[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,90,0,25,[9,48,73,99,123,150,169,198,226,245,266,303,332,353,377,415,438,471,490,508,529,555,575,600,619],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100638410","collection-of-csf-samples-from-participants-with-metastatic-triple-negative-breast-cancer-tnbc-and-her2-breast-cancer-with-no-prior-history-nor-active-radiographically-detectable-brain-metastases-100638410",false,"NCT07619534","Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases","Sample Collection Study to Analyze Cerebral Spinal Fluid as a Biomarker for Brain Metastasis in Metastatic Breast Cancer","* INCLUSION CRITERIA:\n* Pathology documentation of histologically confirmed HER2+ BC or TNBC with a history of metastatic disease.\n* Participants must be able to undergo lumbar puncture (LP) and brain MRI.\n* Women age \\>= 18 years\n* Adequate organ function as defined below:\n\n  * Creatinine \\\u003C=1.5 x institutional upper limit of normal (ULN)\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for individuals with creatinine levels above institutional ULN (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n\\- Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior history or current MRI-detected brain metastasis or leptomeningeal disease\n* Previous history of any invasive malignancies, except for surgically resected local cutaneous malignancies.\n* Pregnancy","ALL","18 Years","120 Years",{"count":21,"type":22},139,"ESTIMATED","OBSERVATIONAL","Background:\n\nBreast cancer is the most common cancer among women. It can often spread to the liver, lungs, bones, or brain. Breast cancer that spreads to the brain is often fatal. Researchers want to know if tumor DNA found in spinal fluid, blood, or tumor tissue can help predict when the cancer will spread to the brain. They want to collect these fluid and tissue samples for research.\n\nObjective:\n\nTo collect spinal fluid and other samples from people with breast cancer that has spread to other parts of the body.\n\nEligibility:\n\nPeople aged 18 years and older with HER2-positive or triple negative breast cancer. The cancer must have spread to other parts of the body but not to the brain.\n\nDesign:\n\nParticipants will be screened. They will have blood tests to assess kidney function. They will have an imaging scan of the brain.\n\nParticipants will come to the NIH clinic to have their samples collected:\n\n* Spinal fluid. A thin needle will be inserted into the lower back to draw out a sample of fluid from the space around the spinal cord. A physical exam and blood tests will be done to make sure it is safe for participants to have this procedure.\n* Blood.\n* Saliva or cheek swabs. They will rub a cotton swab inside of their mouth.\n* Tumor samples. If participants have had samples of tumor tissue (biopsies) collected in the past, leftover tissue may be used for this study.\n\nParticipants will be contacted for follow-up every 6 months for 3 years. They may return once a year to provide further samples.",[26,27,28,29],"Breast Cancer","Breast Carcinoma","Cancer of the Breast","Malignant Neoplasm of Breast",[31,32,33,34],"Triple Negative Breast Cancer (TNBC)","HER2-Postitive","Metastatic Breast Cancer","Cerebral Spinal Fluid Collection","NOT_YET_RECRUITING","2026-08-20",{"date":38,"type":39},"2026-08-21","ACTUAL",{"date":41,"type":22},"2026-08-26",{"date":43,"type":22},"2034-07-01",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100598103","a-synthetic-lethality-focused-algorithm-to-identify-therapeutic-options-in-advanced-metastatic-breast-cancer-synthesis-breast-100598103","NCT07067138","A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)","An Exploratory Study Using a Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)","-INCLUSION CRITERIA:\n\n1. Participants must have a histologically confirmed diagnosis of metastatic breast cancer. Note: Pathology testing outside NIH will be accepted for eligibility purposes.\n2. Participant tumor subtypes will be enrolled as follows:\n\n   * TNBC Cohort: TNBC will be defined as ER \\\u003C 10% or PR \\\u003C 10% by immunohistochemistry (IHC).\n   * Endocrine-Refractory Cohort: HR+ (ER+ and\u002For PR+) will be defined as ER \\>= 10% or PR \\>= 10% by IHC.\n   * For both cohorts, HER2 will be considered negative if not amplified as per ASCOCAP guidelines per IHC\u002FFISH. Note: HER2-low status will be regarded in accordance with NCCN guidelines (in which this designation serves as a predictive marker for trastuzumab deruxtecan, but participants are otherwise not considered eligible for other HER2-directed therapies).\n3. Participants must have been treated with at least one (1) line of systemic therapy after diagnosis of metastatic disease, anticipate or have progressive disease or adverse events requiring discontinuation of their current regimen, and must not be able to transition to another approved systemic therapy shown to improve overall survival.\n\n   -Participants with HR+ disease must be deemed refractory to endocrine therapy per their clinical team, with concordance by study team.\n\n   Note: Participants who cannot receive or decline to receive standard therapy that has been shown to prolong overall survival, or if such therapy is not deemed in the participant s best interest, will be eligible, if other eligibility criteria are met. If appropriate, participants may remain on treatment during biopsy, screening and initial tissue review\u002Ftesting for this study.\n4. Participants must have measurable disease per RECIST v1.1. Note: Palliative radiotherapy to site(s) of disease may be completed during screening as long as disease outside of the planned sites of radiation is available for response assessment.\n5. Archival tumor (preserved via FFPE) must be available from a biopsy performed within the past 6 months. The timeframe of 6 months is required to optimize reliability of ENLIGHT results. It is assumed that a participant has had no more than one (1) line of systemic treatment since the last biopsy. Participants who have had multiple intervening lines of therapy since biopsy was obtained will be reviewed by the study team to determine if another biopsy may be needed. Note: If archival tissue is not available within that timeframe, tissue from the next scheduled biopsy can be sent to NIH for testing. If it is not possible for a biopsy to be scheduled, the study team will evaluate the possibility of a biopsy being performed at the NIH for enrollment purposes.\n6. Age \\>=18 years.\n7. ECOG performance status \\\u003C2 (Karnofsky \\>60%)\n8. Participants must have organ and marrow function as defined below:\n\n   * Hemoglobin \\>= 8g\u002FdL\n   * Absolute neutrophil count \\>= 1,200\u002FmcL\n   * Platelets \\>=75,000\u002FmcL\n   * Total bilirubin \\\u003C= 1.5 x institutional upper limit of normal (In the case of known Gilbert's Disease, total bili \\>1.5 may be considered.)\n\n   (For participants with known liver involvement, \\\u003C=3x institutional upper limit of normal)\n\n   -AST(SGOT)\u002FALT(SGPT) \\\u003C= 3x institutional upper limit of normal\n\n   (For participants with known liver involvement, \\\u003C=5x institutional upper limit of normal)\n\n   -Creatinine \\\u003C 1.5 x normal institutional limits OR Creatinine clearance \\>=30 mL\u002Fmin\u002F1.73 m2\n9. Ability to take oral medications.\n10. Participants with an existing diagnosis of diabetes or hypertension, must have disease well-controlled with at least annual physician follow-up.\n11. Women of child-bearing potential and men with a partner of child-bearing potential must be willing to use appropriate contraception in the event that they match to a therapy that requires such. The duration of contraception use will depend on the therapy assigned.\n12. Willingness to comply with required study procedures and visits for the duration of study.\n13. Participants with asymptomatic brain metastases may be included if metastases have been previously treated with local therapy including radiation at least 4 weeks prior to first dose of treatment and there is no indication for additional local therapy (including active progression).\n14. Participants with human immunodeficiency virus (HIV) must be on an effective anti-retroviral therapy with undetectable viral load for at least the last 6 months.\n15. Participants with evidence of chronic hepatitis B virus (HBV) infection, must have HBV viral load that is undetectable on suppressive therapy, if indicated.\n16. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection must be currently on treatment, with undetectable HCV viral load.\n17. Participants with a prior or concurrent malignancy are eligible if the natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the off-label therapies offered on this study in the opinion of the Principal Investigator (PI) and are otherwise eligible for this trial.\n18. Participants with 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. Note: To be eligible for this trial, participants should be class 2B or better.\n19. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1. Participants in active visceral crisis, symptomatic brain metastases requiring local therapy, or active leptomeningeal disease given the time required for testing and therapy selection.\n2. Participants with uncontrolled intercurrent illness evaluated by physical exam and chemistries or situations that would limit compliance with study requirements, interpretation of results or that could increase risk to the participant.\n3. Participants with the following active cardiac conditions: symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia (per medical record).\n4. Participants with lung disease requiring continuous oxygen supplementation.\n5. Participants with decompensated cirrhosis and\u002For end-stage kidney disease on dialysis.\n6. Participants with positive serum or urine beta-HCG pregnancy test performed at screening.\n7. Participants who are unable to provide tissue specimens of sufficient quality for use in this study. Quality of DNA and RNA is determined during screening. This may be due to issues with biopsy sample collection, inadequate RNA extraction, or quality control failure. Participants may be re-screened if initial specimens are not adequate, if they are amenable to re-biopsy, and additional site(s) of disease for adequate re-sampling are available.",{"count":56,"type":22},175,"INTERVENTIONAL",[59],"NA","Background:\n\nBreast cancer is the most common cancer in US women. There are different types of breast cancers; some are aggressive and difficult to treat. Researchers want to know if an algorithm (ENLIGHT) can help choose approved drugs that will treat these cancers more effectively.\n\nObjective:\n\nTo test whether ENLIGHT can find better treatments for aggressive breast cancers.\n\nEligibility:\n\nPeople aged 18 years and older with triple-negative or endocrine therapy resistant breast cancer; the cancer must have either failed to respond to treatment or come back after treatment.\n\nDesign:\n\nParticipants will be screened. A sample of tissue taken from the tumor will be tested using ENLIGHT as well as another method (TruSight Oncology 500).\n\nParticipants will be assigned to 1 of 3 groups based on the algorithm search results:\n\nGroup 1: No drug option was recommended. Participants will continue with their standard treatment with their local doctors.\n\nGroup 2: A drug already approved for the participant's disease was recommended, but the participant has not yet received it. These results will be sent to the participant's local doctors. Participants may return to the NIH if their disease gets worse after using the suggested drugs.\n\nGroup 3: A drug approved for other uses was recommended. Participants will be treated with the recommended drugs at the NIH; their care will be managed by an NIH doctor. They will continue to receive treatment as long as the drugs are helping them. They will have follow-up visits for 2 years after treatment ends.\n\nParticipants who are not treated at the NIH will be contacted for a check on their health every 3 months for 2 years.",[26,27,28,29],[63,31,64,65],"ENLIGHT","Her2","NSR device","RECRUITING",{"date":38,"type":39},{"date":69,"type":39},"2026-02-23",{"date":71,"type":22},"2029-08-04",{"name":45,"class":46},{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":57,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100482119","phase-2-low-dose-aspirin-for-the-prevention-of-postpartum-related-breast-cancer-100482119","NCT05557877","Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer","Targeted Prevention of Postpartum-Related Breast Cancer","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age \\>= 18 years and =\\\u003C 45 years of age\n* PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research at two timepoints.\n* PRE-REGISTRATION: Had a live birth =\\\u003C 10 years prior to pre-registration\n* PRE-REGISTRATION: Pre-menopausal according to patient report and\u002For clinical determination\n* PRE-REGISTRATION: Provide written informed consent\n* PRE-REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance\n* PRE-REGISTRATION: Willingness to provide mandatory blood and urine specimens for correlative research\n* REGISTRATION: Age \\>= 18 years and =\\\u003C 45 years of age\n* REGISTRATION: Registration for this study must be completed either =\\\u003C one (1) year after the qualifying pre-registration biopsy is performed for this study or =\\\u003C one (1) year after collection of the archived tissue (for those who did not have a pre-registration biopsy performed after pre-registration for this study)\n* REGISTRATION: Hemoglobin \\>= 9.0 g\u002FdL (obtained =\\\u003C 90 days prior to registration)\n* REGISTRATION: Platelet count \\>= 100,000\u002Fmm\\^3 (obtained =\\\u003C 90 days prior to registration\n* REGISTRATION: Serum creatinine =\\\u003C 2.0 mg\u002Fdl (obtained =\\\u003C 90 days prior to registration)\n* REGISTRATION: Negative pregnancy test done =\\\u003C 15 days prior to registration\n* REGISTRATION: Willing to use contraception while on treatment\n* REGISTRATION: Provide written informed consent\n* REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance\n* REGISTRATION: Willingness to provide mandatory blood and urine specimens for correlative research\n* REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research\n* REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: History of breast cancer including ductal breast carcinoma in situ (DCIS)\n* PRE-REGISTRATION: Received systemic treatment for any other cancer at any time\n* PRE-REGISTRATION: Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS) (no doses within =\\\u003C 5 days prior to pre-registration and no more than four doses within =\\\u003C 30 days prior to pre-registration)\n* PRE-REGISTRATION: Currently taking other agents for the prevention of breast cancer\n* PRE-REGISTRATION: Currently taking anticoagulants\n* PRE-REGISTRATION: Contraindication for aspirin use\n* PRE-REGISTRATION: Known or suspected active breast infection\n* REGISTRATION: Known DCIS or invasive cancer\n* REGISTRATION: No research tissue available from pre-registration biopsy or from archived tissue (collected =\\\u003C 12 months prior to pre-registration)\n* REGISTRATION: Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) (NOTE: no doses within =\\\u003C 5 days prior to registration and no more than four doses within =\\\u003C 30 days prior to registration)\n* REGISTRATION: Co-morbid illnesses\u002Fconditions 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 the prescribed regimens\n* REGISTRATION: Any contraindication to aspirin use including but not limited to:\n\n  * Bleeding disorders (e.g., hemophilia)\n  * Stomach or intestinal bleeding =\\\u003C 6 months prior to registration\n  * Known allergy to other non-steroidal anti-inflammatory drugs (NSAIDs)\n* REGISTRATION: Currently taking anticoagulants\n* REGISTRATION: Any prior or current malignancy requiring prior or current systemic therapy\n* REGISTRATION: Currently pregnant or planning to become pregnant in the next 90 days\n* REGISTRATION: Post-menopausal:\n\n  * Prior bilateral surgical oophorectomy or\n  * No menses for \\> 1 year with estradiol levels within postmenopausal range, according to institutional standard\n* REGISTRATION: Known or suspected active breast infection",true,"FEMALE","45 Years",{"count":84,"type":22},60,[86],"PHASE2","This phase II trial tests whether low-dose aspirin can affect markers of inflammation in postpartum (after childbirth) women planning to have a breast biopsy. Chronic inflammation may increase the risk of postpartum related breast cancer. Low-dose aspirin is a non-steroidal anti-inflammatory drug. Giving low-dose aspirin may affect markers of inflammation in blood and tissue and may prevent postpartum related breast cancer.",[27],"2026-08-18",{"date":36,"type":39},{"date":92,"type":39},"2023-03-09",{"date":94,"type":22},"2027-01-30",{"name":96,"class":97},"Mayo Clinic","OTHER",5,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":106,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":57,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":47},"100499790","home-based-respiratory-muscle-training-for-minimizing-side-effects-in-patients-undergoing-treatment-for-cancer-100499790","NCT05787834","Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Cancer","Respiratory Muscle Training During Cancer Treatment: Effects on the Autonomic Nervous System and Cardiotoxicity","Inclusion Criteria:\n\n* Able and willing to provide written informed consent\n* Age \\>= 21 years old\n* Diagnosed with solid tumor (e.g., head and neck, thoracic, or breast cancer)\n* Scheduled to receive at least one dose of chemotherapy or immunotherapy or radiation\n* Treated at Roswell Park Comprehensive Cancer Center\n\nExclusion Criteria:\n\n* Presence of oral mucosal disease including oral mucositis, or oral candidiasis detected at baseline\n* Have uncontrolled intercurrent illness including, but not limited to, ongoing or active respiratory infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention","21 Years",{"count":108,"type":22},130,[59],"This clinical trial evaluates whether home-based respiratory muscle training is useful for minimizing side effects in patients undergoing treatment for cancer. Over-activation of the nervous system during breast cancer treatment can result in heart- and lung-related side effects which have the potential to reduce a patient's quality of life. Aerobic exercise can help prevent the development of these side effects. However, engaging in regular aerobic exercise may be difficult for breast cancer patients who are actively undergoing treatment. Respiratory muscle training (RMT) involves a series of breathing and other exercises that are performed to improve the function of the respiratory muscles through resistance and endurance training. Home-based RMT may represent a more feasible approach for reducing side effects in patients undergoing treatment for breast cancer.",[27,112,113],"Head and Neck Cancer","Lung Cancer","2026-08-17",{"date":116,"type":39},"2026-08-19",{"date":118,"type":39},"2023-10-16",{"date":120,"type":22},"2029-10-16",{"name":122,"class":97},"Roswell Park Cancer Institute",{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":81,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":57,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":47},"100332134","phase-1-serial-imaging-of-the-novel-radiotracer-18f-fluorthanatrace-18f-ftt-by-petctf-100332134","NCT03604315","Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET\u002FCTF","Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET\u002FCT","Inclusion Criteria:\n\n* History of known or suspected solid tumor.\n* At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. computed tomography \\[CT\\], magnetic resonance imaging \\[MRI\\], ultrasound, fludeoxyglucose \\[FDG\\] PET\u002FCT).\n\nExclusion Criteria:\n\n* Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential \\\u003C 2 weeks prior to screening as standard of care.\n* Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.\n* Any current medical condition, illness, or disorder as assessed by medical record review and\u002For self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.",{"count":131,"type":22},300,[133],"PHASE1","This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)\u002Fcomputed tomography (CT) works in patients with solid tumors. Fluorine F 18 fluorthanatrace is a radioactive tracer, a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET\u002FCT uses a scanner to make detailed, computerized pictures of areas inside the body. PET\u002FCT with Fluorine F 18 fluorthanatrace may allow more tumor cells to be found in patients with ovarian, fallopian tube, or primary peritoneal cancer.",[27,136,137,138,139,140,141,142],"Fallopian Tube Carcinoma","Ovarian Carcinoma","Primary Peritoneal Carcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Solid Neoplasm",{"date":116,"type":39},{"date":145,"type":39},"2018-12-18",{"date":147,"type":22},"2027-06-30",{"name":149,"class":97},"M.D. Anderson Cancer Center",{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":57,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":47},"100596623","a-3d-printed-external-breast-prosthesis-for-the-improvement-of-patient-reported-outcomes-among-breast-cancer-patients-that-underwent-a-mastectomy-without-reconstruction-100596623","NCT07047872","A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction","Patient Reported Outcomes Post-Mastectomy and In-house 3D-printed Individualized External Breast Prostheses","Inclusion Criteria:\n\n* Adult individuals aged 18 years or older\n* History of unilateral or bilateral mastectomy for any indication\n* No implant or autologous reconstruction\n\n  * Allowed: Goldilocks closure, flat closure, simple skin closure\n* Willingness to participate in the study by completing PRO assessments or receiving personalized 3D-printed breast prostheses\n* Ability to provide informed consent\n* Ability to complete study procedures, including surface scanning (with temporary fiducial skin markers), standardized photography, and surveys at 1, 3, 6, and 12 months\n\nExclusion Criteria:\n\n* Individuals with contraindications for participation, such as severe medical conditions that may interfere with study procedures\n* Lack of willingness or capacity to provide informed consent for study participation\n* Inability to communicate effectively in the study language (e.g., English)\n* Patients with open wounds, active infection, or dermatologic conditions at the chest\u002Fbreast site that would interfere with scanning, fiducial marker placement, or prosthesis use\n* Patients unwilling or unable to undergo surface scanning, standardized photography, or complete survey follow-up",{"count":158,"type":22},50,[59],"This clinical trial evaluates whether a three-dimensional (3D)-printed external breast prosthesis improves patient-reported outcomes (PRO) among breast cancer patients that underwent surgical removal of the breast (mastectomy) without surgical reconstruction. Breast cancer remains a significant health concern and often requires a mastectomy. While breast reconstruction is a common option following a mastectomy, some patients decide not to undergo it or are not candidates. An external breast prosthesis is worn on the outside of the body to replace the breast that was removed during the mastectomy. Traditional external breast prostheses may lack comfort and fit. A 3D-printed external breast prosthesis is customized to the patient using 3D imaging along with computer-aided design (CAD) to interpret the 3D imaging to develop and print a patient-specific external breast prosthesis. This may create a better fitting prosthesis which may improve PRO.",[27],"2026-08-13",{"date":114,"type":39},{"date":165,"type":39},"2024-11-05",{"date":167,"type":22},"2027-11-05",{"name":96,"class":97},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":80,"sex":17,"minAge":82,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":57,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},"100592628","the-vanguard-study-testing-a-new-way-to-screen-for-cancer-100592628","NCT06995898","The Vanguard Study: Testing a New Way to Screen for Cancer","Inclusion Criteria:\n\n* Ages 45-75 years old\n* Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment\n* Agree to allow collection of information from their medical records for study-related purposes\n* Understand and be able to complete informed consent and participant questionnaires in English, Spanish, or Arabic\n\n  * Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion\n\nExclusion Criteria:\n\n* Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years\n\n  * Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ) or nonmelanoma skin cancer are eligible. Persons with a history of prostate cancer that has not been treated are not eligible, regardless of when the diagnosis occurred\n* Ongoing cancer diagnostic work-up\n* Ongoing participation in another study of an investigational cancer screening test or technology not currently utilized in routine clinical practice\n* Currently breastfeeding or pregnant, or planning to become pregnant in the next year\n* History of solid organ or hematopoietic transplantation at any time, or blood transfusion within the last 30 days","75 Years",{"count":177,"type":22},24000,[59],"The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).",[181,27,182,183,184,185,186,187,137,188,189],"Bladder Carcinoma","Colorectal Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Liver Carcinoma","Lung Carcinoma","Malignant Solid Neoplasm","Pancreatic Carcinoma","Prostate Carcinoma",{"date":191,"type":39},"2026-08-14",{"date":193,"type":39},"2025-06-18",{"date":195,"type":22},"2029-06-30",{"name":45,"class":46},40,{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":57,"phases":208,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100582923","omission-of-axillary-lymph-node-dissection-in-case-of-tumor-spread-to-lymph-nodes-in-the-armpit-in-breast-cancer-100582923","NCT06869629","Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer","SENOMAC-ULTRA: A Prospective Randomised Trial on the Omission of Axillary Lymph Node Dissection in Ultrasound-detectable Axillary Metastases in Primary Breast Cancer Treated by Upfront Surgery","SENOMAC-ULTRA","Inclusion Criteria:\n\n* Patients with primary invasive breast cancer clinical stage II-III\n* Palpable or non-palpable axillary metastases visible by ultrasound (other imaging accepted if confirmatory ultrasound is performed) and confirmed by fine needle aspiration or core biopsy\n* Written informed consent\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Distant metastases\n* Ipsilateral metastases in internal mammary, infra- or supraclavicular lymph nodes without confirmed axillary nodal involvement\n* Preoperative suspicion of extensive nodal involvement, i.e. locally advanced disease\n* Nodes fixed to each other or to neighbouring structures on palpation or imaging\n* History of contralateral invasive breast cancer within 5 years\n* Bilateral invasive breast cancer if (i) one side meets any exclusion criteria or (ii) both sides meet all inclusion criteria\n* Pregnancy\n* Neoadjuvant systemic treatment (short course of neoadjuvant endocrine therapy \\\u003Cthree months is allowed)\n* Medical contraindications for or expressed preoperative wish to abstain from radiotherapy or the recommended adjuvant systemic treatment which complies with standard of care, taking age and comorbidity into consideration\n* Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia",{"count":207,"type":22},1380,[59],"SENOMAC-ULTRA enrols patients who are planned for upfront surgery for a breast cancer that has spread to lymph nodes in the armpit, and that have been detected already prior to surgery by imaging, e.g. ultrasonography. In this situation, a full axillary lymph node dissection, removing more than 10 lymph nodes from the arm pit, is unnecessarily extensive in about half of the patients. More extensive surgery leads to a risk for arm lymphedema and functional problems with the arm and shoulder region, which should be avoided if not beneficial for diagnosis or prognosis. This trial seeks to ascertain that less extensive surgery, performed by only removing the first lymph node\u002Fs in the armpit (the sentinel lymph node\u002Fs) and the known metastatic lymph nodes (targeted axillary dissection, TAD), offers non-inferior survival outcomes to a full axillary lymph node dissection.",[27,26,211],"Breast Surgery",[213,214,215,216,217],"axillary metastases","axillary lymph node dissection","targeted axillary dissection","sentinel lymph node biopsy","axillary ultrasonography",{"date":114,"type":39},{"date":220,"type":39},"2026-05-13",{"date":222,"type":22},"2041-12-31",{"name":224,"class":97},"Karolinska Institutet",4,{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":80,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":57,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":243,"locationsCount":47},"100651862","mobile-health-patient-navigation-for-the-improvement-of-screening-and-the-early-detection-of-breast-cancer-in-women-accessing-primary-care-clinics-in-kenya-100651862","NCT07764796","Mobile Health Patient Navigation for the Improvement of Screening and the Early Detection of Breast Cancer in Women Accessing Primary Care Clinics in Kenya","A Multi-Level Strategy for Integrating Information Technology and Mobile Health to Strengthen Linkages to Breast Cancer Screening and Early Detection Among Women Utilizing Primary Care in Kenya (MATITI YANGU)","Inclusion Criteria:\n\n* AIM 1: All members of BREAKTHROUGH's Stakeholder Advisory Board (SAB) breast cancer working group\n* AIM 1: Participants (patients and health providers) from primary health care clinics in Nairobi County\n* AIM 1: Will include women (patients) aged over 35 years and speak either Kiswahili or English\n* AIM 1: Include women who:\n\n  * Have never undergone MMG screening\n  * Previously undergone MMG screening\n  * Experienced breast abnormalities and have been referred for or undergone diagnostic investigations\n  * Are currently undergoing or have received breast cancer treatment\n* AIM 1: Health care providers and breast screening facility staff (i.e. primary care clinic nurses, MMG clinic staff and technicians) will also be recruited\n* AIM 2: Will engage with a diverse group of local and national interagency stakeholders, Nairobi County health leadership, and health providers across different levels of the health system\n* AIM 3: Women aged 35 years and older who are able to provide informed consent who are attending the outpatient clinics for primary health care\n* AIM 4: Members of SAB breast cancer group, health facilities leadership (all health facility levels)\n\nExclusion Criteria:\n\n* AIM 1: Those who will be unwilling to consent and those who are unable to consent will be excluded from the study\n* AIM 2: Those who will be unwilling to consent and those who are unable to consent will be excluded from the study\n* AIM 3: Women undergoing breast cancer treatment and women aged 70 years and above will be excluded\n* AIM 4: Members of SAB breast cancer group, and health facilities leadership who will be unwilling and unable to consent will be excluded",{"count":234,"type":22},800,[59],"This clinical trial develops and studies how well mobile health (m-Health) patient navigation (PN) strategies work to improve screening and the early detection of breast cancer in women accessing primary care clinics in Kenya. Although highly curable, breast cancer kills thousands of women in developing countries yearly. Mammography (MMG) is used for the early detection of breast cancer by creating a picture of the breast using film or a computer. Despite the availability of MMG in all 47 counties in Kenya, screening remains low in eligible women. Early detection of breast cancer may also be improved through access to high quality clinical breast exams (CBE). However, primary care providers in Kenya face barriers to incorporating CBE into practice, including limited patient awareness of breast cancer screening. m-Health uses applications on mobile phones to deliver PN directly to the patients. The PN strategies in this study include digital platforms and tools to help with education, reminders, navigation, and motivation around breast cancer screening. This may improve screening and the early detection of breast cancer in women accessing primary care clinics in Kenya.",[27],"2026-08-10",{"date":191,"type":39},{"date":241,"type":39},"2025-07-22",{"date":195,"type":22},{"name":244,"class":97},"Emory University",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":80,"sex":81,"minAge":252,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":47},"100317109","mammography-early-detection-biomarkers-risk-assessment-and-imaging-technologies-merit-study-100317109","NCT03408353","Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study","MERIT (Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies) Cohort","Inclusion Criteria:\n\n* Willingness to participate in the study and ability to provide informed consent\n* Willingness to complete a questionnaire and to provide a blood sample at the initial visit and at follow up annual visits\n* Undergoing a screening mammogram at participating sites. Subjects undergoing routine annual diagnostic mammograms or CEM as part of a screening study are also eligible.\n\nExclusion Criteria:\n\n* Current or recent (within the prior 6 months) history of breast feeding\n* Personal history of breast cancer (ductal breast carcinoma in situ \\[DCIS\\] or invasive breast cancer)\n* Personal history of any other cancer (excluding in-situ, stage 0, and non-melanoma skin cancers and other pre-cancerous conditions) treated within the last 5 years.","25 Years","80 Years",{"count":255,"type":22},10000,"This study collects mammogram images, blood samples, and clinical information from women undergoing routine screening mammograms. Creating a bank of blood samples and a database of clinical and risk information may be used in future research related to breast cancer, other cancers, and women's health.",[27],"2026-08-07",{"date":260,"type":39},"2026-08-11",{"date":262,"type":39},"2017-09-15",{"date":264,"type":22},"2027-04-30",{"name":149,"class":97},{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":81,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":57,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"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":274,"type":22},126,[59],"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.",[278,279,280,281,27,282,283,284,137,285,286,287,288,289,290,291,292,293],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Breast Mixed Epithelial\u002FMesenchymal Metaplastic Carcinoma","Endometrial Carcinoma","Malignant Female Reproductive System Neoplasm","Ovarian Carcinosarcoma","Stage III Cervical Cancer AJCC v8","Stage III Vaginal Cancer AJCC v8","Stage III Vulvar Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Vaginal Cancer AJCC v8","Stage IV Vulvar Cancer AJCC v8","Triple-Negative Breast Carcinoma","Uterine Corpus Carcinosarcoma","2026-08-06",{"date":238,"type":39},{"date":297,"type":22},"2027-02-22",{"date":299,"type":22},"2028-01-16",{"name":301,"class":97},"City of Hope Medical Center",11,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":81,"minAge":18,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":57,"phases":314,"briefSummary":315,"conditions":316,"keywords":320,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":47},"100630031","supporting-health-including-endocrine-treatment-for-long-duration-100630031","NCT07482384","Supporting Health Including Endocrine Treatment for Long Duration","Supporting Health Including Endocrine Treatment for Long Duration: A Pilot Intervention","SHIELD","Inclusion criteria\n\nParticipants will be eligible if they meet the following eligibility criteria:\n\n* Female\n* Age 18-49 years at diagnosis of a stage 0-IIIa, HR+ breast cancer\n* Premenopausal\n* In active treatment (including long-term endocrine therapy) at the time of enrollment\n* Able to speak, understand and read English\n* Access to a US-based mobile phone number\n* Cognitively able to complete study requirements\n* Ability to access medical records from treating hospital (DFCI)\n* Willing to provide cell phone number and\u002For email address and willing to receive email, mobile push notifications, and\u002For text messages from the study team\n\nExclusion criteria\n\nParticipants will be ineligible if they meet any of the following criteria:\n\n* Individuals under age 18 or over age 50 at initial breast cancer diagnosis\n* Stage IV or metastatic breast cancer\n* Pregnant patients\n* Individuals who do not have a US mobile phone number\n* Males with breast cancer are not being recruited to this protocol. In the adolescent and young adult (AYA) age group, only a miniscule proportion of breast cancers occur in males. Additionally, this pilot focuses on breast cancer treatment utilizing OFS and ET, both of which do not apply to males. For this reason, the SHIELD portal intervention materials have been targeted for young women.","49 Years",{"count":313,"type":22},30,[59],"This research is being done to pilot an intervention which aims to test a new web- and mobile application (\"app\")-based supportive care tool (SHIELD portal) and to assess the feasibility of enrolling female breast cancer patients with hormone receptor-positive disease long-term endocrine treatment.",[26,317,27,318,319],"Breast Cancer - Female","ER Positive Breast Cancer","PR-Positive Breast Cancer",[321,322,323,324,309],"Breast cancer","Breast cancer female","Breast carcinoma","ER+",{"date":238,"type":39},{"date":327,"type":39},"2026-08-04",{"date":329,"type":22},"2027-05",{"name":331,"class":97},"Dana-Farber Cancer Institute",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":352},"100478277","trpc6-characterization-to-predict-and-prevent-chemotherapy-related-cardiomyopathy-and-heart-failure-with-breast-cancer-100478277","NCT05507879","TRPC6 Characterization to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure With Breast Cancer","Characterization of TRPC6 to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure (Prospective Study)","Inclusion Criteria:\n\n* 18 years of age or older\n* Any breast cancer patient initiating doxorubicin\u002Fother anthracycline and patients receiving trastuzumab without doxorubicin\u002Fanthracycline in the neoadjuvant\u002Fadjuvant setting\n* An understanding of the protocol and its requirements, risks, and discomforts\n* The ability and willingness to sign an informed consent\n* Diagnosed with therapy related cardiotoxicity defined as; cardiomyopathy, symptomatic heart failure, asymptomatic reduced systolic function, acute coronary syndrome, myocardial infarction, critical limb ischemia, cardiac arrhythmias or myocarditis possibly related to prior cancer treatment OR completed chemotherapy with no cardiotoxicity at least two years post treatment OR patients with cancer who will be initiating systemic therapy with potentially cardiotoxic medications. This will include doxorubicin chemotherapy, or trastuzumab.\n* Healthy, non-pregnant, adult subjects who weigh at least 110 pounds\n\nExclusion Criteria:\n\n* Inability on the part of the patient to understand the informed consent or be compliant with the protocol\n* Anemia with hemoglobin less than 8\n* Patients not willing to undergo a blood draw\n* Patients with stage IV or distant metastatic breast cancer",{"count":340,"type":22},200,"This study examines TRPC6 in predicting and preventing chemotherapy related cardiac toxicity and heart failure in patients with breast cancer. Cardiac toxicity, changes in heart function is a well-recognized complication of certain cancer related therapies. Understanding these changes may allow early intervention against therapy-related cardiac toxicity and also identify novel therapeutic targets to protect patient long-term cardiac health. Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA), identify biomarkers related to cardiac toxicity, and prevent the development of therapy-induced cardiac toxicity in patients receiving chemotherapy.",[27,343,344],"Cardiomyopathy","Congestive Heart Failure",{"date":346,"type":39},"2026-08-05",{"date":348,"type":39},"2022-09-26",{"date":350,"type":22},"2030-07-01",{"name":96,"class":97},2,{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":57,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":376},"100531093","phase-2-low-dose-tamoxifen-with-or-without-omega-3-fatty-acids-for-breast-cancer-risk-reduction-100531093","NCT06195306","Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction","Phase 2 Study of Low Dose Tamoxifen +\u002F- High Dose Omega-3 Fatty Acids in Overweight Postmenopausal Women at Increased Risk for Breast Cancer","Inclusion Criteria:\n\n* Age 45 - 74\n* Postmenopausal female\n\n  * Postmenopausal is defined as either\n\n    * Prior removal of the ovaries, or if ovaries intact amenorrhea for \\>= 12 months and not on any form of contraception, or\n    * Amenorrhea for greater than 2 months with serum follicle-stimulating hormone (FSH) in postmenopausal range (\\>= 25 IU\u002FL). Women with ovaries and a prior hysterectomy or endometrial ablation \\\u003C age 55 must have a FSH \\>= 25 IU\u002FL. Women may be on vaginal low dose estrogen preparations for vaginal dryness. Women over age 50 with a levonorgestrel intrauterine device in place for 2 or more years and not planning removal in the next 6 month are also eligible if FSH \\>= 25 IU\u002FL\n\n      * Note: FSH will be done at time of screening\n* Women with intact ovaries and uterus \\\u003C age 55 must have a negative pregnancy test prior to randomization\n* Overweight or obese (body mass index \\[BMI\\] \\>= 25 kg\u002Fm\\^2)\n\n  * Note: BMI must be calculated within 28 days of randomization\n* Willing to undergo a fasting blood draw and non-fasting RPFNA with fixed and frozen aliquots sent to University of Kansas Medical Center (KUMC)\n* At increased risk of breast cancer per at least one of the following:\n\n  * Personal medical history\n\n    * History of atypical hyperplasia or lobular carcinoma in situ (LCIS) found on breast biopsy\n    * History of unilateral ductal carcinoma in situ treated with unilateral mastectomy, lumpectomy, or local excision with or without radiation and this treatment was completed at least 3 months prior to the screening RPFNA\n    * High mammographic density determined by one of the following:\n\n      * Visual estimate of area of density (VAS) \\> 50%,\n      * Volpara (trademark) \\>= 15% dense volume (Volpara d)\n      * Breast Imaging Reporting and Data System (BIRADS) assessment = extremely dense (BIRADs D)\n  * Genetic test result\n\n    * Germline gene mutation in ATM, BARD1, BRCA2, CDH1, CHEK2, NF1, PALB2, PTEN, RAD51C, RAD51D, or STK11\n    * Polygenic lifetime risk score \\>= 2x average or 25%\n  * Calculated risk based on standard models\n\n    * Five-year Breast Cancer Risk Assessment Tool (BCRAT) (version 2.0) \\>= 1.66%\n    * Ten-year International Breast Cancer Intervention Study risk evaluation tool (IBIS) (version 8) \\>= 3%\n    * Ten-year relative risk IBIS (version 8) \\>= 2X that for age group\n    * Ten- year Breast Cancer Surveillance Consortium (version 2) \\>= 3%\n  * Family History\n\n    * Breast cancer in a first or second degree relative (female or male) with onset under age 50. (First degree relative = parent, sibling, or child. Second degree relative = grandparent, uncle, aunt, nephew, niece, half-sibling, grandchild or first cousin)\n    * Breast cancer in two or more first or second-degree relatives from either the maternal or paternal linage without regard to age\n    * Bilateral breast cancer or breast and ovarian cancer in the same first or second degree relative without regard to age\n  * Primary source documentation of risk is required and must be submitted to the lead academic organization (LAO) for review along with the eligibility checklist\n\n    * Risk factor: Atypical hyperplasia or LCIS; Primary source document: Copy of pathology report or clinical note confirming the diagnosis\n    * Risk factor: Ductal carcinoma in situ (DCIS) and treatment history; Primary source document: Copies of pathology report or clinic notes confirming the diagnosis, treatment plan and treatment end date(s)\n    * Risk factor: Mammographic density; Primary source document: Copy of clinic note or mammogram report\n    * Risk factor: Genetic; Primary source document: Copy of genetic test report\n    * Risk factor: Calculated based on standard models; Primary source document: Copy of the calculation result\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n\n  * Note: Higher total bilirubin levels (=\\\u003C 3 mg\u002FdL) can be allowed if due to known benign liver condition, i.e., Gilbert's syndrome\n  * Results from prior laboratory testing within 180 days of randomization may be used\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 3.0 x institutional upper limit of normal\n\n  * Results from prior laboratory testing within 180 days of randomization may be used\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3.0 x institutional upper limit of normal\n\n  * Results from prior laboratory testing within 180 days of randomization may be used\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 on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Women must have at least 1 unaffected untreated breast for fine needle aspiration. Women may have had prior unilateral breast radiation or mastectomy for DCIS\n* Ability to understand and the willingness to sign a written informed consent document\n* Most recent screening mammogram must be performed ≤ 12 months prior to RPFNA and must be reported as BIRAD 1 or 2. If BIRAD 0 then follow-up diagnostic imaging must be BIRAD 1 or 2 or cleared clinically with radiology recommendation of return to annual screening\n* Confirmation that baseline research blood was drawn fasting (\\>= 10 hours), has been received in good condition at KUMC, and is archived for assessment of primary endpoint\n\nExclusion Criteria:\n\n* Exclusions based on current or past conditions:\n\n  * Bilateral breast implants (danger of implant puncture with RPFNA)\n  * Prior invasive breast cancer\n  * Prior invasive uterine cancer\n  * Other prior invasive cancer and haven't completed cancer related therapy or with evidence of disease (other than non-melanoma skin cancer) within the past 2 years\n  * Currently breastfeeding (concern that tamoxifen may be in breast milk) or nursing within past 12 months (concern about milk fistula with RPFNA)\n  * Type I or type II diabetes mellitus requiring current pharmacologic treatment (including metformin, glucagon-like peptide 1 agonists, insulin, sulfonylurea)\n  * Prior deep vein thrombosis, pulmonary embolus, or stroke\n  * Prior gastric bypass surgery\n  * History of chronic liver disease including NASH (nonalcoholic steatohepatitis) or cirrhosis\n  * Pathogenic or likely pathogenic germline mutation in BRCA1 or TP53\n* Exclusions based on medications:\n\n  * Current use of prescription anticoagulants such as Coumadin (warfarin), direct-acting oral anticoagulants such as Xarelto (rivaroxaban) or Eliquis (apixaban) or heparin\n  * Women who would not be able to or do not wish to discontinue daily use of aspirin (81mg or higher) and aspirin containing products (81 mg or higher) at least 3 weeks prior to each RPFNA\n\n    * Note: Women may resume daily use of aspirin and aspirin containing products 3 days after each RPFNA procedure\n  * Current use of a levonorgestrel intrauterine device if in place less than 2 years or if there is planned removal within the next 6 months\n  * Current use of hormone therapy (oral, transdermal, or injectable)\n\n    * Note: Vaginal estrogen is allowed\n  * Prior treatment with tamoxifen, aromatase inhibitor or selective estrogen receptor degrader for more than 2 months\n\n    * Note: Women with \\\u003C 2 months of these drugs must be off for at least 6 months before they may begin biomarker screening tests\n  * Greater than 1 gram daily of omega-3 fatty acid supplement within the last 6 months\n  * Current use of prescription immunosuppressive drugs\n  * Current use of CYP3A4 strong inducers rifampin or aminoglutethimide\n  * Current use of or plans to initiate a glucagon-like peptide 1 agonist within the next 6 months\n  * Current use of metformin for any indication\n* Participants may not be receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to tamoxifen or omega-3 fatty acid or generic Lovaza or compounds of similar chemical composition\n* Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements","74 Years",{"count":362,"type":22},66,[86],"This phase II trial evaluates tamoxifen, with or without omega-3 fatty acids, for reducing risk of breast cancer among postmenopausal and overweight or obese women who are at increased risk of developing breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen is approved by the Food and Drug Administration for prevention of breast cancer in women at increased risk. Omega-3 fatty acids have been shown to decrease the amount of fats made in the liver. Omega-3 fatty acids may work to prevent cancer in overweight or obese individuals. Tamoxifen with or without omega-3 fatty acids may be effective at reducing risk of breast cancer among women who are postmenopausal, overweight or obese, and at increased risk.",[366,27,367,368],"Breast Atypical Hyperplasia","Breast Ductal Carcinoma In Situ","Breast Lobular Carcinoma In Situ","2026-08-01",{"date":327,"type":39},{"date":372,"type":39},"2025-07-28",{"date":374,"type":22},"2028-01-01",{"name":45,"class":46},3,{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":57,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":47},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease 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 the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":385,"type":22},27,[86],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[389,390,391,181,27,392,182,283,136,393,394,395,396,397,398,186,187,399,400,401,402,403,137,188,138,189,404,405,406],"Amyloidosis","Basal Cell Carcinoma","Biliary Tract Carcinoma","Cervical Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hepatocellular Carcinoma","Hodgkin Lymphoma","Mantle Cell Lymphoma","Melanoma","Merkel Cell Carcinoma","Multiple Myeloma","Myelodysplastic Syndrome","Renal Cell Carcinoma","Squamous Cell Carcinoma","Urothelial Carcinoma","2026-07-28",{"date":409,"type":39},"2026-07-30",{"date":411,"type":39},"2025-12-18",{"date":413,"type":22},"2026-12-18",{"name":96,"class":97},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":81,"minAge":18,"maxAge":422,"enrollmentInfo":423,"targetDuration":4,"studyType":57,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":302},"100530282","phase-2-finding-the-best-tamoxifen-dose-for-breast-cancer-risk-reduction-in-premenopausal-women-renaissance-trial-100530282","NCT06184750","Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial","Refining Tamoxifen Dose for Premenopausal Breast Cancer Risk Reduction (RENAISSANCE): A Phase II Single Arm Trial","Inclusion Criteria:\n\n* Premenopausal women at the time of enrollment defined by any of the following:\n\n  * Age under 50 years and regular menstruation (most recent period within the past 3 months)\n  * Age under 50 years and continuous hormonal contraception use and at least one intact ovary\n  * Women who are not postmenopausal based on serum hormone levels. Women with estradiol \\> 30 pg\u002FmL and follicle-stimulating hormone (FSH) \\\u003C 30 IU\u002FmL are eligible\n* Women with any of the following:\n\n  * A history of unilateral estrogen receptor (ER) positive ductal carcinoma in situ (DCIS) with local therapy completed (as determined by treating physician recommendation and patient acceptance) at least 1 month prior to study entry. (The untreated breast will be the study breast, for both imaging and optional biopsy)\n  * Recent or prior lobular carcinoma in situ (LCIS), or any form of epithelial atypia, flat epithelial (FEA), atypical ductal hyperplasia (ADH), or atypical lobular hyperplasia (ALH)\n  * Are risk eligible for preventive medication based on a five-year risk of 1.7% or greater, estimated with a validated model: the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool, Tyrer-Cusick, Breast Cancer Surveillance Consortium. If the Tyrer-Cuzick model is used a ten-year risk of 3.4% or greater is acceptable\n  * Are tamoxifen-eligible by American Society of Clinical Oncology (ASCO) guidelines (\\>= 2-fold increased risk compared to peer if age \\>= 45 years, and \\>= 4-fold increased risk if age \\\u003C 45 years)\n  * A history of mantle radiotherapy\n  * A moderate penetrance germline pathogenic variant\n* Participants ≥ 18 and ≤ 55 years old will be enrolled. Our trial objectives are not relevant to females under 18 years of age since breast cancer is extraordinarily rare in this age group, and there are no guidelines regarding use of tamoxifen in children, even if know to be at very high risk for breast cancer when older. Because no dosing or adverse event (AE) data are currently available on the use of tamoxifen in participants \\\u003C 18 years of age\n* Human immunodeficiency virus (HIV)-infected patients are eligible to participate if they are on effective anti-retroviral therapy with undetectable viral load within the prior 6 months\n* Women with evidence of chronic hepatitis B virus (HBV) infection, are also eligible if the HBV viral load is undetectable; they may be on suppressive therapy, if indicated\n* Women with a history of hepatitis C virus (HCV) infection are eligible if treated and cured. For those who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Women with herpes simplex virus (HSV) infection are eligible if on chronic or as needed (due to a flare) suppressive antiviral therapy\n* Hormonal contraceptive users are eligible and should maintain the same hormonal contraceptive preparation throughout the duration of the trial. Changing hormonal contraception after enrollment for medical reasons is allowed\n* The effects of tamoxifen on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because tamoxifen is known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence; partner vasectomy) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\n* Ability to understand and the willingness to sign a written informed consent document\n* Breast Imaging Reporting and Data System (BIRADS) 1 or 2. Women with BIRADS 3 findings that have been biopsied and shown to be benign or are stable at 6-months follow-up are allowed\n* Women who are factor V leiden carriers and have not had a blood clot are eligible, if approved by their treating physician\n\nExclusion Criteria:\n\n* BIRADS breast density category A\n* History of selective estrogen receptor modulator (SERM) use within the past 5 years unless:\n\n  * Use was less than 6 months duration in the past 5 years and not used in the 1 year prior to enrollment OR\n  * Use was no greater than 2 months duration in the past 1 year and not used in the 6 months prior to enrollment\n* History of invasive breast cancer\n* Prior bilateral mastectomy or breast augmentation surgery including breast implants. Prior bilateral excisional surgical biopsy, mastopexy (breast lift) or mammoplasty (breast reduction) is allowed, as long as \\> 1 year has passed since the procedure\n* Women with \"mosaic mammographic screening views\", i.e., whose larger breast size precludes being imaged within a single mammographic screening view\n* Current use of a strong CYP3A4 inducer or a strong CYP2D6 inhibitor unless willing and able to discontinue use at least 30 days prior to screening and switch to an alternative medication for the duration of participation, under the advice of their physician. If the physician believes the current medication cannot be replaced, the participant will not be eligible\n* Current use of Warfarin\n* Planning to become pregnant within the next two years. Potential study participants will be questioned about this and excluded if they are planning pregnancy over the next 20 months\n* History of thromboembolism, pulmonary embolism, thrombotic stroke, arterial thrombosis of the extremity or deep vein thrombosis. A history of superficial thrombophlebitis is allowed\n* History of uterine cancer or atypical uterine hyperplasia with uterus intact\n* Participants may not be receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to tamoxifen\n* Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because tamoxifen a category D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with tamoxifen. Breastfeeding should be discontinued if the mother is treated with tamoxifen\n* Women with known gene mutations associated with an increased risk for breast cancer such as BRCA1\u002F2, CDH1, PALB2, PTEN, STK11, or P53\n* Current use of sex hormones (estrogen, progesterone, or androgens), unless part of hormonal contraception pills\n* Prior invasive cancer ≥ T1 (other than non-melanoma skin cancer), unless curatively treated, and all treatment was completed \\> 5 years prior to enrollment","55 Years",{"count":340,"type":22},[86],"This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at reduced dosages, and is approved for the prevention of breast cancer.",[427,428,27,367,368,429],"Breast Atypical Ductal Hyperplasia","Breast Atypical Lobular Hyperplasia","Estrogen Receptor-Positive Breast Carcinoma","2026-07-24",{"date":432,"type":39},"2026-07-27",{"date":434,"type":39},"2024-09-27",{"date":436,"type":22},"2028-09-30",{"name":45,"class":46},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":80,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":57,"phases":447,"briefSummary":448,"conditions":449,"keywords":459,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":47},"100640818","studying-the-workflow-of-the-american-college-of-surgeons-geriatric-surgery-program-to-improve-clinical-outcomes-in-older-adults-undergoing-surgery-at-the-james-cancer-hospital-100640818","NCT07606287","Studying the Workflow of the American College of Surgeons Geriatric Surgery Program to Improve Clinical Outcomes in Older Adults Undergoing Surgery at the James Cancer Hospital","Implementation of the American College of Surgeons Geriatric Surgery Verification Program at the James Cancer Hospital","Inclusion Criteria:\n\n1. Patient records for adults aged 65 years or older\n2. Patient records with a surgical encounter or preoperative evaluation within participating James Cancer Hospital surgical oncology services during the rollout period\n3. Patient records with data available in institutional electronic health record or institutional data systems\n4. Clinical staff age 18 years or older who are employed or credentialed at The Ohio State University Wexner Medical Center and work within clinical areas affected by ACS Geriatric Surgery Verification implementation\n\nExclusion Criteria:\n\n1. Patient records for encounters occurring only at outside institutions or non-James hospitals within the enterprise\n2. Patient records missing all primary outcome fields after data quality checks\n3. Clinical staff who are trainees, including medical students, physician assistant students, nursing students, resident physicians, or fellows\n4. Clinical staff whose employment, visa, or institutional status would make participation sensitive under institutional policy, if applicable",{"count":446,"type":22},4000,[59],"This study examines how the American College of Surgeons Geriatric Surgery Verification Program, also called the ACS GSV Program, is implemented at the James Cancer Hospital. The program is designed to improve surgical care for adults age 65 and older by helping care teams identify and address age-related needs before, during, and after surgery.\n\nOlder adults with cancer may have concerns related to physical function, memory or thinking, medications, social support, and goals of care. If these needs are not recognized, patients may be at higher risk for complications, longer hospital stays, readmission, or discharge to a facility instead of home.\n\nThe ACS GSV Program includes standards for geriatric surgery leadership, goals-of-care discussions, screening for age-related vulnerabilities, care plans for identified needs, age-friendly perioperative care, and regular review of surgical outcomes. This study will evaluate how well these standards are adopted across surgical oncology services and whether implementation is associated with better outcomes, such as shorter hospital stays, fewer complications, fewer readmissions, and improved discharge outcomes.\n\nThe results may help improve surgical care workflows for older adults undergoing cancer surgery.",[27,450,284,451,452,453,187,454,455,456,457,458],"Malignant Digestive System Neoplasm","Malignant Genitourinary System Neoplasm","Malignant Head and Neck Neoplasm","Malignant Nervous System Neoplasm","Malignant Thoracic Neoplasm","Skin Neoplasm","Soft Tissue Neoplasm","Central Nervous System Neoplasm","Endocrine Gland Neoplasms",[460,461],"geriatric surgery verification","oncogeriatrics","2026-07-22",{"date":464,"type":39},"2026-07-23",{"date":466,"type":22},"2026-11-15",{"date":468,"type":22},"2027-12-31",{"name":470,"class":97},"Ohio State University Comprehensive Cancer Center",{"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":57,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":47},"100526137","phase-1-immune-response-activation-for-the-treatment-of-unresectable-metastatic-colorectal-cancer-or-cea-positive-metastatic-breast-cancer-100526137","NCT06130826","Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer","A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Colorectal Cancer or CEA-Positive Metastatic Breast Cancer","Inclusion Criteria:\n\n* Patients should have a diagnosis of metastatic colon or rectal or breast cancer that is pathology proven\n* Patients should have a CEA producing colorectal cancer or breast cancer defined as a baseline CEA or prior documented CEA level exceeding 5 ng\u002Fml or evidence of CEA staining by Immunohistochemistry (IHC)\n* Patients should 18 years of age or older\n* Patients are willing and capable to consent to study and to adhere with all elements of the study\n* Patients who have failed to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist, is not tolerable or was refused\n* Patients should be at least 4 weeks from last receipt of a cytotoxic or biological agent prior to start of SBRT, with the exception of mitomycin C which requires a 6-week washout\n* Patients should have unresectable disease or not be a candidate for surgical resection\n* Patients must have a minimum of 1 and a maximum of 5 separate metastatic lesions planned for SBRT. (Patients may have \\> 5 metastatic lesions overall, however only up to 5 lesions will be treated with SBRT.) SBRT sites must be equal to or less than 5 cm in greatest dimension. SBRT treated sites must be measurable per RECIST 1.1 and can include metastatic sites in the lung, liver, or soft tissue. Sites that are intracranial or in the bone are excluded. Sites deemed not appropriate for SBRT by the treating radiation oncologist are also excluded\n* Patients should be at least 4 weeks from last radiation therapy prior to starting SBRT\n* Patients should be at least 4 weeks from any investigational therapy prior to starting SBRT, with the exception of prior immunotherapy which would require a 3 month washout\n* Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Patients should be considered clinically stable with an estimated overall survival of at least 3 months\n* Neutrophil count \\> 1500\u002Fmm\\^3\n* Lymphocyte count \\> 500\u002Fmm\\^3\n* Hemoglobin \\> 9 gm\u002Fdl\n* Platelets count \\> 100,000\u002Fmm\\^3\n* Aspartate transaminase (AST)\u002Falanine transaminase (ALT) \\\u003C 2.5 x upper limit of normal (ULN)\n* Bilirubin ≤ ULN\n* Patients should have adequate kidney function defined as a serum creatinine \\\u003C ULN or calculated creatinine clearance of \\> 60ml\u002Fmin (Cockroft-Gault formula)\n* Patients should have adequate cardiac function defined as:\n\n  * No history of acute coronary syndromes (including myocardial infarction, unstable angina, Coronary artery bypass grafting (CABG), coronary angioplasty, or stenting) \\\u003C 12 months prior to screening\n  * No impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:\n\n    * Symptomatic chronic heart failure;\n    * Evidence of clinically significant cardiac arrhythmias and\u002For conduction abnormalities\n  * No uncontrolled arterial hypertension despite appropriate medical therapy (defined as systolic blood pressure \\> 160 or diastolic blood pressure \\>100)\n  * Electrocardiogram (EKG) showing normal sinus rhythm and a corrected QT (QTc) ≤ 450 ms for male and ≤ 470 ms for female patients\n* Patients should have adequate pulmonary function defined as:\n\n  * Lack of uncontrolled pleural effusion requiring recurrent draining procedures (more than once per month)\n  * Lack of oxygen supplementation dependence\n* All subjects must have the ability to understand and the willingness to sign a written informed consent\n* Screening 2-dimensional (2-D) echocardiogram (echo) shows a left ventricular ejection fraction (LVEF) \\> 40%\n* Urinalysis shows lack of proteinuria or a maximum of 1+ proteinuria\n* Women of childbearing potential should use highly effective contraception while receiving the trial regimen and for at least 5 half-lives of M5A-IL2 from the last dose of M5A-IL2\n\nExclusion Criteria:\n\n* Patients on immunosuppressive treatments including supra-physiological doses of corticosteroids\n* Patients with history of auto-immune disease including history of inflammatory bowel disease\n* Patients with active brain metastases\n* Patients in the child-bearing ages who refuse to use adequate birth control measures (example: contraceptives, barrier method, or abstinence)\n* Lactating females who do not agree to stop breastfeeding\n* Known active hepatitis B or C\n* Major surgical procedure within 4 weeks prior to SBRT\n* Non-healed wound or surgical incisions\n* Radiographic evidence of bowel obstruction\n* Electrolyte disturbances (sodium, potassium, magnesium, calcium, and phosphorous) that are not correctable to at least CTCAE grade 1 with replacement therapy\n* Known hypersensitivity of any of the study drug agents or components\n* Patients should not have any uncontrolled illness including ongoing or active infection\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents\n* Pregnant women are excluded from this study because the investigational agents on this study are highly likely to exert teratogenic or abortifacient effects\n* Patients with other active malignancies are ineligible for this study\n* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study",{"count":479,"type":22},24,[133],"This phase I trial studies the side effects and best dose of M5A-IL2 immunocytokine (M5A-ICK) combined with stereotactic body radiation therapy (SBRT) and to see how well they work in treating patients with colorectal cancer or xarcinoembryonic antigen (CEA) positive breast cancer that cannot be removed by surgery (unresectable) or has spread from where it first started (primary site) to other places in the body (metastatic). Carcinoembryonic Antigen (CEA) is a protein that is present in most colorectal cancers and in many other cancers, such as breast cancer, as well. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Cytokines are signaling proteins that help control inflammation in the body. They allow the immune system to mount a defense if germs or cancer or other substances that can make people sick enter the body. Interleukin-2 (IL-2) is a powerful cytokine able to regulate the immune responses that are important for anticancer immunity. Immunocytokines (also called antibody-cytokine fusion proteins) are small proteins that regulate the activity of immune cells. The M5A-IL2 immunocytokine (M5A-ICK) combines the cancer targeting features of the M5A antibody with the immune system regulation properties of the cytokine IL-2. Giving M5A-ICK in combination with standard of care (SOC) SBRT may work better in treating patients with unresectable metastatic colorectal cancer or CEA positive metastatic breast cancer.",[27,182],"2026-07-20",{"date":462,"type":39},{"date":486,"type":39},"2025-05-27",{"date":488,"type":22},"2026-09-05",{"name":301,"class":97},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":80,"sex":81,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":507,"locationsCount":47},"100646502","environmental-exposure-assessment-in-high-risk-and-early-onset-breast-cancer-care-100646502","NCT07690852","Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care","Precision Prevention: Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care","Inclusion Criteria:\n\n* AIM 1 INCLUSION CRITERIA:\n\n  * ONE of the following:\n\n    * Either average risk of developing breast cancer (defined by woman with no Tyrer-Cuzick model ≥ 20%, no mention of Tyrer-Cuzick model, and no Pathogenic\u002FLikely Pathogenic \\[P\u002FLP\\] in breast cancer related genes) OR high risk of developing breast cancer (defined by ≥ 20% chance of developing breast cancer across lifetime measured by Tyrer-Cuzick model or gene mutation carrier, P\u002FLP carrier in breast cancer related genes including BRCA1, BRCA2, BARD1, ATM, CHEK2, CDH1, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53) OR early onset breast cancer (defined by a breast cancer diagnosis in a patient younger than 50 years of age)\n  * Age: ≥ 18 years\n  * Speak English or Spanish\n  * Sex: female\n  * Willingness to:\n\n    * Participate in study activities\n    * Permit medical record\u002F clinical laboratory result review\n* AIM 2 INCLUSION CRITERIA\n\n  * Practice at COH (i.e., genetic counselors, geneticists, oncologists, nurse practitioners)\n  * Willingness to:\n\n    * Participate in study activities\n* AIM 3 INCLUSION CRITERIA:\n\n  * Provide written consent\n  * ONE of the following:\n\n    * Either average risk of developing breast cancer (defined by woman with no Tyrer-Cuzick model ≥ 20%, no mention of Tyrer-Cuzick model, and no P\u002FLP in breast cancer related genes) OR High risk: empirical risk of developing breast cancer (defined by ≥ 20% chance of developing breast cancer across lifetime measured by Tyrer-Cuzick model and no P\u002FLP in breast cancer related genes) OR High Risk: gene carrier (defined by P\u002FLP carrier in breast cancer related genes, including BRCA1, BRCA2, BARD1, ATM, CHEK2, CDH1, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53)\n  * Age: ≥ 18 years\n  * Speak English or Spanish\n  * Sex: female\n  * Willingness to:\n\n    * Wear the wristband for 1 week\n    * Participate in study activities\n    * Permit medical record\u002F clinical laboratory result review",{"count":498,"type":22},423,"This study evaluates patient and provider attitudes about environmental exposure risk assessments into clinical care for female patients at average or high risk for breast cancer and\u002For diagnosed with early onset breast cancer.",[27],"2026-07-06",{"date":503,"type":39},"2026-07-08",{"date":505,"type":22},"2026-12-28",{"date":374,"type":22},{"name":301,"class":97},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":81,"minAge":515,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":57,"phases":518,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":225},"100511598","phase-2-acolbifene-versus-low-dose-tamoxifen-for-the-prevention-of-breast-cancer-in-premenopausal-women-at-high-risk-for-development-of-breast-cancer-100511598","NCT05941520","Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer","Phase IIA Trial of Acolbifene (20 mg) vs Low Dose Tamoxifen (5 mg) in Pre-menopausal Women at High Risk for Development of Breast Cancer","Inclusion Criteria:\n\n* Age \\>= 35 years\n* Considered clinically premenopausal\n* Having regular menstrual cycles (between 21 and 35 days) unless a contraceptive device such as progestin containing intrauterine device (IUD) (e.g., Mirena IUD) or oral contraceptives is being used which suppresses menstrual periods, or premenopausal women who have undergone a hysterectomy, but have at least one intact ovary\n* Not considering pregnancy for at least 12 months\n* Women of child-bearing potential capacity who are heterosexually active must be willing to have used effective birth control precautions for 8 weeks prior to fine needle aspiration and be willing to continue for 8 weeks after study completion as tamoxifen may have teratogenic effects on the developing fetus. Reproductive and developmental toxicity studies have not been conducted with acolbifene. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must stop study drug and inform her study physician immediately.\n\n  * For women who are heterosexually active not using oral contraceptive (progestin alone or estrogen plus a progestin), two of the following are recommended but woman must agree to at least one of the following methods:\n\n    * IUD non-hormonal or hormone containing (usually a progestin) intrauterine device (IUD) or rings. Any of these should have been inserted at least 8 weeks prior to RPFNA.\n    * Barrier method (such as condoms and diaphragms or cervical caps with or without a spermicide)\n    * Partner has had a vasectomy.\n  * For women who are heterosexually active using oral contraceptive (progestin alone or estrogen plus a progestin), woman must agree to at least a non- hormonal IUD or a barrier method (below) or her partner must have had a vasectomy:\n\n    * Non-hormonal IUD\n    * Barrier method (such as condoms and diaphragms or cervical caps with or without a spermicide)\n    * Partner has had a vasectomy\n* Must have increased breast cancer risk as predicted by any one or more of the conditions listed below or increased model calculated risk as below:\n\n  * Any one or more of the following conditions associated with increased risk (condition must be documented in electronic medical record or copy of relevant pathology or genetic testing reports submitted with the eligibility checklist)\n\n    * A prior biopsy at any time in the past showing ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), atypical hyperplasia. (If DCIS must have been treated by mastectomy or local excision +\u002F- radiation with this treatment completed at least 3 months prior to screening with RPFNA)\n    * High or moderate penetrance risk pathogenic or likely pathogenic germline gene mutation in ATM, BARD1, BRIP1, CDH1, CHEK2, MSH6, NBN, NF1, PTEN, PMS2, RAD51C, RAD51D, TP53, BRCA2, or PALB2\n    * High polygenic risk score (Life-time risk of \\>= 2x average or 25%)\n    * Breast cancer in a first or second degree relative (female or male) with onset under age 50. First degree relative is defined as parent, sibling, or child. Second degree relative is defined as grandparent, uncle, aunt, nephew, niece, half-sibling, grandchild or first cousin\n    * Two or more affected first or second-degree relatives from either the maternal or paternal lineage without regard to age\n    * Bilateral breast cancer or breast and ovarian cancer in the same first or second degree relative without regard to age.\n    * High mammographic density defined as either visual estimate of area of density (VAS) \\> 50%, or Volpara (Trademark) \\>= 15% dense volume (Volpara d) or Breast Imaging Reporting and Data System (BIRADS) assessment of extremely dense (BIRADs D)\n    * Chest irradiation prior to age 30\n  * Alternatively, instead of conditions listed above, an increased risk of breast cancer as calculated by International Breast Cancer Intervention Study Version 8 (IBIS 8), or Breast Cancer Surveillance Consortium (BCSC) 3 by one or more of the following criteria:\n\n    * 10-year risk of breast cancer of \\>= 3%\n    * Increase in age specific 10-year relative risk by age group\n\n      * Age 35-39 10-year relative risk of \\>= 5X that for age group\n      * Age 40-44 10-year risk of \\>= 4X that for age group\n      * Age 45 and up 10-year risk of \\>= 2X\n    * IBIS Version 8 Remaining lifetime risk of \\>= 25% or \\>= 2X that of population\n  * A copy of the output of model calculations from IBIS 8 (https:\u002F\u002Fems-trials.org\u002Friskevaluator\u002F), or BCSC version 3.0 (https:\u002F\u002Ftools.bcsc-scc.org\u002FBC5yearRisk\u002Fcalculator.htm) online tools, if used for qualifying risk assessment, or polygenetic risk score should be submitted with the eligibility checklist. Otherwise, these risk qualifying factors need to be documented in the medical record if that is considered the source document\n* Women must have at least 1 unaffected untreated breast for fine needle aspiration. Women may have had prior unilateral breast radiation or mastectomy for DCIS\n* Eastern Cooperative Oncology Group (ECOG) current performance status (PS) ≤ 2 as documented within 3 months prior to randomization or Karnofsky score \\>= 60%\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (measured within 180 days prior to randomization)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 1.5 x institutional upper limit of normal (measured within 180 days prior to randomization)\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 1.5 x institutional upper limit of normal (measured within 180 days prior to randomization)\n* Creatinine =\\\u003C 2.0 mg\u002FdL (measured within 180 days prior to randomization)\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n* Ability to understand and the willingness to sign a written informed consent document\n* Confirmation that fixed (Cytolyt™) and frozen tissue specimens have been received in good condition at KUMC and are likely adequate for assessment of the primary endpoint. Confirmation will be provided by Protocol PI(s) and\u002For KUMC Laboratory personnel\n* Confirmation that a Volpara™ Score Card or a Volpara Data Manager (VDM)-generated Excel file has been received at KUMC and archived for assessment of the secondary endpoint. Confirmation will be provided by Protocol PI(s) and\u002For KUMC study coordinator. Alternatively, confirmation may be provided by site personnel that a raw image file in Digital Imaging and Communications in Medicine (DICOM) format has been archived at the site such that it can be later used for generation of a Volpara™ Score Card or Excel file\n\nExclusion Criteria:\n\n* Bilateral breast implants (danger of implant puncture with RPFNA)\n* Women who are pregnant\n* Currently breastfeeding (concern that tamoxifen or acolbifene may be in breast milk) or nursing within the past 12 months (concern about milk fistula with RPFNA)\n* Prior invasive breast cancer within the past 5 years\n* Other prior invasive cancer \\> T1 stage (other than non-melanoma skin) within the past 5 years\n* Pathogenic or likely pathogenic germline mutation in BRCA1\n* Type I or Type II diabetes mellitus requiring treatment with prescription medication\n* Prior deep vein thrombosis, pulmonary embolus, or stroke\n* History of chronic liver disease including NASH (nonalcoholic steatohepatitis) and chronic hepatitis C\n* History of chronic hepatitis B or hepatitis C (danger of exacerbation of liver damage from hepatitis or tamoxifen-induced non-alcoholic fatty liver disease or non-alcoholic steatohepatitis)\n* History of human immunodeficiency virus (HIV)-infection (danger of exacerbation of underlying clinically inapparent liver damage caused by HIV and\u002For hepatotoxicity can be induced by interaction of tamoxifen-induced CYP3A4 with direct anti-hepatitis C virus \\[HCV\\] agents)\n* Current use of prescription anticoagulants such as Coumadin (warfarin), direct-acting oral anticoagulants such as Xarelto (rivaroxaban) or Eliquis (apixaban), or heparin\n* Women who, due to a medical condition, would not be able to discontinue daily use of aspirin (81 mg or higher) and aspirin containing products (81 mg or higher) at least 3 weeks prior to each RPFNA are not eligible\n* Starting or stopping oral contraceptives (OCs) or hormonal progestin IUDs within 8 weeks of baseline RPFNA\n* Current use or use within the prior 8 weeks of progesterone\u002Fprogestin injections or progestin implants (due to concerns about high levels of progestin and lack of safety and efficacy data with low dose tamoxifen)\n* Current use of other investigational agents\n* Prior treatment with acolbifene for more than 2 months\n* Prior treatment with tamoxifen for more than 2 months\n* Current use of prescription immunosuppressive drugs\n* History of allergic reactions attributed to tamoxifen or acolbifene or compounds of similar chemical composition\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study\n* Use of GLP-1 or GIP receptor agonist within 8 weeks of enrollment or plan to use a GLP-1 or GIP receptor agonist during study participation","35 Years",{"count":517,"type":22},80,[86],"This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts. Premenopausal women age 35 or older with a prior diagnosis of atypical hyperplasia, lobular carcinoma in situ, or an estimated 10-year risk of greater than or equal to 3% or estimated 10-year risk of greater than or equal to 2-5 times that of the average woman (depending on age) may be advised to consider five years of standard dose tamoxifen. Standard dose tamoxifen is four times the dose used in this study. Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen blocks the use of estrogen by breast cells. This study may help researchers measure the effects of acolbifene and low dose tamoxifen on markers of breast cancer risk in mammogram imaging, breast tissue, and in blood samples.",[366,27,367,368],"2026-07-03",{"date":523,"type":39},"2026-07-07",{"date":525,"type":39},"2024-10-10",{"date":527,"type":22},"2028-09-01",{"name":45,"class":46},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":81,"minAge":18,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":57,"phases":538,"briefSummary":539,"conditions":540,"keywords":541,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":554},"100494339","phase-2-study-of-aerobic-training-for-people-receiving-treatment-for-breast-cancer-100494339","NCT05716893","Study of Aerobic Training for People Receiving Treatment for Breast Cancer","Phase 2 Trial of Adaptive Versus Standard Dosing of Aerobic Training in Patients Receiving Treatment for Primary Breast Cancer","Inclusion Criteria:\n\n* Aged ≥18 years\n* Female\n* Diagnosed with primary breast cancer as defined by one of the following:\n\n  * Histological confirmation\n  * As per standard of care imaging\n* Scheduled to receive neoadjuvant\u002Fadjuvant systemic and\u002For locoregional therapy\n* Performing ≤90 minutes of moderate- and\u002For strenuous-intensity exercise per week, as evaluated by self-report\n* Willingness to comply with all study-related procedures\n* Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:\n\n  1. Achieving a plateau in oxygen consumption, concurrent with an increase in power output;\n  2. A respiratory exchange ratio ≥ 1.10;\n  3. Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \\[HRmax = 220-Age\\[years\\]);\n  4. Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.\n\nExclusion Criteria:\n\n* Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes\n* Receiving treatment for any other diagnosis of invasive cancer\n* Distant metastatic malignancy of any kind\n* Mental impairment leading to inability to cooperate\n* Any of the following contraindications to cardiopulmonary exercise testing:\n\n  i. Acute myocardial infarction within 3-5 days of any planned study procedures; ii. Unstable angina; iii. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; iv. Recurrent syncope; v. Active endocarditis; vi. Acute myocarditis or pericarditis; vii. Symptomatic severe aortic stenosis; viii. Uncontrolled heart failure; ix. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures; x. Thrombosis of lower extremities; xi. Suspected dissecting aneurysm; xii. Uncontrolled asthma; xiii. Pulmonary edema; xiv. Respiratory failure; xv. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) xvi. Room air desaturation at rest ≤ 85%\n* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation",{"count":537,"type":22},140,[86],"In this study, investigators will compare standard Aerobic Training\u002FAT with adaptive Aerobic Training\u002FAT. Standard AT will be a fixed (unchanging) amount of walking each week, while adaptive AT will adjust the level of exercise depending on participants' response to the exercise. Investigators will see how both study approaches (standard AT and adaptive AT) affect participants' CRF.",[26,27],[321,323,542,543,544,545],"Primary breast cancer","Aerobic Training","22-364","Memorial Sloan Kettering Cancer Center","2026-06-24",{"date":548,"type":39},"2026-06-29",{"date":550,"type":39},"2023-01-30",{"date":552,"type":22},"2028-01-30",{"name":545,"class":97},7,{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":81,"minAge":18,"maxAge":253,"enrollmentInfo":562,"targetDuration":4,"studyType":57,"phases":564,"briefSummary":565,"conditions":566,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":573,"locationsCount":4},"100644613","prediction-of-neoadjuvant-therapy-efficacy-and-prognosis-for-breast-cancer-based-on-multimodal-data-100644613","NCT07671690","Prediction of Neoadjuvant Therapy Efficacy and Prognosis for Breast Cancer Based on Multimodal Data","Prediction of Neoadjuvant Therapy Efficacy and Prognosis for Breast Cancer Based on Multimodal Data: A Multicenter Retrospective and Prospective Validation","Inclusion Criteria:\n\n1. Histopathologically confirmed invasive breast cancer;\n2. Planned to receive a full course of neoadjuvant therapy;\n3. Complete baseline imaging data (MRI\u002Fultrasound\u002Fmammography) and core needle pathology results available.\n\nExclusion Criteria:\n\n1. Previous history of ipsilateral breast cancer or chest radiotherapy;\n2. Distant metastasis (Stage IV);\n3. Poor image quality or missing clinical data exceeding 20%.",{"count":563,"type":22},1800,[59],"This study aims to develop a multimodal deep learning model integrating MRI, ultrasound, digital pathology and clinical information based on multicenter retrospective data. To externally validate the model in an independent prospective cohort, and evaluate its accuracy in predicting pathological complete response (pCR), 3-year and 5-year disease-free survival (DFS). To establish visual tools such as nomograms, assisting clinicians in identifying patients with chemoresistance and facilitating individualized de-escalation or escalation treatment strategies.",[27],"2026-06-22",{"date":569,"type":39},"2026-06-26",{"date":571,"type":22},"2026-06-01",{"date":195,"type":22},{"name":574,"class":97},"Yunnan Cancer Hospital",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":583,"enrollmentInfo":584,"targetDuration":4,"studyType":57,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":352},"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":585,"type":22},120,[59],"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.",[278,279,280,27,589,590],"Breast Inflammatory Carcinoma","Locally Recurrent Breast Carcinoma","2026-06-12",{"date":593,"type":39},"2026-06-15",{"date":595,"type":39},"2026-05-27",{"date":597,"type":22},"2030-04-30",{"name":599,"class":97},"Wake Forest University Health Sciences",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":81,"minAge":18,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":57,"phases":609,"briefSummary":611,"conditions":612,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":47},"100493371","early-phase-1-3d-ultrasound-for-the-imaging-of-lymph-nodes-in-patients-with-breast-cancer-100493371","NCT05704283","3D Ultrasound for the Imaging of Lymph Nodes in Patients With Breast Cancer","3D Ultrasound Imaging of the Axillary Lymph Nodes","Inclusion Criteria:\n\n* Patients with lymph node biopsy or lymph node clip placement as per routine clinical care.\n* Age of 18 or older.\n\nExclusion Criteria:\n\n* Vulnerable subjects such as prisoners and adults lacking capacity to consent.",{"count":608,"type":22},55,[610],"EARLY_PHASE1","This early phase I studies how well a new 3D ultrasound (3D-US) imaging technology works in evaluating lymph nodes in patients with breast cancer. Ultrasound uses high-frequency sound waves to generate images of the body.",[27],{"date":593,"type":39},{"date":615,"type":39},"2023-02-14",{"date":617,"type":22},"2027-06-01",{"name":96,"class":97},{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":47},"100452975","impact-of-dietary-inflammatory-potential-on-breast-cancer-risk-100452975","NCT05178498","Impact of Dietary Inflammatory Potential on Breast Cancer Risk","Longitudinal Study Evaluating the Impact of Dietary Inflammatory Potential on Breast Cancer Risk in a Cohort of Women Followed in the Breast Cancer Prevention Clinic at the Ohio State University Comprehensive Cancer Center- James Cancer Hospital and Solove Research Institute","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Established in the high risk clinic at OSUCCC- James (includes patients with family history of breast cancer \\[BC\\], known genetic predisposition, personal history of known atypia\u002Fbreast lobular carcinoma in situ \\[LCIS\\], or prior chest wall radiation)\n* Patients at high risk for BC established in the surgical oncology clinic at Stefanie Spielman Comprehensive Breast Center (SSCBC), with one of the following diagnoses: Atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS), sclerosing adenosis (SA), or radial scars (RS)\n* Able to read and understand English\n* Able to provide informed consent\n* Must consent to continued follow-up of medical records during the study period\n\nExclusion Criteria:\n\n* Prisoners\n* Not able to speak and understand English\n* Known personal history of ductal carcinoma in situ (DCIS) or Invasive BC",{"count":627,"type":22},960,"This study evaluates the association of dietary inflammatory potential with breast cancer risk. Information collected in this study may help doctors to identify modifiable risk factors, screen high risk patients early, improve prevention strategies, and provide timely intervention for early therapeutic management as needed.",[427,428,27,368,630],"Breast Sclerosing Adenosis","2026-06-10",{"date":591,"type":39},{"date":634,"type":39},"2023-10-25",{"date":636,"type":22},"2035-12-31",{"name":470,"class":97}]