer-100474969","NCT05464810","Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer","A Randomized Window of Opportunity Study of Preoperative Letrozole and Simvastatin Versus Letrozole Alone in Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Biopsy proven hormone receptor positive, HER2 negative stage I-III invasive breast cancer\n\n  * Estrogen receptor (ER) and\u002For progesterone receptor (PR) positivity are defined as \\>= 10% of cells expressing hormonal receptors via IHC analysis\n  * HER2 negativity is defined as either of the following by local laboratory assessment\n\n    * IHC 0, 1+, or 2+ and in situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \\\u003C 2.0 or single probe average HER2 gene copy number \\\u003C 4 signals\u002Fcell)\n* Minimum primary tumor size 5 mm on any breast imaging (mammogram, ultrasound, magnetic resonance imaging \\[MRI\\])\n* Baseline Ki-67 IHC expression on tumor tissue \\>= 10%\n* Post-menopausal women\n\n  * Prior bilateral oophorectomy\n  * Age \\>= 55 years\n  * Age \\\u003C 55 and amenorrheic for 12 months or more in the absence of chemotherapy, endocrine therapy, or ovarian suppression and follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol in the postmenopausal range\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Prior treatment:\n\n  * No systemic therapy (chemotherapy, immunotherapy, endocrine therapy, and\u002For investigational therapy) within 3 months of trial enrollment\n* No statins, fibrates, or ezetimibe within 3 months of trial enrollment\n* No active liver disease\n* Hemoglobin \\>= 9.0 g\u002Fdl (Note: the use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 9.0 g\u002Fdl is acceptable) (within 14 days prior to initiation of study treatment)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL (after at least 7 days without growth factor support or transfusion) (within 14 days prior to initiation of study treatment)\n* Platelets \\>= 100,000\u002FmcL (within 14 days prior to initiation of study treatment)\n* Total bilirubin =\\\u003C 2 institutional upper limit of normal (ULN) (within 14 days prior to initiation of study treatment)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 institutional ULN (within 14 days prior to initiation of study treatment)\n* Serum creatinine =\\\u003C 2 mg\u002FdL (or glomerular filtration rate \\>= 40 mL\u002Fmin) (within 14 days prior to initiation of study treatment)\n* Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions\n* Be willing and able to provide written informed consent for the trial\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents or an investigational device within 3 months before administration of first dose of study drugs\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to simvastatin and\u002For letrozole\n* Concomitant use of strong CYP3A4 inhibitors (i.e. clarithromycin, erythromycin, itraconazole, ketroconazole, nefazodone, Posaconazole, voriconazole, protease inhibitors \\[including boceprevir and telaprevir\\], telithromycin, cobicistat-containing products), cyclosporine, danazol, and gemfibrozil\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, substance abuse disorders, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association class 3 or 4 congestive heart failure; or uncontrolled grade \\>= 3 hypertension (diastolic blood pressure \\>= 100 mmHg or systolic blood pressure \\>= 160 mmHg) despite antihypertensive therapy\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy",{"count":518,"type":21},40,[520],"EARLY_PHASE1","This early phase I trial tests whether letrozole with simvastatin works better than letrozole alone to stop tumor cell proliferation in patients with stage I-III hormone receptor positive, HER2 negative invasive breast cancer. Letrozole and simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The addition of simvastatin to letrozole may be more effective at stopping the growth of cancer cells than letrozole alone.",[57,27,28,29,30,58],{"date":483,"type":35},{"date":525,"type":35},"2022-09-02",{"date":527,"type":21},"2028-04-15",{"name":529,"class":69},"Emory University",4,{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":22,"phases":539,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":596,"locationsCount":70},"100446356","phase-1-phase-i-study-of-tumor-treating-fields-ttf-in-combination-with-cabozantinib-or-with-pembrolizumab-and-nab-paclitaxel-in-patients-with-advanced-solid-tumors-involving-the-abdomen-or-thorax-100446356","NCT05092373","Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax","Inclusion Criteria:\n\n* Participants must have pathologically confirmed advanced\u002Fmetastatic solid cancer (hepatocellular carcinoma, renal cell carcinoma, breast cancer, ovarian\u002Ffallopian, or endometrial\u002Fprimary peritoneal tumors) involving the abdomen or thorax, cannot tolerate standard therapy or have experienced tumor progression on standard therapy.\n* Age: ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Life expectancy \\>3 months.\n* Normal bone marrow function, defined as absolute neutrophil count ≥1,000\u002FµL; platelets ≥75,000\u002FµL; hemoglobin ≥8 g\u002FdL.\n* Adequate hepatic function as defined by a total bilirubin level ≤1.5 x the upper limit of normal (ULN), unless the patient has known Gilbert's syndrome, and alanine aminotransferase (ALT)\u002F serum glutamic pyruvic transaminase levels (SGPT) ≤2.5 x ULN (unless the patient has liver metastases: ALT)\u002F serum glutamic pyruvic transaminase levels (SGPT) ≤5 x ULN).\n* Participants with HCC must have a Child Pugh status A, no clinically significant ascites (requiring pharmacological or interventional treatment), and no history (or increased risk) of esophageal\u002Fgastric bleeding, impaired wound healing, perforation or fistula.\n* Serum creatinine clearance ≥50 mL\u002Fmin by the Cockcroft-Gault formula.\n* Measurable disease by RECIST or evaluable disease.\n* Contraception: Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months and who have not had a tubal ligation, hysterectomy, or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. Male participants must agree to use effective contraception or abstinence while on study.\n* Able to operate the TTF device independently or with the help of a caregiver.\n\nExclusion Criteria:\n\n* Participants must not receive prior anticancer therapy or radiation therapy within 2 weeks and must not undergo major surgery within 4 weeks prior to initiation of treatment on protocol. Participants who are already on cabozantinib and have progressive disease are allowed to transition to treatment with tumor treating fields and cabozantinib. Participants in both cohorts who already started treatments as standard of care (Cohort 1: Cabozantinib and Cohort 2: nab-paclitaxel and Pembrolizumab) are allowed to start on protocol within the first 2-3 weeks of treatment initiation. Palliative radiation therapy is allowed.\n* Participants must have recovered to Grade 0-1 toxicity from prior therapy.\n* Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by brain imaging for at least 4 weeks and the patient must have been off steroids for at least 2 weeks.\n* The patient has cardiac conditions as follows: uncontrolled: hypertension (blood pressure \\[BP\\] \\> 160\u002F100) despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure (New York Heart Association Class II or above), prior or current cardiomyopathy, uncontrolled atrial fibrillation with heart rate \\> 100 beats per minute (bpm), unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly).\n* The patient has concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).\n* Concurrent malignancies are permitted if (A) they were previously treated, and all treatment of that malignancy was completed at least 2 years before enrollment and no evidence of disease exists, or (B) with agreement from the Principal Investigator (PI), participants who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are eligible to participate if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low, or (C) with agreement from the PI, other malignancies may be permitted if the risk of the prior malignancy interfering with either safety or efficacy end points is very low. Adequately treated basal or squamous cell carcinoma or carcinoma in situ is allowed.\n* The patient is pregnant or breastfeeding.\n* History of hypersensitivity or contraindication to TTF.\n* Implanted pacemaker, defibrillator or other electrical medical devices.\n* The participant has a previously-identified allergy or hypersensitivity to cabozantinib, nab-paclitaxel, or pembrolizumab, medical adhesives or hydrogel or the patient has received prior cabozantinib and discontinued therapy due to unacceptable toxicity.\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n* The patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.\n* CABOZANTINIB COHORT ONLY: The patient has experienced clinically-significant hematemesis or hemoptysis of \\> 0.5 teaspoon of red blood, or other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment.\n* CABOZANTINIB COHORT ONLY: The patient has a cavitating pulmonary lesion(s) or a pulmonary lesion abutting or encasing a major blood vessel.\n* CABOZANTINIB COHORT ONLY: The patient has received drugs used to control loss of bone mass within 4 weeks prior to the first dose of study treatment.\n* CABOZANTINIB COHORT ONLY: The patient has prothrombin time\u002Finternational normalized ratio (PT\u002FINR) or partial thromboplastin time (PTT) test results that are above (1.3X) the laboratory upper limit of normal.\n* CABOZANTINIB COHORT ONLY: The subject has a corrected QT interval (QTcF) \\> 450 ms for men or \\> 470 ms for women.\n* CABOZANTINIB COHORT ONLY: The patient requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or Coumadin-related agents, heparin, thrombin or FXa inhibitors, and antiplatelet agents. Low-dose aspirin (≤ 81 mg\u002Fday), low dose warfarin (≤ 1mg\u002Fday), and prophylactic low molecular weight heparin (LMWH) are permitted.\n* CABOZANTINIB COHORT ONLY: Patients with encasement of a major artery or bowel by tumor are excluded.\n* CABOZANTINIB COHORT ONLY: The patient is unable to swallow capsules.\n* CABOZANTINIB COHORT ONLY: History of hypersensitivity or contraindication to cabozantinib.\n* ATEZOLIZUMAB-CONTAINING COHORT: Participants who have received prior immunotherapy, including prior anti-PD-1 or anti-PD-L1 therapies may participate: (A) only if their prior anti-PD-1 or anti-PDL1 monotherapy or combination therapy were NOT the last treatment prior to participation on this study. (B) Participants who had prior immunotherapies and experienced Grade 1-2 immune-related adverse event (irAE) must have documentation that their irAEs are Grade 1 or 0 using current Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0) and participants must be off steroid therapy and\u002For other immunosuppressive therapy, as treatment for irAEs, for \\>= 14 days from Cycle 1, Day 1. (C) Participants who experienced Grade 3 irAEs consisting of laboratory abnormalities that were asymptomatic and have now resolved to Grade 1 or 0 and participants who have been off steroid and\u002For other immunosuppressive therapy, as treatment for irAEs, for \\>= 30 days from Cycle 1, Day 1. Participants with prior irAE pneumonitis (\\>= Grade 2) should not be given atezolizumab.\n* ATEZOLIZUMAB-CONTAINING COHORT: Human immunodeficiency virus (HIV) infection, active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics.\n* ATEZOLIZUMAB-CONTAINING COHORT: Has received a live vaccine within 30 days prior to first dose.\n* ATEZOLIZUMAB-CONTAINING COHORT: Active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.\n* ATEZOLIZUMAB-CONTAINING COHORT: Serious autoimmune disease at the discretion of the treating attending: Patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g. Wegener's Granulomatosis) are excluded from this study.\n* ATEZOLIZUMAB-CONTAINING COHORT: History of\u002For current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician.",{"count":538,"type":21},43,[116],"This phase Ib trial tests the safety, side effects, and best dose of tumor treating fields therapy in combination with either cabozantinib or nab-paclitaxel and atezolizumab in treating patients with solid tumors involving the abdomen or thorax that have spread to other parts of the body (advanced). Tumor treating fields therapy on this study utilizes NovoTTF systems that are wearable devices that use electrical fields at different frequencies that may help stop the growth of tumor cells by interrupting cancer cells' ability to divide. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tumor treating fields therapy in combination with either cabozantinib, or with nab-paclitaxel and atezolizumab may help control advanced solid tumors involving the abdomen or thorax.",[542,543,544,545,546,547,548,549,550,551,28,119,120,121,84,552,553,413,153,554,157,555,556,557,558,559,161,560,561,562,563,564,565,167,566,567,169,568,569,171,570,571,173,572,573,574,575,576,175,577,578,177,579,580,581,179,180,181,582,184,583,584,186,585,586,188,587,588,190,589,192,590,591,194],"Advanced Breast Carcinoma","Advanced Endometrial Carcinoma","Advanced Fallopian Tube Carcinoma","Advanced Hepatocellular Carcinoma","Advanced Malignant Abdominal Neoplasm","Advanced Malignant Female Reproductive System Neoplasm","Advanced Malignant Thoracic Neoplasm","Advanced Ovarian Carcinoma","Advanced Primary Peritoneal Carcinoma","Advanced Renal Cell Carcinoma","Malignant Abdominal Neoplasm","Malignant Solid Neoplasm","Metastatic Fallopian Tube Carcinoma","Metastatic Malignant Abdominal Neoplasm","Metastatic Malignant Female Reproductive System Neoplasm","Metastatic Malignant Thoracic Neoplasm","Metastatic Ovarian Carcinoma","Metastatic Primary Peritoneal Carcinoma","Prognostic Stage III Breast Cancer AJCC v8","Prognostic Stage IIIA Breast Cancer AJCC v8","Prognostic Stage IIIB Breast Cancer AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Prognostic Stage IV Breast Cancer AJCC v8","Stage III Fallopian Tube Cancer AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Primary Peritoneal Cancer AJCC v8","Stage III Uterine Corpus Cancer AJCC v8","Stage IIIA Fallopian Tube Cancer AJCC v8","Stage IIIA Ovarian Cancer AJCC v8","Stage IIIA Primary Peritoneal Cancer AJCC v8","Stage IIIA1 Fallopian Tube Cancer AJCC v8","Stage IIIA1 Ovarian Cancer AJCC v8","Stage IIIA2 Fallopian Tube Cancer AJCC v8","Stage IIIA2 Ovarian Cancer AJCC v8","Stage IIIB Fallopian Tube Cancer AJCC v8","Stage IIIB Ovarian Cancer AJCC v8","Stage IIIB Primary Peritoneal Cancer AJCC v8","Stage IIIC Fallopian Tube Cancer AJCC v8","Stage IIIC Ovarian Cancer AJCC v8","Stage IIIC Primary Peritoneal Cancer AJCC v8","Stage IV Fallopian Tube Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Primary Peritoneal Cancer AJCC v8","Stage IV Uterine Corpus Cancer AJCC v8","Stage IVA Fallopian Tube Cancer AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVA Primary Peritoneal Cancer AJCC v8","Stage IVB Fallopian Tube Cancer AJCC v8","Stage IVB Ovarian Cancer AJCC v8","Stage IVB Primary Peritoneal Cancer AJCC v8",{"date":503,"type":35},{"date":594,"type":35},"2022-04-29",{"date":243,"type":21},{"name":597,"class":69},"M.D. Anderson Cancer Center",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":22,"phases":607,"briefSummary":608,"conditions":609,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":624},"100603507","phase-1-testing-the-safety-of-the-combination-of-anti-cancer-drugs-cx-5461-pidnarulex-and-trastuzumab-deruxtecan-t-dxd-for-human-epidermal-growth-factor-receptor-2-her2-positive-solid-tumors-and-breast-cancer-100603507","NCT07137416","Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer","Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors","Inclusion Criteria:\n\n* DOSE ESCALATION PHASE ONLY: Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective\n* DOSE EXPANSION PHASE ONLY: Participants must have histologically or cytologically confirmed invasive breast cancer, with either locally advanced or metastatic disease\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of CX-5461 (pidnarulex) in combination with T-DXd in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL\n\n  * No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 1 week prior to screening assessment\n* Platelets ≥ 100,000\u002FmcL\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (or ≤ 2 × institutional ULN in patients with documented Gilbert's syndrome)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 × institutional ULN (or ≤ 5 × ULN in patients with liver metastases)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 (using the Cockcroft-Gault equation for participants with creatinine levels above institutional ULN)\n* Patients must have had at least one prior line of cytotoxic chemotherapy. Patients can have received an unlimited number of additional lines of chemotherapy, targeted therapy, biologic therapy, or hormonal therapy. Patients must not have progressed on a prior anthracycline in the metastatic setting. Receipt of anthracycline in the (neo)adjuvant setting is allowed, provided that disease recurrence occurred later than 6 months after the completion of treatment\n* Prior poly (ADP-ribose) polymerase (PARP) inhibition is allowed\n* No specific germline mutation is required\n* DOSE ESCALATION PHASE ONLY:\n\n  * HER2-positive (IHC 3+) solid cancers,\n  * HR+ HER2 positive\u002Flow\u002Fultralow breast cancer or triple negative breast cancer (TNBC) HER2-low breast cancer, with HER2 positive defined by the current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines,\n  * HER2-low, with HER2-low defined as IHC 2+\u002Fin situ hybridization (ISH)-, IHC 1+\u002FISH-, or IHC 1+\u002FISH untested\n* DOSE EXPANSION PHASE ONLY:\n\n  * Either the primary invasive tumor and\u002For the metastasis must be:\n\n    * HER2-low, with HER2-low defined as IHC 2+\u002FISH-, IHC 1+\u002FISH-, or IHC 1+\u002FISH untested. Any estrogen receptor (ER) and progesterone receptor (PR) expression is permitted but must be known, or\n    * HR+ HER2-ultralow defined as IHC 0 with membrane staining\n* Participants must have at least one lesion that is not within a previously radiated field that is measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Bone lesions are not considered measurable by definition. Biopsy of the lesion that will be used for disease evaluation (measurable disease) is not allowed in the dose expansion portion of this study\n* Peripheral neuropathy grade ≤ 1\n* Patients must have left ventricular ejection fraction (LVEF) ≥ 50% by either an echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within 28 days before randomization\u002Fenrollment\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* The effects of CX-5461 (pidnarulex) and T-DXd on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) 14 days prior to study entry and for the duration of study participation and for at least 7 months (women of childbearing potential \\[WOCBP\\] only) after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women should not breastfeed while taking CX-5461 (pidnarulex) and T-DXd and for 7 months after cessation of treatment. Men treated or enrolled on this protocol must also agree to use adequate contraception 14 days prior to the study, for the duration of study participation, and 6 months after completion of CX-5461 (pidnarulex) and T-DXd administration\n* Women of non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \\[FSH\\] \\> 40 mIU\u002FmL and estradiol \\\u003C 40 pg\u002FmL \\[\\\u003C 147 pmol\u002FL\\] is confirmatory) or on ovarian suppression are eligible. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method\n* Male patients must not freeze or donate sperm starting at screening and throughout the study period, and at least 6 months after the final study drug administration. Preservation of sperm should be considered prior to enrollment in this study\n* Female patients must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives (LAR) may sign and give informed consent on behalf of study participants\n* Patients who have had chest radiation therapy within 4 weeks (2 weeks for palliative stereotactic radiation therapy). These patients will be excluded because T-DXd is known to increase the risk of developing pneumonitis\n\nExclusion Criteria:\n\n* Patients with a history of (non-infectious) interstitial lung disease (ILD) that required steroids, have current ILD, or where there is suspected ILD that cannot be ruled out by imaging at screening. These patients will be excluded because T-DXd is known to increase the risk of developing ILD and pneumonitis\n* Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (i.e., Rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy at the time of screening. These patients will be excluded because T-DXd is known to increase the risk of developing ILD and pneumonitis\n* Patients who have had chemotherapy (including antibody drug therapy, retinoid therapy, hormonal therapy for cancer) within 3 weeks (2 weeks or five half-lives, whichever is longer for small-molecule targeted agents such as 5-fluorouracil-based agents, folinate agents), weekly paclitaxel; 6 weeks for nitrosoureas or mitomycin C. These patients will be excluded to allow for recovery of toxicities related to chemotherapy and minimize risk of drug interactions\n* Patients who have had cancer immunotherapy including monoclonal antibody therapy within 4 weeks\n* Patients who have had a major surgery within 4 weeks\n* Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤ 1 or baseline. Patients with chronic grade 2 toxicities may be eligible (e.g., grade 2 chemotherapy-induced neuropathy). Patients should no longer be symptomatic nor require treatment with corticosteroids or anticonvulsants and must have recovered from the acute toxic effect of radiotherapy\n* Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity of CX-5461 (pidnarulex) will be determined based on their potential to interact with the CYP3A4 isozyme. Specifically, subjects taking strong CYP3A4 inhibitors or strong CYP3A4 inducers will be excluded from participation in the trial. A list of agents that interact with CYP450 isoenzymes is provided\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CX-5461 (pidnarulex), T-DXd, or the inactive ingredients in the drug products, including patients who have a history of severe hypersensitivity reactions to other monoclonal antibodies\n* Patients with a corrected QT interval (QTc) prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)\n* Patients with clinically significant corneal disease, cicatricial conjunctivitis or active ocular surface disease in the opinion of the investigator\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because CX-5461 (pidnarulex) and T-DXd are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with CX-5461 (pidnarulex) and T-DXd, breastfeeding should be discontinued if the mother is treated with CX-5461 (pidnarulex) and T-DXd and avoided for 7 months after the last dose",{"count":606,"type":21},36,[116],"This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving pidnarulex in combination with trastuzumab deruxtecan may be safe, tolerable and\u002For effective in treating patients with metastatic, unresectable, or locally advanced HER2-expressing breast cancer or other solid tumors.",[28,84,58,374,413,610,611,612,88,163,415,613,614,615,96,207],"Metastatic HER2-Low Breast Carcinoma","Metastatic HER2-Positive Breast Carcinoma","Metastatic Hormone Receptor-Positive Breast Carcinoma","Unresectable HER2-Low Breast Carcinoma","Unresectable HER2-Positive Breast Carcinoma","Unresectable Hormone Receptor-Positive Breast Carcinoma","2026-07-10",{"date":618,"type":35},"2026-07-13",{"date":620,"type":21},"2026-10-05",{"date":622,"type":21},"2028-01-10",{"name":41,"class":42},2,{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":229,"minAge":18,"maxAge":632,"enrollmentInfo":633,"targetDuration":4,"studyType":22,"phases":635,"briefSummary":636,"conditions":637,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":70},"100628370","phase-2-evaluation-of-alternative-site-goserelin-acetate-injection-for-ovarian-function-suppression-ofs-in-local-and-locally-advanced-premenopausal-hormone-receptor-positive-breast-cancer-patients-100628370","NCT07460752","Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer Patients","MC250301, OptiOFS: A Randomized Phase II Trial of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Breast Cancer","Inclusion Criteria:\n\n* REGISTRATION (STEP 1): Age ≥ 18 years and ˂ 50 years\n* REGISTRATION (STEP 1): Have histologically or cytologically confirmed, localized or locally advanced hormone positive breast cancer stage I-III (defined as ER Immunohistochemistry (IHC) \\> 1%\\] having completed curative intent therapy and clinically in remission\n* REGISTRATION (STEP 1): Currently receiving ovarian function suppression (OFS) with use of goserelin on a monthly basis in the abdomen and either aromatase inhibitor or tamoxifen for at least 6 months prior to study enrollment for treatment of hormone receptor positive breast cancer with plan to continue medical OFS for at least the next 12 months\n* REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* REGISTRATION (STEP 1): Provide written informed consent\n* REGISTRATION (STEP 1): Ability to complete questionnaire(s) by themselves or with assistance\n* REGISTRATION (STEP 1): Willingness to provide mandatory blood specimens for correlative research\n* REGISTRATION (STEP 1): Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* REGISTRATION (STEP 1): Negative serum pregnancy test =\\\u003C 14 days prior to registration, and a negative urine pregnancy test =\\\u003C 7 days prior to randomization\n* REGISTRATION (STEP 1): Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 3 months after the last dose of study drug.\n\n  * Note: The following are considered effective contraceptives: oral contraceptive pill; condom plus spermicide; diaphragm plus spermicide; patient or partner surgically sterile; patient or partner more than 12 months postmenopausal; or injectable or implantable agent\u002Fdevice. Male patients should refrain from sperm donation and female patients should refrain from breastfeeding throughout this period\n* RANDOMIZATION (STEP 2): Completion of the lead-in treatment of 6 cycles of ovarian function suppression (OFS) with use of goserelin, with estradiol E2 value of ˂ 20 pg\u002FmL and no back to back E2 levels \\> 10 pg\u002FmL after cycle 6 blood draw\n\nExclusion Criteria:\n\n* REGISTRATION (STEP 1): Any of the following prior therapies: Chemotherapy =\\\u003C 6 months prior to registration. NOTE: concurrent receipt of human epidermal growth factor receptor 2 (HER2) directed antibodies or antibody-drug conjugates, endocrine therapy, or cyclin-dependent kinase (CDK) 4\u002F6 inhibitor is permitted\n* REGISTRATION (STEP 1): Receiving any estrogen or progestin containing medications, including topical estrogens\n* REGISTRATION (STEP 1): Planning to temporarily or permanently discontinue medical OFS in the next 12 months","50 Years",{"count":634,"type":21},98,[54],"This phase II trial determines if giving goserelin acetate injections in the upper gluteal region is as effective for ovarian function suppression (OFS) as giving injections in the abdomen for ovarian function suppression (OFS) in premenopausal patients with hormone receptor positive breast cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Goserelin acetate is a drug used to treat prostate cancer, relieve the symptoms of advanced breast cancer, and treat problems with the endometrium (lining of the uterus). Goserelin acetate initially causes the pituitary gland to make more luteinizing hormone (LH) and follicle-stimulating hormone (FSH), temporarily increasing testosterone levels in men and estrogen levels in women. With continued use, goserelin acetate lowers the amount of LH and FSH the pituitary gland releases, leading to a drop in testosterone levels in men and estrogen levels in women. Goserelin acetate may stop the growth of cancer cells that need testosterone or estrogen to grow. It is a type of hormone therapy called a luteinizing hormone-releasing hormone (LHRH) agonist. Giving goserelin acetate injections in the upper gluteal region may be as effective for OFS as giving injections in the abdomen for OFS in premenopausal patients with localized or locally advanced hormone receptor positive breast cancer.",[57,27,28,638],"Locally Advanced Hormone Receptor-Positive Breast Carcinoma","2026-07-06",{"date":641,"type":35},"2026-07-08",{"date":643,"type":35},"2026-05-22",{"date":645,"type":21},"2029-09-26",{"name":221,"class":69},{"id":648,"slug":649,"hasResults":12,"nctId":650,"briefTitle":651,"officialTitle":652,"acronym":4,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":229,"minAge":18,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":22,"phases":655,"briefSummary":656,"conditions":657,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":624},"100491336","feasibility-study-of-biobehavioral-stress-reduction-intervention-in-patients-with-triple-negative-breast-cancer-100491336","NCT05677802","Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer","Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients","Inclusion Criteria:\n\n* Age \\>=18 years\n* Untreated newly diagnosed triple negative breast cancer\n* Stages I-III\n\nExclusion Criteria:\n\n* Prisoners\n* Male\n* Identifying as American Indian, Alaska Native, Asian, Native Hawaiian or Other Pacific Islander\n* Individuals not able to speak and understand English\n* Known personal history of ductal carcinoma in situ (DCIS) or invasive breast cancer\n* Stage IV breast cancer",{"count":518,"type":21},[257],"This clinical trial aims to see if patients with triple negative breast cancer can complete a biobehavioral stress reduction program that also addresses health related social needs (e.g., utilities, transportation, etc.). The stress reduction program is over ten weeks and includes stress reduction (e.g., progressive muscle relaxation), coping, problem solving, communication, and social support. Health related social needs will be evaluated at the beginning of the study, and referrals will be made to social work to help address those needs. The study will examine stress as reported by the patients and also use biological markers.",[57,27,28,29,658,195],"Hormone Receptor-Negative Breast Carcinoma","2026-06-24",{"date":661,"type":35},"2026-06-29",{"date":663,"type":35},"2022-12-14",{"date":665,"type":21},"2027-06-30",{"name":268,"class":69},{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":4,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":229,"minAge":18,"maxAge":4,"enrollmentInfo":674,"targetDuration":4,"studyType":22,"phases":676,"briefSummary":677,"conditions":678,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":679,"lastUpdatePostDateStruct":680,"startDateStruct":682,"completionDateStruct":684,"leadSponsor":686,"locationsCount":70},"100605092","phase-2-leuprolide-and-goserelin-for-ovarian-function-suppression-in-pre--or-peri-menopausal-women-with-breast-cancer-ofs-trial-100605092","NCT07158021","Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial","Phase 2 Interventional Trial of Ovarian Function Suppression for Breast Cancer (OFS)","Inclusion Criteria:\n\n* Female subject aged ≥ 18 years\n* Pre- or peri-menopausal patient, who had (1) menses either within the 12 months prior to or since breast cancer diagnosis or (2) estradiol concentration above the postmenopausal range per institutional laboratory guidance either within the 12 months prior to or since breast cancer diagnosis.\n* Planning to take GnRHa therapy in combination with oral endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment of stage 1-3 breast cancer or for treatment of metastatic breast cancer. Prior treatment with GnRHa therapy for treatment of non-oncologic conditions or during chemotherapy is permitted.\n* Not planning bilateral salpingo-oophorectomy during the 6-month study duration\n* Completion of chemotherapy, if given. Concurrent use of trastuzumab, pertuzumab, bisphosphonate therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy, cyclin D kinase 4\u002F6 (CDK4\u002F6) inhibitor, and\u002For phosphoinositide 3-kinase (PI3K) inhibitor therapy is permitted\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines\n\nExclusion Criteria:\n\n* Prior bilateral salpingo-oophorectomy\n* Known to be pregnant or breastfeeding (negative pregnancy test will be confirmed prior to study treatment initiation)\n* Concomitant use of systemic or transdermal estrogen products\n* Known allergy or hypersensitivity to goserelin or leuprolide, or any of the excipients in the medications\n* Unable to take oral medications\n* Any medical condition that would interfere with the absorption of endocrine therapy. Prior gastric bypass is permitted\n* Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen",{"count":675,"type":21},75,[54],"This phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells. Both leuprolide and goserelin lower the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. This study compares lower dose leuprolide, higher dose leuprolide, and goserelin for their ability to suppress the function of the ovaries to produce estrogen. Both doses of leuprolide may be as safe, tolerable and\u002For effective as goserelin in suppressing ovarian function in pre- or peri-menopausal women with breast cancer.",[57,27,28,84,413],"2026-06-18",{"date":681,"type":35},"2026-06-23",{"date":683,"type":35},"2026-01-22",{"date":685,"type":21},"2028-01-01",{"name":687,"class":69},"University of Michigan Rogel Cancer Center",{"id":689,"slug":690,"hasResults":12,"nctId":691,"briefTitle":692,"officialTitle":693,"acronym":4,"eligibilityCriteria":694,"healthyVolunteers":12,"sex":229,"minAge":18,"maxAge":4,"enrollmentInfo":695,"targetDuration":4,"studyType":22,"phases":697,"briefSummary":698,"conditions":699,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":700,"lastUpdatePostDateStruct":701,"startDateStruct":702,"completionDateStruct":704,"leadSponsor":706,"locationsCount":70},"100510749","remotely-delivered-community-aligned-weight-loss-interventions-among-breast-cancer-survivors-vida-trial-100510749","NCT05930483","Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial","Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study","Inclusion Criteria:\n\n* Biologically female\n* Age \\>= 18 years\n* Self-identifies Hispanic\u002FLatina\n* Able to read and write in Spanish and\u002For English\n* Previous diagnosis of stage I-III BC within the past 5 years\n* No evidence of current, recurrent, or metastatic disease\n* 60 days post treatment, including chemotherapy, radiation therapy, and cancer-related surgery (NOTE: current allowed therapies include endocrine therapy, CDK4\u002F6 inhibitors (e.g. palbociclib,ribociclib, abemaciclib), HER2-directed therapies (e.g., trastuzumab, neratinib), and monoclonal antibodies (e.g., pertuzumab, pembrolizumab); surgery for breast reconstruction is allowed during the trial)\n* Body mass index (BMI) \\>= 27 kg\u002Fm\\^2 initially assessed via self-reported height and weight and confirmed prior to randomization via a tape measure and Bluetooth-enabled scale\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Willingness to participate in all study activities\n* Access to phone for study contacts\n* Access to internet to participate in the online program and to be able to sync study devices\n* Successful completion of at-home baseline assessments prior to randomization\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\\u003C 27 kg\u002Fm\\^2 at time of baseline data collection\n* Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed)\n* Use of glucagon-like peptide-1 (GLP1) receptor agonist medications reported at baseline\n* Current use of cytotoxic chemotherapy medications (e.g., capecitabine) or drug-antibody conjugates (e.g., trastuzumab emtansine \\[T-DM1\\], trastuzumab deruxtecan \\[T-DXd\\])\n* Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA\n* Pregnant, breastfeeding, or planning to become pregnant during the study period\n* Use of exogenous hormones for gender affirmation\n* For stool sample collection only: Self-reported use of oral or intravenous antibiotics, antifungals, or anti-parasitics during the past 6 months\n* For stool sample collection only: Presence of self-reported ileostomy or colostomy\n* For stool sample collection only: Presence of self-reported inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis)\n* Anticipated major surgical procedure (e.g., hysterectomy) within 3 months after study registration. Breast reconstruction is allowed during study participation.\n* Concurrent enrollment in another weight loss or physical activity trial",{"count":696,"type":21},640,[257],"This clinical trial evaluates remotely delivered, community-aligned weight loss interventions in Latina breast cancer survivors. Breast cancer is the second leading cause of cancer death among women in the US. There are population differences in breast cancer mortality, based on specific risk factors, including obesity. Cancer is the leading cause of death among Latinos, and among Latinas, breast cancer is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight\u002Fobesity, which is associated with poorer breast cancer outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina breast cancer survivors. The development of an adaptive program that provides survivors with the support they need, as opposed to what is typically available, to improve breast cancer survivorship.",[57,27,28],"2026-06-16",{"date":679,"type":35},{"date":703,"type":35},"2025-04-08",{"date":705,"type":21},"2028-03-01",{"name":399,"class":69},{"id":708,"slug":709,"hasResults":12,"nctId":710,"briefTitle":711,"officialTitle":712,"acronym":713,"eligibilityCriteria":714,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":715,"enrollmentInfo":716,"targetDuration":4,"studyType":22,"phases":718,"briefSummary":719,"conditions":720,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":723,"lastUpdatePostDateStruct":724,"startDateStruct":726,"completionDateStruct":728,"leadSponsor":730,"locationsCount":624},"100629393","personalized-exercise-program-for-survivors-of-breast-cancer-steps-bc-trial-100629393","NCT07474090","Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial","Supportive Tailored Exercise Program for Survivors of Breast Cancer (STEPS-BC)","STEPS-BC","Inclusion Criteria:\n\n* Stage I-III breast cancer (including inflammatory and newly diagnosed, or locally recurrent \\[if prior treatment received ≥ 2 years prior\\] but not metastatic breast cancer being treated with curative intent). All molecular subtypes (estrogen receptor \\[ER\\], progesterone receptor \\[PR\\], human epidermal growth factor receptor 2 \\[HER2\\], etc.) are acceptable\n* Scheduled to receive neoadjuvant or adjuvant cytotoxic chemotherapy. Patient must be enrolled ≤ 3 weeks from start of cytotoxic chemotherapy\n* Age 18 to 85 years at enrollment. The upper age cut-off is due to the increased risk of injury in the older population during the CPET, which uses stationary bicycle exercise testing, outweighing the benefit of including this age group\n* Must be able to complete a stationary bicycle exercise test where you pedal against some resistance on a stationary bike with supervisors at your side per patient self-report\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting per patient self-report\n* Able to hold breath for 8 seconds\n* Must be able to read and understand English language\n* Must have access to a device that allows teleconferencing (e.g., Zoom calls) or be willing to participate in the Tablet Lending Program\n* Must be willing to download and use the Trainerize application to their personal device or be willing to participate in the Tablet Lending Program\n* Must have a working email address to participate in teleconferencing (e.g., Zoom calls). Local National Cancer Institute Community Oncology Research Program (NCORP) site staff may assist in setting up a new email address, if needed\n\nExclusion Criteria:\n\n* At enrollment, the following diagnosis and\u002For conditions may not be present (i.e., documented in the medical record or by patient self-report):\n\n  * Symptomatic claustrophobia\n  * Pregnancy or breast-feeding\n  * Ferromagnetic cerebral aneurysm clips or other intraorbital\u002Fintracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices, such as tissue expanders\n  * Uncontrolled hypertension (systolic blood pressure \\> 190 mm Hg or diastolic blood pressure \\> 100 mm Hg)\n  * Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion, as determined by the treating physician\n  * Significant ventricular arrhythmias (\\> 20 premature ventricular contractions \\[PVCs\\]\u002Fmin)\n  * Atrial fibrillation with uncontrolled ventricular response (\\> 130 beats per minute \\[bpm\\])\n  * Unstable or stable angina (cardiac chest pain)\n  * Severe pulmonary hypertension\n  * Left main coronary artery disease\n  * Symptomatic heart failure\n  * Severe valvular heart disease\n  * Aortic aneurysm (\\> 45 mm diameter) or aortic dissection\n  * Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise\n  * Hypertrophic obstructive cardiomyopathy\n* Acute myocardial infarction within 28 days of enrollment\n* Acute pulmonary embolus and\u002For deep vein thrombosis within 24 weeks prior to enrollment\n* Plans to relocate within 6 months of enrollment and unable to participate in study procedures\n* May not be on a simultaneous interventional supportive care (non-therapeutic) clinical trial\n* May not be undergoing simultaneous treatment for a concurrent second primary cancer (patients with historical cancer will not be excluded if chemotherapy was received ≥ 2 years prior)\n* May not be currently engaged in ≥ 300 minutes of moderate to vigorous intensity physical activity per week as determined by self-report on the International Physical Activity Questionnaire -Short Form (IPAQ-SF). Site should use the IPAQ-SF screener in the REDCap WF-2401 STEPS-BC screening project to assist in this determination","85 Years",{"count":717,"type":21},120,[257],"This clinical trial studies whether a healthy living intervention (HLI), with or without a physical activity intervention (PAI), helps maintain the ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment. Early detection and enhanced therapies for breast cancer have improved 5-year cancer-related survival rates. Unfortunately, many breast cancer survivors are at high risk for long-term exercise intolerance, decreased heart health, and lower quality of life following chemotherapy. Currently, there are no effective therapies to help patients maintain these areas throughout chemotherapy. The HLI in this study includes virtual health education classes, which provide useful information on topics like proper nutrition, managing stress, and sleep practices. This may help patients understand the importance of living a healthy lifestyle during chemotherapy. The PAI in this study consists of virtual exercise sessions personalized to the needs of the patient, which may make it easier for patients to stay active during chemotherapy. HLI with PAI may be a more effective way to help maintain ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment.",[57,27,28,302,721,722],"Breast Inflammatory Carcinoma","Locally Recurrent Breast Carcinoma","2026-06-12",{"date":725,"type":35},"2026-06-15",{"date":727,"type":35},"2026-05-27",{"date":729,"type":21},"2030-04-30",{"name":731,"class":69},"Wake Forest University Health Sciences"]