[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1573,0,25,[9,45,75,99,134,153,180,211,236,268,298,330,354,375,395,432,471,494,512,533,562,587,610,628,655],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100652905","effect-of-aromatherapy-on-the-management-of-chemotherapy-induced-neuropathy-cin-100652905",false,"NCT07779135","Effect of Aromatherapy on the Management of Chemotherapy-Induced Neuropathy (CIN)","Effect of Aromatherapy on the Management of Chemotherapy-Induced Neuropathy (CIN) in Patients Receiving Taxane Therapy for Breast Cancer.","AROMA NEUROTAX","Inclusion Criteria:\n\n* Female patients with breast cancer\n* who have painful or bothersome CIN\n* occurring in the context of paclitaxel treatment (during or after treatment)\n* for whom conventional drug treatments provide insufficient relief (or are poorly tolerated or refused).\n* Age ≥ 18 years\n* Who, after receiving information, do not object to the use of their data for the purposes of this research\n\nExclusion Criteria:\n\n* Pre-existing neuropathy (e.g., due to diabetes)\n* Known allergy to an essential oil or a component of essential oils (e.g., linalool)\n* Presence of wounds on the affected areas\n* Refusal to use aromatherapy\n* Inability to complete the questionnaires","FEMALE","18 Years",{"count":21,"type":22},80,"ESTIMATED","OBSERVATIONAL","The main objective of this study is to describe the effect of an essential oil-based blend applied topically in the management of painful symptoms, sensory disturbances, or functional impairment caused by Chemotherapy-Induced Neuropathy (CIN) in breast cancer patients who have undergone paclitaxel treatment.",[26,27],"Breast Cancer","Neuropathic Pain in Cancer",[29,30,31],"Chemotherapy-Induced Neuropathy","Breast cancer","Aromatherapy","RECRUITING","2026-08-20",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":36},"2026-07-15",{"date":40,"type":22},"2027-09-15",{"name":42,"class":43},"Centre Hospitalier de Colmar","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":44},"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","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","120 Years",{"count":55,"type":22},139,"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.",[26,58,59,60],"Breast Carcinoma","Cancer of the Breast","Malignant Neoplasm of Breast",[62,63,64,65],"Triple Negative Breast Cancer (TNBC)","HER2-Postitive","Metastatic Breast Cancer","Cerebral Spinal Fluid Collection","NOT_YET_RECRUITING",{"date":35,"type":36},{"date":69,"type":22},"2026-08-26",{"date":71,"type":22},"2034-07-01",{"name":73,"class":74},"National Cancer Institute (NCI)","NIH",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":53,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":44},"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":83,"type":22},175,"INTERVENTIONAL",[86],"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.",[26,58,59,60],[90,62,91,92],"ENLIGHT","Her2","NSR device",{"date":35,"type":36},{"date":95,"type":36},"2026-02-23",{"date":97,"type":22},"2029-08-04",{"name":73,"class":74},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":106,"enrollmentInfo":107,"targetDuration":109,"studyType":23,"phases":4,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100652772","axillary-web-syndrome-after-breast-cancer-surgery-incidence-risk-factors-and-functional-outcomes-100652772","NCT07780240","Axillary Web Syndrome After Breast Cancer Surgery: Incidence, Risk Factors, and Functional Outcomes","A Prospective Multicenter Cohort Study on the Incidence, Risk Factors, and Postoperative Functional Outcomes of Axillary Web Syndrome After Breast Cancer Surgery","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of breast cancer with planned surgical treatment\n* Axillary staging performed by sentinel lymph node biopsy or axillary lymph node dissection\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Preoperative restriction of shoulder range of motion\n* History of neuromuscular disease affecting the upper extremity\n* Metastatic disease\n* Anticipated inability to comply with the follow-up protocol","80 Years",{"count":108,"type":22},250,"6 Months","Axillary web syndrome (AWS), sometimes called \"cording,\" is a condition that can develop after breast cancer surgery in which the lymph nodes under the arm are removed or sampled. It appears as one or more tight, painful cord-like structures running from the armpit down the inner arm. It can limit shoulder movement, cause pain, and interfere with daily activities.\n\nIt is not yet clear how often AWS occurs, when it typically appears after surgery, which patients are most likely to develop it, or whether it is related to the arm swelling (lymphedema) that some patients experience after breast cancer treatment. Most previous studies looked back at patient records rather than following patients forward in time, so the answers remain uncertain.\n\nIn this study, women who are having breast cancer surgery with either sentinel lymph node biopsy or axillary lymph node dissection will be examined before their operation and then at set times afterward: 2, 4, and 8 weeks, and 3 and 6 months. At each visit, the study doctor will examine the armpit and arm for cords, measure how far the shoulder can move, ask the patient to rate any pain, and measure the circumference of both arms to check for swelling.\n\nThe study does not change the surgery or treatment a patient receives. It adds only these examinations and measurements, which are not painful and do not require blood tests or imaging. The researchers hope the results will help identify which patients are at higher risk, so that rehabilitation can be started earlier.",[112,26,113,114],"Axillary Web Syndrome","Breast Cancer Lymphedema","Postoperative Complications",[116,117,118,119,120,121,122,123,124],"axillary web syndrome","cording","lymphatic cording","sentinel lymph node biopsy","axillary lymph node dissection","shoulder range of motion","breast cancer surgery","postoperative morbidity","prospective cohort","2026-08-19",{"date":35,"type":36},{"date":128,"type":36},"2026-05-01",{"date":130,"type":22},"2027-10",{"name":132,"class":43},"Antalya City Hospital",2,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":84,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":44},"100652659","application-of-ct-linac-based-all-in-one-one-stop-radiotherapy-in-breast-cancer-100652659","NCT07776301","Application of CT-Linac-Based \"All-in-One\" One-Stop Radiotherapy in Breast Cancer","Application of CT-Linac-Based \"All-in-One\" One-Stop Radiotherapy in All-Scenario Breast Cancer Radiotherapy: A Prospective Clinical Study","Inclusion Criteria:\n\n* Histologically or pathologically confirmed breast cancer with definitive indications for radiotherapy (preoperative, postoperative, or radical)\n* ECOG performance status of 0-2\n* Able to remain still and supine on the treatment couch for up to 30 minutes\n* Provision of signed, written informed consent\n* Able to comply with daily follow-ups and blood sample collections\n\nExclusion Criteria:\n\n* Palliative radiotherapy for concurrent distant metastasis\n* Incomplete or ongoing chemotherapy\n* Synchronous multiple primary tumors\n* Current pregnancy or lactation\n* Prior history of radiotherapy to the ipsilateral breast, chest wall, thorax, or regional lymph nodes\n* Severe non-malignant comorbidities (e.g., cardiovascular or pulmonary diseases, systemic lupus erythematosus, scleroderma) resulting in a short life expectancy or inability to tolerate radical radiotherapy\n* Inability or unlikelihood to comply with study follow-up\n* Inability or unwillingness to provide written informed consent",{"count":142,"type":22},225,[86],"This study aims to evaluate and report the clinical adverse events and dosimetric parameters in breast cancer patients undergoing an \"all-in-one (AIO)\" one-stop, fully automated radiotherapy workflow. By systematically tracking these clinical and physical metrics, we seek to establish a standardized clinical protocol for AIO radiotherapy in breast cancer management.",[26],{"date":33,"type":36},{"date":148,"type":36},"2021-08-27",{"date":150,"type":22},"2028-11-27",{"name":152,"class":43},"Fudan University",{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":84,"phases":163,"briefSummary":164,"conditions":165,"keywords":170,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":44},"100643509","autologous-fat-grafting-for-total-breast-reconstruction-in-irradiated-breast-cancer-patients-100643509","NCT07641985","Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients","Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Patients","AFT-R","Inclusion Criteria:\n\n* Female, aged \\>18 years.\n* BMI between \\> 22 and \\\u003C35 kg\u002Fm2\n* History of breast cancer treated with mastectomy (minimally 3 months after mastec-tomy) and post mastectomy chest wall radiotherapy (completed ≥6 months before en-rollment).\n* May include contralateral\u002Fbilateral prophylactic mastectomy if at least one side had cancer and radiation.\n* Desires autologous breast reconstruction and accepts randomization between AFT and DIEP.\n* Medically fit for surgery (ASA I-III).\n* Sufficient donor tissue for both AFT (enough fat) and DIEP (suitable abdominal tissue and vasculature).\n* No evidence of active cancer at enrollment; remission confirmed.\n* Able to wear the EVE device (if randomized in AFT).\n* Capable of understanding study information and questionnaires (Dutch or English), willing to give informed consent, and able to comply with follow-up.\n\nExclusion Criteria:\n\n* Prior autologous breast reconstruction on the intended side. BMI \\\u003C22 or \\>35 kg\u002Fm2\n* Contraindication to DIEP flap (e.g., prior abdominoplasty or abdominal scars affecting perforators).\n* Contraindication to AFT (e.g., insufficient fat or conditions impairing fat graft viability).\n* Current chemotherapy or completed less than 4 weeks prior to enrollment.\n* Serious uncontrolled comorbidities making elective surgery unsafe (e.g., unstable heart disease, severe coagulopathy, end-stage organ failure).\n* Active smoker or not abstinent for at least 6 weeks pre-operatively.\n* Pregnant at time of enrollment.\n* In case low compliance is expected or an inability to comply with study protocol, including unwillingness to undergo either AFT or DIEP, or inability to complete follow-up (due to language, cognitive issues, or relocation plans).\n* Previous enrollment in this trial (patients can only be included once, even if later presenting for contralateral reconstruction).\n* Allergy to lidocaine or silicone",{"count":162,"type":22},280,[86],"The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following mastectomy. It will also evaluate patient satisfaction, quality of life, complication rates, and cost-effectiveness of both reconstruction techniques. The main questions it aims to answer are:\n\nDoes AFT result in non-inferior patient satisfaction with the reconstructed breast compared to DIEP flap reconstruction 12 months after the final operation? Does AFT result in fewer major complications and improved cost-effectiveness compared to DIEP flap reconstruction? Are quality of life outcomes and oncologic safety comparable between AFT and DIEP flap reconstruction in irradiated patients?\n\nResearchers will compare AFT to DIEP flap reconstruction to see if AFT can provide similar reconstructive outcomes with lower morbidity and fewer complications in irradiated breast cancer patients.\n\nParticipants will:\n\nUndergo breast reconstruction using either AFT or DIEP flap reconstruction Attend follow-up visits for clinical examinations, imaging, and assessment of complications Complete questionnaires about breast satisfaction, quality of life, and recovery during follow-up Be monitored for oncologic safety and reconstructive outcomes for 12 months after the final operation",[26,166,167,168,169],"Breast Reconstruction","Breast Reconstruction After Mastectomy","Breast Cancer Radiation","Lipofilling",[169,171,172],"Breast reconstruction","Irradiated patients",{"date":35,"type":36},{"date":175,"type":36},"2026-07-01",{"date":177,"type":22},"2032-07-01",{"name":179,"class":43},"Maastricht University Medical Center",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":189,"conditions":190,"keywords":200,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":44},"100633240","study-of-high-precision-evaluation-of-molecular-residual-disease-through-a-platform-for-cancer-tracking-and-interception-sherlock-100633240","NCT07524114","Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception (SHERLOCK)","SHERLOCK","Inclusion Criteria:\n\n1. Patients with histopathological confirmation of cancer. Patients whose diagnosis are made by cytology may also be considered for this study. For tumor types that are typically diagnosed using unequivocal imaging findings or biomarker profiles (e.g. hepatocellular cancer, uveal melanoma), they can be eligible without histopathological or cytological confirmation.\n2. Patients must have cancer that is planned for or has undergone curative intent treatment (e.g. surgery, definitive radiation, definitive chemoradiation, adjuvant radiation, adjuvant chemotherapy, adjuvant chemoradiation, etc). Curative intent treatment must be completed within 12 months of study entry. For patients on adjuvant\u002Fmaintenance endocrine or biological therapy (e.g. bevacizumab, immunotherapy, etc), enrollment within 12 months of completion of curative intent treatment is allowed.\n3. Patient must be ≥ 18 years old.\n4. All patients must have signed and dated an informed consent form.\n\nExclusion Criteria:\n\n1\\. History of another active invasive cancer within 2 years prior to study enrolment. Exceptions include squamous and basal cell carcinoma of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, is considered cured with minimal risk of recurrence within 2 years.",{"count":188,"type":22},7000,"This study will collect, annotate, and sequence biospecimens (blood, tissue, urine, saliva and surgery drainage) from patients across different cancer types to detect molecular residual disease (MRD). Imaging scans and clinical data will also be gathered. This will allow for early cancer interception, and hopefully prolong relapse-free survival across tumor types. Results of ctDNA testing will be provided for clinical decisions and to determine eligibility for other linked interventional interception therapeutic studies, each of which will have a separate protocol.",[26,191,192,193,194,195,196,197,198,199],"Lung Cancer","Melanoma","Gynecologic Cancer","Genitourinary Cancer","Pancreatobiliary Cancer","Gastrointestinal Cancer","Head and Neck Cancer","Rare Cancer","Unknown Primary Tumors",[201,202,203],"Minimal Residual Disease","Liquid Biopsy","Circulating Tumor DNA",{"date":35,"type":36},{"date":206,"type":36},"2026-03-31",{"date":208,"type":22},"2031-03-31",{"name":210,"class":43},"University Health Network, Toronto",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":84,"phases":219,"briefSummary":221,"conditions":222,"keywords":225,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":235},"100628287","phase-2-herizon-breast-a-ctdna-guided-adaptive-study-of-sequential-anti-her2-therapies-and-cns-prophylaxis-to-induce-long-term-remission-100628287","NCT07459673","HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission","Inclusion Criteria:\n\n* Male or female participants who are ≥18 years old with histologically confirmed diagnosis of unresectable locally advanced or MBC.\n* Stage IV at the diagnosis (i.e., de novo metastatic) as per AJCC 8.\n* HER2 IHC results of 3+.\n* Life expectancy of ≥12 weeks.\n* Must be deemed medically fit for surgery and be surgical candidates upfront, or potentially operable if there is response to induction therapy.\n* Must have measurable disease per PERCIST 1.0.\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 14 days prior to the start of study intervention.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), as described in Appendix 3 during the intervention period. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n  * A WOCBP must have a negative urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of beta-human chorionic gonadotropin \\[β-hCG\\]) within 72 hours before the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n  * Additional requirements for pregnancy testing during and after study intervention are located in Appendix 2.The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n  * Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of therapy.\n  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n* Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n* Criteria for known Hepatitis B and C positive subjects: Hepatitis B and C screening tests are required as per MSK policy but do not need to be repeated prior to study unless there is a known history of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.\n* Participants who have active hepatitis B infection (defined as HBsAg positive and\u002For detectable HBV DNA) are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Participants should remain on anti-viral therapy throughout study intervention and follow MSK guidelines for HBV anti-viral therapy post completion of study intervention.\n* Participants with a history of HCV infection (defined as anti-HCV Ab positive and detectable HCV RNA) are eligible if HCV viral load is undetectable at screening.\n* Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\nTable 1 Adequate Organ Function Laboratory Values Hematological Absolute neutrophil count (ANC): ≥1500\u002FµL Platelets: ≥100 000\u002FµL Hemoglobin: ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL\n\nRenal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × ULN\n\nHepatic Total bilirubin: ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN AST (SGOT) and ALT (SGPT)\n\nCoagulation\n\nInternational normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT):\n\n≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. a Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. b Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.\n\nExclusion Criteria:\n\n* Patients diagnosed with HER2+ breast cancer as per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines with HER2 IHC results of 1-2+ and positive FISH or ISH\n* Prior exposure to anti-HER2 therapy of any kind or any systemic anti-cancer treatment of any kind for breast cancer.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 2 weeks prior to the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses \\>10 mg daily of oral prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Inhaled, intranasal, intra-articular, or topical steroid use are allowed.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, which have undergone potentially curative therapy are not excluded.\n* Has known CNS metastases and\u002For leptomeningeal carcinomatosis.\n* Has a history or evidence of active pneumonitis or interstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has grade \\>=3 neuropathy of any etiology.\n* Has an active infection requiring antibiotics.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection.\n* Has an inability to swallow capsules or tablets.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Has significant cardiovascular impairment within 12 months of the first dose of study drug: such as NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted.\n* Has a left ventricular ejection fraction (LVEF) below the institutional normal range of 50%, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).\n* Known intolerance to any of the study drugs (or any of the excipients).\n* Has had major surgery within 3 weeks prior to first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.",{"count":218,"type":22},60,[220],"PHASE2","Thie purpose of this study is to find out whether a personalized treatment approach-using a series of ctDNA tests along with standard imaging scans to help decide when to step up (escalate) or decrease (de-escalate) sequential treatments (given one after another)-combined with local therapies (which treat cancer in a specific part of the body) and treatments that prevent cancer from spreading to the central nervous system (CNS; including the brain and spinal cord) can result in long-lasting remission and possibly cure some participants with HER2+ metastatic breast cancer.",[26,223,224],"HER2-positive Breast Cancer","Breast Cancer Stage IV",[226,223,224,227,228],"breast cancer","Memorial Sloan Kettering Cancer Center","25-258",{"date":33,"type":36},{"date":231,"type":36},"2026-03-04",{"date":233,"type":22},"2030-03-04",{"name":227,"class":43},7,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":52,"minAge":243,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":84,"phases":246,"briefSummary":247,"conditions":248,"keywords":254,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":44},"100610399","dosing-physical-activity-among-older-cancer-survivors-who-experience-chronic-pain-a-micro-randomized-trial-100610399","NCT07227077","Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial","An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial","Inclusion Criteria:\n\n1. Age greater than or equal to 65 years.\n2. Patients with a history of bladder, breast, cervical, colorectal, endometrial, lung, and prostate cancer diagnosis and treatment.\n3. Fluent in spoken and written English.\n4. Patient has access to smartphone\n5. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Patient has metastatic disease.\n2. Patient has cancer recurrence.","65 Years",{"count":245,"type":22},50,[86],"The purpose of this study is to assess the best time to deliver a message to increase physical activity and how often participants will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.",[26,249,250,251,252,191,253],"Cervical Cancer","Bladder Cancer","Colorectal Cancer","Endometrial Cancer","Prostate Cancer",[255,256,257,258,259,260],"Physical Activity","Exercise","Survivorship","Supportive Care","Pain","Symptom Management",{"date":33,"type":36},{"date":263,"type":36},"2026-02-07",{"date":265,"type":22},"2027-05-01",{"name":267,"class":43},"Medical College of Wisconsin",{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":84,"phases":276,"briefSummary":278,"conditions":279,"keywords":285,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":297},"100601379","phase-1-a-phase-12-trial-of-ter-2013-in-patients-with-solid-tumors-harboring-aktpi3kpten-pathway-alterations-100601379","NCT07109726","A Phase 1\u002F2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT\u002FPI3K\u002FPTEN Pathway Alterations","Key Inclusion Criteria\n\n* Metastatic or locally advanced, unresectable disease\n* No available treatment with curative intent\n* Presence of lesions to be evaluated per RECIST v1.1:\n\n  a. Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ function\n* Advanced solid tumor malignancy harboring an eligible AKT\u002FPI3K\u002FPTEN pathway alteration detected by a sponsor approved test\n\nKey Inclusion Criteria for TER-2013 monotherapy arms:\n\n* Histologically confirmed diagnosis of:\n\n  a. \\[For TER-2013 dose escalation\\]: solid tumor malignancy b. \\[For TER-2013 cohort expansion\\]: i. Cohort 1: ovarian cancer, cervical cancer, or squamous cell carcinoma of the head and neck, lung, or esophagus ii. Cohort 2: endometrial adenocarcinoma\n* Prior therapy:\n\n  1. \\[For TER-2013 dose escalation\\]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused\n  2. \\[For TER-2013 cohort expansion\\]: No more than 3 prior lines of treatment in the advanced setting\n\n     Key Inclusion Criteria for TER-2013 and fulvestrant combination arms\n* Histologically confirmed diagnosis of:\n\n  a. \\[For TER-2013 + fulvestrant dose escalation\\]: HR+\u002FHER2- advanced unresectable or metastatic breast cancer b. \\[For TER-2013 + fulvestrant cohort expansion\\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting\n* Prior Therapy:\n\n  a. \\[For TER-2013 + fulvestrant dose escalation\\]: Received treatment with an AI containing regimen (single agent or in combination) b. \\[For TER-2013 + fulvestrant cohort expansion\\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting\n\nKey Exclusion Criteria:\n\n* Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K\u002FAKT\u002FPTEN alteration\n* Clinically significant abnormalities of glucose metabolism\n* Active brain metastases or carcinomatous meningitis.\n* History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug\n* Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to interfere with the delivery, absorption, or metabolism of TER-2013\n* Prior therapy:\n\n  1. \\[For TER-2013 monotherapy escalation\\]: AKT inhibitor\n  2. \\[For TER-2013 monotherapy expansion\\]: AKT\u002FPI3K\u002FPTEN pathway inhibitor\n  3. \\[For TER-2013 + fulvestrant combination expansion\\]: AKT\u002FPI3K\u002FPTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria apply",{"count":275,"type":22},205,[277,220],"PHASE1","This is a Phase 1\u002F2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT\u002FPI3K\u002FPTEN pathway alterations.",[26,252,280,281,282,283,284,249],"Ovarian Cancer","Lung Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma","Esophageal Squamous Cell Carcinoma","Solid Tumor",[286,26,287,288],"AKT\u002FPI3K\u002FPTEN Alterations","Advanced Solid Tumors","HR+\u002FHER2-",{"date":35,"type":36},{"date":291,"type":36},"2025-09-23",{"date":293,"type":22},"2029-02-28",{"name":295,"class":296},"Terremoto Biosciences Inc.","INDUSTRY",18,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":306,"targetDuration":308,"studyType":23,"phases":4,"briefSummary":309,"conditions":310,"keywords":317,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":329},"100599511","audit-of-targeted-sentinel-node-biopsy-tsnb-in-patients-with-limited-nodal-disease-undergoing-primary-surgery-100599511","NCT07085442","Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery","NodeSMART - Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery","NodeSMART","Inclusion Criteria:\n\n* cT1-2N1M0 breast cancer\\*\n* FNA or core biopsy confirmed axillary nodal metastases\n* ≤2 abnormal nodes on imaging\n* Undergo a dual tracer or single tracer sentinel node biopsy along with removal of the marked node (Targeted Sentinel Node Biopsy, TSNB)\n* 1 or 2 macrometastases identified in the removed nodes, with at least three nodes removed\n* If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if 1 or 2 macrometastases are identified in the removed nodes, with at least three nodes removed.\n* If the node is not marked or the marked node is not removed, the patient will be eligible if 1 or 2 macrometastases are identified in the removed nodes, with at least three nodes removed.\n\n  * patients with T3 tumours on post-operative histology will remain eligible. For multifocal\u002Fmulticentric tumours, the T stage is based on the size of the largest invasive tumour focus rather than the combined size of all tumours.\n\nExclusion Criteria:\n\n* Neoadjuvant chemotherapy\n* Previous ipsilateral axillary lymph node dissection\n* cT3-4 breast cancer\n* ≥3 abnormal nodes on imaging",{"count":307,"type":22},300,"5 Years","Axillary ultrasound scan (AUS) is routinely employed in the UK for preoperative axillary staging and can diagnose approximately 50 - 80% of node positive patients when combined with percutaneous needle biopsy techniques (either core-biopsy or fine-needle aspiration cytology). It is recognised that nodal burden is generally higher in clinically node negative patients with abnormal nodes on AUS and confirmed on needle-biopsy to be histologically positive than patients diagnosed as node positive on sentinel node biopsy (SNB). However, up to 40% of biopsy-proven node positive patients are found to have fewer than 3 involved nodes on subsequent axillary lymph node dissection (ALND) and are potential candidates for less extensive axillary surgery with axillary radiotherapy (ART) rather than ALND. The total number of abnormal nodes on ultrasound is a key predictor of overall nodal tumour burden.\n\nThe AMAROS and OTOASOR trials randomised patients with up to 2 positive sentinel nodes to either ALND or ART. These trials were conducted around the turn of the millennium and before routine use of AUS and therefore would have included a significant number of patients who were radiologically node positive (cN1). Likewise, the ACOSOG Z0011 trial that randomised a similar group of patients to either ALND or observation only, did not incorporate routine AUS and would have included some (radiological) cN1 patients. These trials revealed no adverse impact on disease-free or overall survival from omission of completion ALND.\n\nTargeted axillary dissection (TAD) was introduced a few years ago to reduce the false negative rate of SNB following neoadjuvant chemotherapy (NACT) and has been standardised as part of the ongoing ATNEC trial \\[ClinicalTrials.govNCT04109079\\]. This technique for axillary staging after NACT is increasingly being adopted in the UK and elsewhere. TAD is technically more straightforward and less challenging in patients undergoing primary surgery with no concerns about clip migration consequent to nodal shrinkage as part of treatment response to NACT. Furthermore, the risk of under-treating the axilla is offset by the protocol: if no disease is identified in the targeted nodes (false-negative case), then patients proceed to ALND, thereby ensuring adequate treatment. Unlike TAD following NACT, the presence of viable tumour within the sampled nodes is mandatory and finding fibrosis is irrelevant except as a response to nodal biopsy per se.\n\nCurrent ASCO guidelines support both SNB and TAD as staging options for patients with ultrasound-detected, biopsy-confirmed nodal disease. The Edinburgh randomised trials comparing four-node sampling with ALND demonstrated significantly lower arm morbidity with node sampling, supporting TAD as a less morbid appropriate alternative in this patient population.\n\nThe UK-ANZ POSNOC trial randomised 1,900 patients with \\\u003C3 macrometastases to either no further axillary treatment or additional axillary treatment. The study included cN1 patients with biopsy-confirmed nodal metastases who underwent sentinel node biopsy or TAD. Patients with \\\u003C3 macrometastases on final histology were randomised to receive no further axillary treatment or proceed with additional axillary treatment (ALND or ART). POSNOC trial will answer whether further axillary treatment provides any benefit in patients with low volume nodal disease on SNB or TAD.\n\nNotably, patients with biopsy-confirmed metastases and \\\u003C3 macrometastases on SNB\u002FTAD are biologically and clinically similar to patients with normal AUS who are later found to have low-volume disease on SNB. Clinical decision-making and patient outcomes are driven by tumour biology and overall disease burden rather than the method of nodal disease detection. Furthermore, AUS sensitivity is operator dependent and whether FNA or core biopsy was used to sample the node. A patient considered node negative on AUS by one radiologist may be diagnosed with core biopsy confirmed nodal metastases with another radiologist. Pending the results of POSNOC trial, patients with less than 3 macrometastases are generally advised further axillary treatment, and ART is preferred over ALND to reduce the risk of lymphoedema.\n\nNodeSMART is a prospective audit collecting data on patients undergoing TAD in the primary surgery setting. Its goal is to audit surgical outcomes and benchmark them against - a) Comparing technical outcomes with those from sentinel node biopsy in the primary surgery setting and TAD performed after neoadjuvant chemotherapy. b) Assessing rates of arm lymphoedema and disease progression relative to findings from the AMAROS and Z11 trials, and the POSNOC trial once results are available. The term \"Targeted Axillary Dissection\" is somewhat misleading in this context, as the marked (biopsied) node is removed alongside sentinel nodes - not in isolation. NodeSMART therefore refers to the procedure more accurately as Targeted Sentinel Node Biopsy (TSNB).",[26,311,312,313,314,315,316],"Axillary Lymph Nodes Dissection","Axillary Metastases","Sentinel Lymph Node Biopsy (SLNB)","Node Positive Breast Cancer","Axilla; Breast","Axillary Ultrasound",[318,319,304,26,320,311,321],"Targeted Axillary Dissection","Targeted Sentinel Node Biopsy","Sentinel Node Biopsy","Axillary Node Clearance",{"date":33,"type":36},{"date":324,"type":36},"2025-01-17",{"date":326,"type":22},"2032-12",{"name":328,"class":43},"University Hospitals of Derby and Burton NHS Foundation Trust",12,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":84,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":353},"100575644","phase-1-a-phase-1-study-of-lncb74-in-advanced-solid-tumors-100575644","NCT06774963","A Phase 1 Study of LNCB74 in Advanced Solid Tumors","A Phase 1, Open-label, Dose Escalation and Dose Expansion Study for LNCB74, a B7-H4 Targeted Antibody Drug Conjugate, as Monotherapy in Participants With Advanced Solid Tumors","LNCB74-01","Inclusion Criteria:\n\n1. The participant provides written informed consent\n2. ≥ 18 years of age on day of signing informed consent.\n3. Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and\u002For metastatic solid tumors\n4. A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child\n5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential\n6. Have measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology\n7. Able to provide tumor tissue sample.\n8. Willing to undergo fresh tumor biopsy at Screening and On-treatment if archival tissue not available\n9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n10. Life expectancy greater than or equal to 12 weeks as judged by the Investigator.\n11. Have adequate organ function\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to treatment.\n2. Has received prior investigational agents within 4 weeks prior to treatment.\n3. Has received anti-cancer chemotherapy (Immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy within 2 weeks prior to treatment.\n4. Has received antibody-based anti-cancer therapy within 4 weeks prior to treatment.\n5. Has received targeted agents and small molecules within 2 weeks or 5 half-lives, whichever is longer.\n6. Has received prior platinum-based chemotherapy and progressed within 4 weeks of initiating therapy (platinum-refractory disease)\n7. Has received an ADC with MMAE payload.\n8. Has received prior radiotherapy within 2 weeks of start of study treatment for focal radiation or within 4 weeks for wide-field radiotherapy\n9. Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.\n10. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.\n11. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n12. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n13. Has known active CNS metastases and\u002For carcinomatous meningitis\n14. Has severe hypersensitivity (≥ Grade 3), known allergy or reaction LNCB74 or any of its excipients.\n15. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease.\n16. Has active ≥Grade 2 sensory or motor neuropathy.\n17. Has active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy or any clinically significant corneal disease.\n18. Has an active infection requiring systemic therapy.\n19. Any major surgery within 4 weeks of study drug administration.\n20. Toxicity (except for alopecia) related to prior anti-cancer therapy and\u002For surgery, unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.\n21. Prior organ or tissue allograft.\n22. Uncontrolled or significant cardiovascular disease\n23. Participants with serious or uncontrolled medical disorders.\n24. Participants who are on total parenteral nutrition (TPN)\n25. Participants with history of bowel obstruction within one month of screening\n26. Participants with history of significant ascites requiring paracentesis within 2 weeks of screening\n27. Has a known history of human immunodeficiency virus (HIV) infection with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count \\\u003C350 cells\u002Fµl\n28. Has known active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection\n29. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study\n30. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study",{"count":339,"type":22},145,[277],"This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and \u002F or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors.",[280,26,252,343,344,345],"Biliary Tract Cancer","Non-Small Cell Lung Cancer","Advanced or Metastatic Solid Tumors",{"date":35,"type":36},{"date":348,"type":36},"2025-01-07",{"date":350,"type":22},"2026-12",{"name":352,"class":296},"NextCure, Inc.",14,{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":84,"phases":364,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":44},"100557343","gut-microbiome-adverse-effects-and-markers-through-metabolic-reprogramming-100557343","NCT06536881","Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming","Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming (GAMMER) Study in Early Stage Breast Cancer Receiving Chemotherapy","GAMMER","Inclusion Criteria:\n\n* Diagnosed with histologically-confirmed stage I-III invasive carcinoma of the breast\n* Planning for standard neoadjuvant or adjuvant chemotherapy ddAC or TC for 4 cycles (concurrent anti-HER2 therapy is permitted)\n* Provider physical exam within 4 weeks of consent\n* Eastern Cooperative Oncology Group (ECOG) 0-1 (as per recent provider note or direct confirmation with provider)\n* BMI ≥ 19.5 kg\u002Fm2 (as per most recent visit documented in medical record)\n* Willingness to change diet, and provide fecal sample 3 times during study\n\nExclusion Criteria:\n\n* BMI \\\u003C19.5 kg\u002Fm2\n* Diabetes\n* History of eating disorder\n* Serious\u002Funcontrolled medical condition (e.g. end stage renal disease on dialysis, cirrhosis, uncontrolled hypertension, seizure disorder, history of bariatric surgery)\n* Pregnant or nursing\n* Use of medications that must be taken with food: allopurinol, aspirin, amiodarone, baclofen, bromocriptine, carvedilol, carbamezpine, cimetidine, diclofenac, doxycycline, fenofibrate, fludrocortisone, glyburide, hydrocortisone, iron supplements, ketorolac, lithium, methylprednisolone, naproxen, niacin, potassium salts, prednisone, procainamide, sevelamer, sulfasalazine, trazodone, valproic acid",{"count":363,"type":22},30,[86],"This research is being done to test the feasibility of 24-48 hours of water-only fasting to improve delivery of 4 cycles of chemotherapy in those receiving breast cancer treatment either before or after surgery.",[26,367],"Early-stage Breast Cancer",{"date":35,"type":36},{"date":370,"type":36},"2024-08-08",{"date":372,"type":22},"2029-05",{"name":374,"class":43},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":84,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":44},"100550040","phase-2-bre-10-biomarker-optimization-of-neoadjuvant-therapy-in-breast-cancer-100550040","NCT06441890","BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer","BRE-10: BIomarker OptimizatioN of NeOadjuVAnt Therapy in BrEast Cancer: The INNOVATE Trial","BRE-10","Inclusion Criteria:\n\n* Age ≥ 18 years of age at time of consent\n* ECOG performance status 0, 1, or 2\n* Histologically confirmed invasive breast cancer documented by core needle or surgical biopsy with 90 days prior to study registration.\n* HER2-positive by IHC or FISH according to ASCO\u002FCAP 2018 guidelines\n* HER2-enriched subtype on the MammaPrint\u002FBluePrint gene expression profile within 90 days prior to study registration.\n* Curative resection of primary breast tumor(s) is planned; ipsilateral axillary nodes will be sampled by sentinel lymph node biopsy or axillary dissection\n* Treating Oncologist recommends neoadjuvant chemotherapy\n* No evidence of distant metastatic disease\n* AJCC clinical stage: cT1c-T3, cN0-N2\n* Baseline left ventricular ejection fraction (LVEF) of at least 50% on Echo or MUGA scan within 90 days prior to registration.\n\nAdequate organ function as defined below:\n\nLeukocytes ≥2,000\u002Fmm3 Platelet count ≥ 75,000\u002Fmm3 Absolute Neutrophil Count (ANC) ≥ 1,000\u002Fmm3 Hemoglobin (Hgb) ≥ 9.0 g\u002FdL Creatinine\u002FCalculated Creatine clearance (CrCI) Cr \\\u003C 1.5 x upper limit of normal (ULN) or CrCl ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin \\> 1.5 × ULN, if no evidence of biliary obstruction exists Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n\n* Patients with synchronous bilateral primary breast tumors or multiple ipsilateral primary breast tumors are eligible if the treating Oncologist determines that the assigned treatment regimen is appropriate therapy for all primary tumors requiring chemotherapy.\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. or the Legally Authorized Representative (LAR) is able to provide consent and HIPAA authorization.\n* Women of childbearing potential must agree to use a barrier form of contraception if they are sexually active with a male partner and cannot be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n* As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n* Patients with history of HIV\u002FAIDS (acquired immunodeficiency syndrome) are eligible for this study if they are receiving anti-retroviral therapy and it does not include any medications known to alter metabolism or tolerability of component drugs in the protocol treatment regimen and the following criteria is met:\n\n  \\- Patients without a history of AIDS-defining opportunistic infections within the past 12 months.\n* Patients with Hepatitis B (HBV): chronic carriers of HBV infection (HBsAg-positive) or individuals who have serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and anti-HBc-positive) are eligible if they are receiving appropriate suppressive antiviral therapy that does not include medications known to alter metabolism or tolerability of component drugs in the protocol treatment (see Appendix) prior to initiation of cancer therapy, and liver function tests meet study eligibility criteria.\n* Patients with Hepatitis C (HCV): patients with a history of HCV infection who have completed curative antiviral treatment are eligible if the HCV RNA viral load is below the limit of quantification within 90 days of study enrollment. Patients on concurrent HCV treatment must have HCV RNA viral load below the limit of quantification within 30 days of study enrollment. Patients must also meet liver function test eligibility requirements and antiviral therapy does not include medications known to alter metabolism or tolerability of component drugs in the protocol treatment\n\nExclusion Criteria\n\n* Any prior therapy for this breast cancer\n* Active infection requiring systemic therapy at the time of study registration\n* Pregnant or nursing\n* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.\n* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.\n* Other major comorbidity (e.g., compromised liver function, major cardiovascular or cerebrovascular event within the past 6 months, uncontrolled diabetes mellitus or hypertension), as determined by treating physician.\n* Any contraindication for any chemotherapy drug used in the assigned regimen.\n* Baseline sensory neuropathy \\> grade 1\n* History of hypersensitivity to any of the drugs in the treatment regimen. Patients with history of hypersensitivity may be treated on this protocol with either nab-paclitaxel or docetaxel.\n* Prisoners",{"count":384,"type":22},28,[220],"Adult men and women with early-stage, IHC\u002FFISH-defined HER2-positive breast cancer will have a MammaPrint®\u002FBluePrint® assay performed on the diagnostic biopsy specimen, ordered by the treating Oncologist as standard care",[26,223],{"date":35,"type":36},{"date":390,"type":36},"2024-12-05",{"date":392,"type":22},"2028-06",{"name":394,"class":43},"University of Illinois at Chicago",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":84,"phases":404,"briefSummary":405,"conditions":406,"keywords":413,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":431},"100529338","a-study-of-her3-dxd-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-100529338","NCT06172478","A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors","HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for enrollment into the study:\n\n1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all subjects to meet the baseline tumor tissue requirement.\n2. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n3. Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows:\n\n   Cutaneous (acral and non-acral) melanoma\n   1. Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma\n   2. Disease progression while on or after having received treatment with ≥1 prior line of anti-programmed cell death protein (PD-1) or anti-programmed death-ligand 1 (PD-L1) based therapy (previous use of other immune checkpoint inhibitors \\[ICIs\\] \\[ie, anti-CTLA4, anti- LAG-3\\] is acceptable). Prior anti-PD-(L)1 therapy in the adjuvant setting is allowed if there is recurrence within 12 weeks of the last dose. If the participant had BRAFm melanoma, they must have had disease progression on BRAF\u002FMEK inhibitor therapy as well.\n\n      Squamous cell carcinomas of the head and neck\n   3. Squamous cell carcinoma of the head and neck (with a primary location of oral cavity,oropharynx, larynx, hypopharynx) that is human papillomavirus (HPV) positive or negative (as determined by local standard). Excludes tumor location in the nasopharynx, nasal cavity, paranasal sinuses, and unknown primary locations.\n   4. Disease progression after having received treatment with ≥1 and \\\u003C3 prior lines of systemic therapy in the unresectable recurrent or metastatic setting.\n\n      Must have had disease progression on anti-PD-(L)1 (either as monotherapy or in combination with chemotherapy or other therapies). Must also have had disease progression on a platinum-based chemotherapy (PBC) regimen either in the recurrent or metastatic setting or in the locally advanced setting with curative intent.\n\n      Gastric or GEJ adenocarcinoma\n   5. Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry \\[IHC\\] 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   6. Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.\n\n      Ovarian Carcinoma\n   7. Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n   8. Documented disease progression ≥4 weeks after the last dose of PBC and \\\u003C6 months of last dose of PBC in the advanced or metastatic setting. Prior use of folate reductase alpha targeting antibody-drug conjugate (ADC) (ie, mirvetuximab soravtansine) is allowed.\n\n      Cervical Cancer\n   9. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.\n   10. Disease progression after having received ≥1 line of systemic therapy in the recurrent or metastatic setting. This may include prior anti-PD-(L)1 treatment and\u002For tissue factor directed ADC (tisotumab vedotin \\[TV\\]) per regional standard of care.\n\n       Endometrial Cancer\n   11. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological sub-type or endometrial carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair (MMR) status.\n   12. Documented disease progression after having received ≥1 prior line of therapy (maximum of 3) PBC containing systemic treatment and an anti-PD(L)-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Bladder Cancer\n   13. Pathologically or cytologically documented locally advanced\u002Funresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant. Small cell\u002Fneuroendocrine tumors are not allowed even if mixed histology.\n   14. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. At least 1 line of therapy must also contain one of the following treatment modalities: chemotherapy or enfortumab vedotin. Prior fibroblast growth factor receptor (FGFR)-inhibitor treatment for those who are eligible are allowed.\n\n       * Required treatments can be given in combination or sequentially\n       * Prior cisplatin-based therapy or PD-(L)1 inhibitor therapy given for the treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy\n       * The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy\n       * Participants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination can be enrolled.\n\n       Esophageal Carcinoma\n   15. Pathologically or cytologically documented esophageal squamous cell carcinoma.\n   16. Must have documented disease progression after having received 2 prior lines of therapy including previous PBC with or without an anti-PD-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Pancreatic Carcinoma\n   17. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.\n   18. Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced\u002Fmetastatic setting.\n\n       Prostate Cancer\n   19. Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).\n   20. Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.\n   21. Surgically or medically castrated, with testosterone levels of \\\u003C50 ng\u002FdL.\n   22. Documented objective progression as determined by radiographic progression for subjects with measurable disease after androgen deprivation.\n   23. Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.\n   24. Relapsed or disease progression after having received ≥1 cytotoxic chemotherapy regimen that included a taxane.\n\n       Gastric Cancer 2L\n   25. Must have had gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   26. Disease progression after having received treatment with only 1 prior line of systemic anti-cancer therapy that includes 5-FU-based chemotherapy with or without an anti-PD-1 therapy. For subjects whose tumors are claudin (CLDN) 18.2 positive, treatment with 5-FU based chemotherapy with CLDN18.2 directed therapy in the first-line setting is allowed.\n\n   Non-small Cell Lung Cancer aa. Histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation bb. Documentation of absence of actionable driver mutation (ie, ALK rearrangement, BRAF V600E mutation, EGFR-activating mutations \\[exon 19 deletion or L858R mutation\\], EGFR exon 20 insertion mutation, HER2 mutation, KRAS G12C mutation, MET exon 14 skipping mutation, NTRK 1\u002F2\u002F3 gene fusion, RET rearrangement, or ROS1 rearrangement). New testing for these genomic alterations is not required for Screening.\n\n   cc. Relapsed or disease progression after receiving only anti-PD-(L)1 and PBC (ie, platinum doublet) administered in combination or sequentially for metastatic disease.\n\n   Breast Cancer dd. Pathologically documented breast cancer that is assessed as HER2 negative (IHC2+\u002FISH-, IHC1+, or IHC0 per ASCO\u002FCAP guidelines), and HR positive (either ER and\u002For PgR positive \\[ER or PgR ≥1%\\] per ASCO\u002FCAP guidelines). The HER2 and HR results must be from a tumor sample obtained in the metastatic setting.\n\n   ee. Participant must have received one line of chemotherapy for mBC, but not more than one line and must have a clinically or radiologically documented evidence of tumor progression on or after CDK 4\u002F6 inhibitor combined with endocrine therapy; previous treatments with phosphoinositide 3-kinase (PI3K) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, protein kinase B (PKB) inhibitors also known as AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed.\n4. Has ≥1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment. Prostate cancer participants with bone only disease may be eligible.\n5. Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:\n\n   1. Tumor biopsy from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the tissue ICF (ARCHIVAL PRETREATMENT sample).\n\n      OR\n   2. Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)\n6. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n2. Has nasopharyngeal cancer.\n3. Has mucosal or uveal melanoma.\n4. Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n5. Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses\n6. Is receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1.\n\n   Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.\n7. Had prior treatment with an anti-HER3 antibody and\u002For antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan).\n8. Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:\n\n   1. Adequately treated nonmelanoma skin cancer\n   2. Adequately treated intraepithelial carcinoma of the cervix\n   3. Any other curatively treated in situ disease\n9. Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness\u002Fsocial situations, geographical factors, substance abuse, or other factors that, in the investigator's opinion, make it high risk for the subject to participate in the study or that would jeopardize compliance with the protocol\n10. Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.",{"count":403,"type":22},740,[220],"This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \\[cutaneous\u002Facral\\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.",[407,192,197,408,409,249,252,250,410,411,253,412,191,26],"Advanced Solid Tumor","Gastric Cancer","Ovarian Carcinoma","Esophageal Cancer","Pancreatic Carcinoma","Non-small Cell Lung Cancer (NSCLC)",[407,192,197,408,414,415,416,417,418,419,420,421,422,423,191,26],"Ovarian carcinoma","Cervical cancer","Endometrial cancer","Bladder cancer","Esophageal carcinoma","Pancreatic carcinoma","Prostate cancer","Patritumab Deruxtecan","HER3-DXd","U3-1402",{"date":35,"type":36},{"date":426,"type":36},"2024-02-26",{"date":428,"type":22},"2028-10-10",{"name":430,"class":296},"Daiichi Sankyo",86,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":84,"phases":441,"briefSummary":443,"conditions":444,"keywords":445,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":470},"100524065","phase-3-a-phase-iii-study-of-dato-dxd-with-or-without-durvalumab-compared-with-investigators-choice-of-chemotherapy-in-combination-with-pembrolizumab-in-patients-with-pd-l1-positive-locally-recurrent-inoperable-or-metastatic-triple-negative-breast-cancer-tropion-breast05-100524065","NCT06103864","A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)","A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)","Key Inclusion Criteria\n\n* Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines.\n* ECOG PS 0 or 1.\n* Participants are expected to provide an FFPE tumour sample collected from a locally recurrent inoperable or metastatic tumour. Alternatively, an archival FFPE tumour sample can be submitted; it must have been collected ≤ 3 years prior to the participant signing informed consent (screening start).\n* PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated central laboratory.\n* No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.\n\n  \\- Patients with recurrent disease will be eligible if they have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months have elapsed between completion of treatment with curative intent and the first documented recurrence.\n* Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin).\n* Measurable disease as per RECIST 1.1.\n* Adequate bone marrow reserve and organ function.\n* Male and female participants of childbearing potential must agree to use protocol-specified method(s) of contraception.\n\nKey Exclusion Criteria\n\n* As judged by investigator, any evidence of diseases (such as severe or uncontrolled medical conditions including systemic diseases, uncontrolled hypertension, serious gastrointestinal conditions associated with diarrhoea, chronic diverticulitis or previous complicated diverticulitis, history of allogeneic organ transplant, and active bleeding diseases, ongoing and active infection, significant cardiac conditions, substance abuse, psychiatric illness\u002Fsocial situation or psychological conditions) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.\n* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before Cycle 1 Day 1 and of low potential risk for recurrence.\n* Participants with a history of previously treated neoplastic spinal cord compression or treated, clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy.\n\n  \\- Participants with treated clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy.\n* Uncontrolled infection requiring IV antibiotics, antivirals or antifungals.\n* Active or uncontrolled hepatitis B or C virus infection.\n* Known HIV infection that is not well controlled.\n* Uncontrolled or significant cardiac disease.\n* History of non-infectious ILD\u002Fpneumonitis (including radiation pneumonitis) that required steroids, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* Clinically severe pulmonary function compromise.\n* Clinically significant corneal disease.\n* Active or prior documented autoimmune or inflammatory disorders.\n* Prior exposure to any treatment including ADC containing a chemotherapeutic agent targeting topoisomerase I and TROP2-targeted therapy.\n* Any concurrent anti-cancer treatment.\n* Participants with a known severe hypersensitivity to PD-1\u002FPD-L1 inhibitors or Dato-DXd.\n* Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.",{"count":440,"type":22},625,[442],"PHASE3","This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.",[26],[26,446,447,448,449,450,451,452,453,454,455,456,457,458,459,460,461,462],"Triple-negative","Metastatic","Inoperable","Datopotamab deruxtecan","Dato-DXd","DS1062a","DS1062","Durvalumab","Paclitaxel","Nab-paclitaxel","Gemcitabine","Carboplatin","Pembrolizumab","PD-1\u002FPD-L1 Therapy","TROP2","Antibody Drug Conjugate (ADC)","Immune Checkpoint Inhibitor (ICI)",{"date":33,"type":36},{"date":465,"type":36},"2023-11-23",{"date":467,"type":22},"2030-09-30",{"name":469,"class":296},"AstraZeneca",320,{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":480,"conditions":481,"keywords":482,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":235},"100484661","observational-study-of-bone-complications-in-people-with-post-menopausal-breast-cancer-who-have-stopped-treatment-with-denosumab-and-aromatase-inhibitors-100484661","NCT05590949","Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors","Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound Bone Loss and Insufficiency Fractures After Denosumab Discontinuation","Inclusion Criteria:\n\n* Women with confirmed diagnosis of breast cancer\n* Participant must be post-menopausal, defined as last menstrual cycle at least 12 months prior to enrollment\n* Received at least 2 doses of denosumab and then discontinued therapy\n* Discontinued AI prior to or within 6 months of last denosumab injection\n* Patients must be 18 years of age or olde\n\nExclusion Criteria:\n\n* Patients with history of osteoporosis prior to starting denosumab, based on previous dual-energy X-ray absorptiometry (DEXA) scan;\n* Patients with history of insufficiency fracture.\n* Patients who continue treatment with a different bone modifying agent (i.e oral or intravenous bisphosphonates) after discontinuation of denosumab\n* Patients on chronic low-dose glucosteroids.",{"count":479,"type":22},100,"The purpose of this study to gather information about changes in the bones after stopping treatment with aromatase inhibitor\u002FAI and denosumab. The study team will collect information from 5 standard clinic visits over the course of 24 months. The information will include information about participant health assessments, blood test results, and imaging results. After 24 months, participation in this study will be complete.",[26],[483,26,484,485,486,227],"Post-menopausal Breast Cancer","Denosumab","Aromatase","22-280","2026-08-18",{"date":33,"type":36},{"date":490,"type":36},"2022-10-18",{"date":492,"type":22},"2026-10-18",{"name":227,"class":43},{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":84,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":44},"100265239","penn-surveillance-markers-of-utility-for-recurrence-after-neoadjuvant-therapy-for-breast-cancer-100265239","NCT02732171","PENN-Surveillance Markers of Utility for Recurrence After (Neo)Adjuvant Therapy for Breast Cancer","Inclusion Criteria:\n\n* Histologically-confirmed primary invasive breast cancer within 5 years of study entry\n* Qualifying risk status, at diagnosis utilizing receptor testing by ASCO\u002FCAP guidelines, meeting at least one of the following:\n\n  * Pathologically-confirmed invasive breast cancer in axillary lymph nodes, regardless of receptors\n  * Primary tumor with triple negative subtype: estrogen receptor (ER) \\\u003C 10%, progesterone receptor (PR) \\\u003C 10% and negative Her2-overexpression by ASCO-CAP guidelines\n  * Primary tumor that is ER+\u002FHer2 negative\u002FLymph node negative with a Breast Cancer Recurrence Score of ≥ 25 per the Genomic Health Oncotype DX breast cancer test and\u002For HighRisk MammaPrint\n  * Evidence of residual disease in the breast on pathologic assessment after neoadjuvant chemotherapy\n* Completed all primary therapy (surgery, (neo)adjuvant chemotherapy, adjuvant radiation, and\u002For Her2-directed therapy) for the index malignancy at least 4 weeks prior to study entry. Concurrent receipt of adjuvant endocrine therapy and bone modifying agents is allowed per standard of care. However, tamoxifen is not allowed on recurrence prevention trials that use Hydroxychloroquine. Patients on tamoxifen may still be enrolled on Penn-Surmount as long as the treating physician is aware and tamoxifen can be stopped if patient is DTC positive.\n* No evidence of local or distant recurrent disease by physical examination, blood tests (CBC, LFTs, Alk Phos), or symptom-directed imaging, per NCCN guidelines.\n* Adequate bone marrow function as shown by: ANC \\>\u002F= 1.5x10\\^9\u002FL, Platelets \\>\u002F= 100x10\\^9\u002FL, Hb \\> 9 g\u002FdL\n* Adequate liver function as shown by: Serum bilirubin \\\u003C\u002F= 1.5 x ULN, ALT and AST \\\u003C\u002F= 2.5 x ULN, and INR \\\u003C\u002F= 1.5\n* Normal coagulation studies: PT and PTT ≤ 1.5 x upper limit of normal per institutional laboratory range\n* Anti-coagulation is allowed if target INR \\\u003C\u002F= 1.5 on a stable dose of warfarin or on a stable dose of anticoagulant for \\>2 weeks at time of enrollment. For patients on therapeutic anti-coagulants, medication must be clinically held peri-procedure (bone marrow aspirate) per standard clinical management.\n* Adequate renal function: serum creatinine \\\u003C\u002F= 1.5 x ULN\n* Willing to undergo bone marrow aspiration and blood specimen collection per protocol specifications\n* Age 18 or over and able to give informed consent\n\nExclusion Criteria:\n\n* Concurrent enrollment on another investigational therapy\n* Patients receiving chronic, high dose systemic treatment with corticosteroids defined as: chronic use of cortisone \\>50mg; hydrocortisone \\>40mg, prednisone \\>10mg, methylprednisone \\>8mg or dexamethasone \\>1.5mg; or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.\n* EKG demonstrating QTC \\> 480 ms\n* Patients who have any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\n\n  * History or evidence of increased cardiovascular risk including any of the following: (i) current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation, (ii) History of acute coronary syndromes (including myocardial infarction and unstable angina, coronary angioplasty, or stenting within 6 months prior to enrollment, (iii) Current \\>\u002F= Class II congestive heart failure as defined by New York Heart Association\n  * History of pneumonitis\u002Finterstitial lung disease or severely impaired lung function with a previously documented spirometry and DLCO that is 50% of the normal predicted value and\u002For 02 saturation that is 88% or less at rest on room air\n  * Uncontrolled diabetes\n  * Active (acute or chronic) or uncontrolled severe infections\n  * Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis\n  * A known history of HIV seropositivity as reported by the patient\n  * History of major surgical resection involving the stomach or small bowel, or pre-existing impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, Crohn's disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)\n  * Patients with an active, bleeding diathesis\n  * History of retinopathy or retinal vein occlusion\n* Female patients who are pregnant or breast feeding. Women of childbearing potential must have a negative urine or serum pregnancy test.\n* Patients who have received prior treatment with a CDK4\u002F6 inhibitor\n* Patients with a known hypersensitivity to Hydroxychloroquine or any of its derivatives\n* Patients with prior hydroxychloroquine exposure for a duration of \\> 1 month since the completion of the patient's primary therapy (definitive surgery, (neo)adjuvant chemotherapy, adjuvant radiation, and\u002For Her2-directed therapy) for the index malignancy\n* Patients who have initiated bone modifying agents within 3 months prior to study enrollment\n* A detailed assessment of Hepatitis B\u002FC medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and\u002For confirmation of prior HBV\u002FHCV infection.",{"count":501,"type":22},600,[86],"This is a single center, prospective cross-sectional study of women who have completed therapy for primary breast cancer within 5 years of diagnosis and are at increased risk for relapse.\n\nPatients will undergo screening bone marrow aspirate to test for presence of disseminated tumor cells (DTCs) Patients who harbor DTCs will be offered the opportunity for enrollment into a clinical trial of therapy targeting DTCs to prevent recurrence (separate protocols).",[26],{"date":125,"type":36},{"date":507,"type":4},"2016-04",{"date":509,"type":22},"2030-04",{"name":511,"class":43},"Abramson Cancer Center at Penn Medicine",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":84,"phases":520,"briefSummary":521,"conditions":522,"keywords":524,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":530,"leadSponsor":532,"locationsCount":235},"100652693","phase-2-a-study-of-romosozumab-in-people-with-breast-cancer-and-osteoporosis-100652693","NCT07776613","A Study of Romosozumab in People With Breast Cancer and Osteoporosis","A Phase II Study Evaluating the Efficacy and Safety of Romosozumab as a Bone-Modifying Agent in Patients With Metastatic Breast Cancer to Bones and Osteoporosis With High Fracture Risk (REMOLD-Breast)","Inclusion Criteria:\n\n* ≥18 years of age at the time of giving informed consent;\n* Patients diagnosed with hormone-receptor positive (ER\u002FPR \\>1%) metastatic breast cancer to bones on any endocrine therapy with or without targeted therapy (i.e. CDK 4\u002F6 inhibitors, PI3K inhibitors, anti-HER2-therapy);\n* Evidence of osteoporosis on dual X-ray absorptiometry (DXA) scan; must following:\n* osteoporosis on dual X-ray absorptiometry (DXA) scan; or history of fragility fracture of the spine or hip; or of morphometric spine fracture;\n\nExclusion Criteria:\n\n* Prior therapy with a bone-modifying agent (intraveous bisphosphonates or subcutaneous denosumab) for metastatic bone disease;\n* 25 (OH) vitamin D levels \\\u003C 20 ng\u002FmL; Vitamin D repletion will be permitted and subjects will be be rescreened once 25 (OH) vitamin D level ³ 20 ng\u002FmL;\n* History of myocardial infarction or stroke within the preceding year;\n* Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range per institutional standard (\\\u003C8.5 or \\>10.5 mg\u002FdL); Calcium repletion will be permitted and subjects will be be rescreened once values are within the institutional standard.\n* History of non-healed dental or oral surgery;\n* History of osteonecrosis of the jaw",{"count":7,"type":22},[220],"The researchers are doing this study to see if romosozumab is effective at helping with bone formation in people with metastatic breast cancer (MBC) that has spread to the bones. All participants will have osteoporosis. The researchers will also look at bone breakdown (resorption) in participants and determine if romosozumab is a safe treatment for osteoporosis in people with MBC that has spread to the bones.",[26,523],"Metastatic Breast Cancer (MBC)",[525,526],"Romosozumab","26-191","2026-08-17",{"date":33,"type":36},{"date":527,"type":36},{"date":531,"type":22},"2028-08",{"name":227,"class":43},{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":84,"phases":541,"briefSummary":542,"conditions":543,"keywords":549,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":555,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":44},"100652655","monitoring-for-cardiotoxicity-using-wearable-devices-while-undergoing-cancer-treatments-mct-wave-100652655","NCT07776964","Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)","Inclusion Criteria:\n\n* Diagnosis of breast cancer, hematologic malignancy including leukemia or lymphoma, or multiple myeloma\n* At least 18 years of age\n* Capable of understanding and willing to sign a consent form for this study\n\nExclusion Criteria:\n\n* Known allergy to adhesive patches used for ambulatory EKG monitoring\n* Children\n* Cognitively challenged individuals\n* Prisoners\n* Active service military personnel",{"count":540,"type":22},72,[86],"This pilot study will evaluate the validity and feasibility of ambulatory cardiac monitoring to identify markers of cardiotoxicity in adults undergoing cancer treatment.\n\nParticipants with breast cancer, hematologic malignancy, or multiple myeloma will receive usual care plus two wearable patch monitors: mobile cardiac telemetry using the BodyGuardian Mini Plus ambulatory ECG monitor and an investigational wearable cardiac monitor that records heart sounds. The study will assess arrhythmias detected by mobile cardiac telemetry and explore whether heart sounds are associated with echocardiographic findings and cardiac biomarkers.\n\nParticipants will wear the devices during cancer treatment, with monitoring periods at baseline and possible repeat monitoring at 6-month and 12-month study visits.",[544,545,546,547,26,548],"Cardiotoxicity","Cancer","Cardiac Arrhythmia","Left Ventricular Dysfunction","Multiple Myeloma",[550,551,552,553,554,30],"MCT-WAVE","Mobile cardiac telemetry","Wearable cardiac monitor","Cardio-oncology","Ventricular arrhythmia",{"date":33,"type":36},{"date":557,"type":22},"2026-09-01",{"date":559,"type":22},"2028-09-01",{"name":561,"class":43},"University of Minnesota",{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":84,"phases":572,"briefSummary":573,"conditions":574,"keywords":575,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":585,"locationsCount":133},"100652561","physical-activity-and-healthy-aging-promoting-cardio-metabolic-capacity-to-fight-chronic-inflammation-and-improve-outcomes-in-breast-cancer-patients-phacthealth-study-100652561","NCT07776951","Physical Activity and Healthy Aging: Promoting Cardio-metabolic Capacity to Fight Chronic Inflammation and Improve Outcomes in Breast Cancer Patients (PhActHealth Study)","PhActHealth - Physical Activity and Healthy Aging: Fighting Low Grade Chronic Inflammation to Put Out the Cardio-oncologic Risk","PhActHealth","Inclusion Criteria:\n\n* being a patient with first diagnosis of primary BC;\n* luminal BC tumor subtype B defined as positive for estrogen and\u002For progesterone receptor expression, HER2 negative and high Ki-67; or triple Negative BC tumor subtype defined as negative for estrogen and\u002For progesterone receptor expression, HER2 negative, defined by the Pathology and Medical Oncology units as defined by the ESMO Guidelines Committee (referred to the American Society of Clinical Oncology\u002FCollege of American Pathologists guidelines for assessment of hormone receptor (HR) status (i.e. ER and 4 PgR)25 and HER2 status, and by the International Ki-67 in Breast Cancer Working Group for Ki-67);\n* candidate for chemotherapy\u002Fimmunotherapy neoadjuvant treatment;\n* signed informed consent for study participation;\n* declared being not engaged in any competitive or recreational physical activity.\n\nExclusion Criteria:\n\n* therapeutic modifications during the intervention period;\n* presence of chronic conditions (such as autoimmune diseases, neurodegenerative diseases, psychiatric disorders\u002Fcognitive disabilities, chronic obstructive pulmonary disease);\n* presence of any condition that significantly impairs the ability to perform exercise;\n* pregnancy\u002Flactation\u002Fintention to initiate pregnancy;\n* prior chemotherapy or immunotherapy within the past three years;\n* high baseline physical activity level (i.e. performing exercise at a dose of 600 MET minutes a week or greater, according to the score of the International Physical Activity Questionnaire \\[IPAQ\\]).",{"count":571,"type":22},126,[86],"PhActHealth is a multicenter randomized controlled trial enrolling women with newly diagnosed luminal B or triple-negative breast cancer (BC) who are candidates for neoadjuvant therapy. The study aims to investigate the effects of a preoperative, unsupervised exercise training program on exercise capacity, as well as on immune response, autonomic nervous system (ANS) regulation, cardiovascular health, and tumor aggressiveness prior to surgical removal.\n\nParticipants are randomly assigned to either an intervention group or a control group. All patients receive lifestyle counseling, while those in the intervention group additionally follow a personalized aerobic and resistance exercise program throughout the neoadjuvant treatment period before surgery.\n\nThe primary outcome is the improvement in exercise capacity. The secondary outcomes are tumor-specific and systemic responses to the intervention, evaluated by analyzing molecular, metabolic, and inflammatory markers, as well as clinical and functional parameters.",[26],[576,577,62,578,579,580],"chronic inflammation","luminal B breast cancer","lifestyle intervention","exercise","METs",{"date":33,"type":36},{"date":583,"type":36},"2026-02-01",{"date":293,"type":22},{"name":586,"class":43},"University of Milan",{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":594,"enrollmentInfo":595,"targetDuration":4,"studyType":84,"phases":597,"briefSummary":598,"conditions":599,"keywords":600,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":603,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":4},"100652510","phase-1-study-of-skb103-in-her2-negative-breast-cancer-100652510","NCT07774624","Study of SKB103 in HER2-negative Breast Cancer","A Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB103 in Participants With Locally Advanced, Recurrent, or Metastatic HER2-negative Breast Cancer.","Key Inclusion Criteria:\n\n1. Willingness to participate in the study, sign the informed consent form(ICF), and comply with the protocol-specified visits and relevant procedures.\n2. Aged ≥ 18 and ≤ 75 years at the time of signing ICF.\n3. Histologically and\u002For cytologically confirmed HER2-negative Breast cancer who have failed standard therapy.\n4. Participants should provide tumor tissue samples for biomarker testing as much as possible.\n5. At least one measurable lesion per RECIST v1.1.\n6. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1.\n7. Life expectancy ≥ 12 weeks.\n8. Acceptable bone marrow and organ function.\n9. Male and female participants must agree to use highly effective contraceptive methods during the study period.\n\nKey Exclusion Criteria:\n\n1. Participants with known meningeal metastases, brainstem metastases, spinal cord metastases and\u002For compression, and active central nervous system (CNS) metastases.\n2. Participants with other malignant tumors within 3 years prior to the first administration.\n3. Presence of any serious cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n4. Presence of any uncontrolled systemic disease, as judged by the investigator.\n5. Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.\n6. History of interstitial lung disease or noninfectious pneumonitis.\n7. Other lung diseases that may interfere with drug-related pulmonary toxicity or may cause clinically serious lung injuries.\n8. Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of corneal disorders that prevent\u002Fdelay corneal healing.\n9. Presence of risk of developing esophagotracheal fistula or esophageal pleural fistula, or tumor invasion or compression of surrounding vital organs and major blood vessels with related clinical symptoms.\n10. Clinical symptoms of intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess within 3 months prior to the first administration.\n11. Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.\n12. Has experienced immune-related adverse events (irAE) of Grade 3 or higher during prior immunotherapy\n13. Serious infection occurred within 4 weeks prior to the first administration.\n14. Active hepatitis B or hepatitis C.\n15. Positive result of human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.\n16. Known active pulmonary tuberculosis.\n17. Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n18. History of allergies to any component of SKB103 injection, or severe hypersensitivity reaction to other monoclonal antibodies.\n19. Has received prior antibody or drug therapy targeting T-cell co-stimulatory or checkpoint pathways, or cell therapy.\n20. Received chemotherapy, immunotherapy, biological therapy, or other large molecule anti-tumor drugs within 4 weeks prior to the first administration.\n21. Has received radiation therapy to lung lesions with a total dose \\>30 Gy within 6 months prior to the first dose of study drug.\n22. Participants who received major surgeries 4 weeks prior to the first administration.\n23. Participants who received other investigational drugs within 4 weeks prior to their first administration.\n24. Participants who have previously received anti-tumor vaccines or have received any live vaccines within 4 weeks prior to the first administration or scheduled to receive live vaccines during study treatment.\n25. Receipt of systemic corticosteroid therapy (\\>10mg of prednisone or its equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose.\n26. Receipt of strong inhibitors or inducer of cytochrome P450（CYP3A4） or inhibitors of breast cancer resistance protein (BCRP) within 2 weeks prior to the first administration or within 5 half-lives of the known drugs(whichever is longer).\n27. Pregnant or lactating women.\n28. Known history of psychiatric disorder or substance abuse that may interfere with study compliance.\n29. Has any local or systemic condition (non malignant or tumor related) that may impair protocol compliance.\n30. Any condition that, in the opinion of the Investigator, may interfere with the evaluation of the study drug, participant safety, or interpretation of the study results; or any other condition that the investigator deems unsuitable for participation in this study.","75 Years",{"count":596,"type":22},140,[277,220],"This is a Phase I\u002FII clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced (locally advanced, recurrent, or metastatic) HER2-negative breast cancer. The study includes a Phase 1 dose escalation stage and a Phase 2 indication expansion stage.",[26],[601,26,602],"HER2-negative Breast Cancer","SKB103",{"date":125,"type":36},{"date":605,"type":22},"2026-08-31",{"date":607,"type":22},"2030-12-31",{"name":609,"class":296},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.",{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":84,"phases":618,"briefSummary":619,"conditions":620,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":44},"100635492","phase-1-phase-1b-study-of-trick-nk-in-combination-with-t-dxd-in-treatment-refractory-breast-cancers-100635492","NCT07553390","Phase 1b Study Of TRICK-NK In Combination With T-Dxd In Treatment-Refractory Breast Cancers","Phase 1b Study Of Allogeneic CAR TROP2\u002FIL15 Transduced TGFBR2 KO CB NK-Cells (TRICK-NK) In Combination With Trastuzumab Deruxtecan (T-Dxd) In Treatment-Refractory Breast Cancers","Inclusion Criteria:\n\n1. Patients must have histologically confirmed breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.\n2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.\n3. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of TRICK-NK cells in patients \\\u003C18 years of age, children are excluded from this study.\n4. For patients with triple negative subtype (TNBC, ER\\\u003C1%, PR 1%, HER2 negative per ASCO\u002F CAP 2018 guideline), must have received at least one dose of Sacituzumab govitecan or anti-TROP2 antibody drug conjugate (ADC)\n5. Patients must be at least 2 weeks from last cytotoxic chemotherapy, tyrosine kinase inhibitors or other targeted therapies at the time of administration of lymphodepleting chemotherapy.\n6. Patients must be at least 3 months from any cell therapy for malignancy (this is not a criteria for repeated treatments).\n7. Localized radiotherapy to 1 or more disease sites is allowed prior to the lymphodepleting chemotherapy, if there are additional measurable non-irradiated disease sites.\n8. Eastern Cooperative Oncology Group performance status 0 or 1 (Performance level as measured by Karnofsky for patients \\> 16 years of age, see Appendix A).\n9. Adequate organ function at screening, as defined by the following:\n10. Renal: Estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration equation) ≥50 ml\u002Fmin\u002F1.73 m2\n11. Hepatic: alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if documented liver metastases, total bilirubin ≤ 1.5 mg\u002FdL or ≤ 3.0 mg\u002FdL for patients with Gilbert's Syndrome. No history of liver cirrhosis.\n\n    Cardiac: Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan, and no symptomatic cardiac disease or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication) Pulmonary: No clinically significant pleural effusion (per principal investigator \\[PI\\] judgement), and baseline oxygen saturation ≥ 92% on room air. Subjects with active interstitial lung disease (ILD)\u002Fpneumonitis requiring treatment with systemic steroids will be excluded.\n\n    Hematological: absolute neutrophil count (ANC) ≥ 1000\u002Fmm3, platelet count ≥ 75,000\u002Fmm3, and hemoglobin ≥ 8 g\u002FdL. Coagulation: International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 ULN. Patients on therapeutic doses of anticoagulation medication must have INR and\u002For aPTT ≤ the upper limit of the therapeutic range for intended use.\n12. Able to provide written informed consent.\n13. Weight ≥40 kg (due to safety of NK-cell).\n14. A female patient is eligible to participate if at least one of the following conditions applies:\n\n    a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 OR\n15. A WOCBP who agrees to follow the contraceptive guidelines in Appendix 5 during the study treatment period and for 6 months post-TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion.\n\n    WOCBP must have a negative urine pregnancy test within 72 hours prior to the start of lymphodepleting chemotherapy. If a WOCBP has a urine pregnancy test that cannot be confirmed as negative, a serum (beta-human chorionic gonadotropin \\[β-hCG\\]) pregnancy test will be required.\n\n    The effects of TROP2 CAR\u002FIL-15 TGFBR2 KO NK cells on the developing human fetus are unknown. Radiation therapy is absolutely contraindicated in pregnant women. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n16. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n17. Male patients treated or enrolled on this protocol must agree to follow the contraceptive guidelines in Appendix 5 prior to study entry and for the duration of study participation and for 6 months post-TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion. Male patients who father a child or suspect that they have fathered a child must immediately notify their doctor.\n18. Willing to undergo mandatory blood collections and biopsies as required by the study.\n19. Willing to sign consent for long-term follow-up on protocol PA17-0483.\n20. Willing to stay within a 2-hour drive (approximately 100-mile radius) of the study site during the first 4 weeks after the TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from study entry:\n\n1. Presence of clinically significant ongoing Grade ≥ 2 toxicity unequivocally associated with the previous anticancer treatment, as determined by the PI. Toxicities related to prior surgery, radiation, prior systemic immune checkpoint inhibitors and chemotherapy should be resolved to Grade 1 or below prior to lymphodepletion.\n2. Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management or not responding to appropriate therapy. Note: Patients with simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.\n3. Known active hepatitis B or C.\n4. Known human immunodeficiency virus (HIV).\n5. Presence of active neurological disorder(s).\n6. Active autoimmune disease within 12 months of enrollment (excluding low-grade psoriasis or well-controlled autoimmune thyroid disease).\n7. Amyloidosis or POEMS syndrome.\n8. Symptomatic or uncontrolled central nervous system involvement or signs of cord compression. In the case radiation therapy is indicated, the washout must be at least 14 days.\n9. Patients must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, adequately treated (without recurrence post resection or post radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, or active non-life-threatening second malignancy that would not, in the investigator's opinion, potentially interfere with the patient's ability to participate and\u002For complete this trial. Examples include but are not limited to urothelial cancer Grade Ta or T1 and adenocarcinoma of the prostate treated by active surveillance.\n10. Presence of any other serious medical condition that may endanger the patient at investigator's discretion, including but not limited to:\n11. New York Heart Association Class III or IV heart failure\n12. Myocardial infarction or stroke ≤ 26 weeks prior to CAR NK cell infusion\n13. Unstable angina within ≤ 13 weeks prior to CAR NK cell infusion unless the underlying disease has been corrected by procedural intervention (e.g., stent, bypass)\n14. Severe aortic stenosis\n15. Uncontrolled arrhythmia. PI approval is required for patients with arrhythmia who may be included as an exception.\n16. Congenital long QT syndrome. PI approval is required.\n17. Documentation, during the screening process, of a QTc \\> 470 milliseconds by Fredericia criteria (QTcF) based on the average of 3 electrocardiograms (ECGs) taken approximately 1 minute apart and all within 10 minutes of each other. The patient should be reclining for 5 minutes prior to ECGs. Local readings may be used for this exclusion criterion.\n18. Major surgery \\\u003C 4 weeks prior to first dose of lymphodepleting chemotherapy.\n19. Concomitant use of other investigational agents.\n20. Concomitant use of other anticancer agents.\n21. Patients receiving systemic steroid therapy at time of enrollment, with an exception for topical, ocular, intranasal, and inhaled corticosteroids, or systemic corticosteroids at an equivalent dose ≤ 10 mg of prednisone daily (physiological substitutive doses are allowed).\n22. Received anti-thymocyte globulin within 14 days or alemtuzumab within 28 days of enrollment.\n23. Patients receiving immunosuppressive therapy.\n24. Pregnant or breastfeeding.\n25. Has received a live vaccine within 6 weeks prior to CAR NK cell infusion. Examples of live vaccines include but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza and COVID-19 vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.",{"count":218,"type":22},[277],"The goal of this clinical research study is to find the highest tolerable dose of TGFBR-2 KO CD70 CAR NK (TRICK-NK) in combination with 2 doses of T-Dxd that can be given to participants who have advanced breast cancer. The safety of TRICK-NK will also be studied.\n\nThe goal of Part 1 (dose escalation) of this clinical research study is to find the highest tolerable dose of TRICK-NK (in combination with T-Dxd) that can be given to participants who have advanced breast cancer.\n\nThe goal of Part 2 (dose expansion) of this clinical research study is to learn if the dose of TRICK-NK found in Part 1 can help to control the disease.\n\nThe optional schedule optimization phase will test a shorter interval between the NK cell infusion and the first dose of T-Dxd.",[26],{"date":125,"type":36},{"date":623,"type":22},"2026-10-01",{"date":625,"type":22},"2038-03-30",{"name":627,"class":43},"M.D. Anderson Cancer Center",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":18,"minAge":635,"maxAge":636,"enrollmentInfo":637,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":638,"conditions":639,"keywords":640,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":648,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":44},"100576773","a-novel-approach-utilizing-organ-specific-age-proteomics-100576773","NCT06789653","A Novel Approach Utilizing Organ Specific Age Proteomics","Investigating Cellular Senescence and Organ Aging in Breast Cancer Patients Undergoing Adjuvant Chemotherapy: A Novel Approach Utilizing Organ Specific Age Proteomics","Inclusion Criteria:\n\n* Age ≥22years and \\\u003C66 years\n* Diagnosed with early-stage breast cancer (The American Joint Committee on Cancer stages I-III).\n* Understand and read English.\n* Receive care at the study site.\n* Able to understand and participate in study procedures for length of study.\n\nExclusion Criteria:\n\n* Unable to provide consent, unable to communicate verbally.\n* Unable to understand or read English.\n* Enrolled in hospice care.","22 Years","66 Years",{"count":21,"type":22},"This study compares changes in P16INK4A expression and plasma proteomic signatures of specific organ age pre- and post-chemotherapy in women treated with adjuvant chemotherapy for early-stage breast cancer. It aims to determine if biological and accelerated immune aging, assessed using T cells from peripheral blood, represents aging in different organs.\n\nPatients receiving chemotherapy, especially adjuvant regimens that include anthracyclines and taxanes, often experience late development of cardiac toxicity, functional loss, and cognitive decline. Comparing baseline characteristics with organ aging before therapy might identify patients at the highest risk for chemotherapy complications. For example, this is clinically significant for patients whose therapy includes taxanes or other drugs known to cause peripheral neuropathy. Identifying aging in the neurological or vascular systems before treatment might lead to changes in regimens.\n\nDetermining accelerated aging in specific organs allows for investigating interventions to mitigate organ damage. For instance, identifying patients at the highest risk of cardiac aging after treatment could lead to testing the effects of exercise, senolytics, and other strategies to reduce the risk of long-term heart disease.",[26],[641,642,643,644,645,646,647],"proteomic","plasma proteomic","P16INK4A","chemotherapy","T cells","aging","morbidity",{"date":487,"type":36},{"date":650,"type":36},"2024-10-10",{"date":652,"type":22},"2027-11-01",{"name":654,"class":43},"UNC Lineberger Comprehensive Cancer Center",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":84,"phases":664,"briefSummary":665,"conditions":666,"keywords":667,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":672,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":679},"100563601","phase-1-a-study-to-evaluate-the-safety-tolerability-drug-levels-and-preliminary-efficacy-of-bms-986507-combinations-in-adult-participants-with-advanced-solid-tumors-100563601","NCT06618287","A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors","A Phase 1\u002F2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Participants must have at least one measurable lesion per response evaluation criteria in solid tumors.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Participants must have a life expectancy of at least 3 months at the time of the first dose.\n* Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed\n* Group B: Participants must have pathologically confirmed locally advanced or metastatic NSCLC.\n* Group C: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC or ER-low, HER2-negative BC.\n* Group D: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC per ASCO\u002FCAP criteria, based on the most recently analyzed biopsy or another pathology specimen.\n* Group E: Participants must have pathologically confirmed locally advanced or metastatic NSCLC, not amenable to treatment in curative intent.\n\nExclusion Criteria\n\n* Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology.\n* Participants with known mutations in EGFR will be excluded (Group A,B and E).\n* Participants must not have a history of serious recurrent infections.\n* Participants must not have a history of severe heart disease.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":663,"type":22},416,[277,220],"The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.",[191,26],[668,669,670,671],"Non-Small Cell Lung Cancer (NSCLC)","Epidermal Growth Factor Receptor mutated (EGFRmt)","Epidermal Growth Factor Receptor wild-type (EGFRwt)","Triple-negative breast cancer (TNBC)",{"date":487,"type":36},{"date":674,"type":36},"2025-02-04",{"date":676,"type":22},"2031-02-26",{"name":678,"class":296},"Bristol-Myers Squibb",66]