[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-metastatic":34},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,51,90,114,145,171,212,242,262,293,324,345,375,406,431,465,489,504,530,552,615,639,674,704,726],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":37,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053937","screening-for-bcrl-in-targeted-therapy-for-breast-cancer-100053937",false,"NCT05142800","Screening For BCRL In Targeted Therapy For Breast Cancer","Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer","Inclusion Criteria:\n\n* Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF\u002FHCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.\n* Subjects that will be eligible for the study include:\n* Females between 18 and 80 years of age\n* With a history of breast cancer\n* 4 weeks or more post-surgery\n* With or without edema\n* Undergoing treatment with targeted therapy for early or metastatic disease.\n\nExclusion Criteria:\n\n\\- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).","FEMALE","18 Years","80 Years",{"count":21,"type":22},261,"ESTIMATED","OBSERVATIONAL","This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer.\n\nA Perometer and Sozo devise will be used to measure volume changes",[26,27,28,29,30,31,32,33,34,35,36],"Lymphedema","Lymphedema Arm","Lymphedema of Upper Arm","Lymphedema of Upper Limb","Lymphedema of the Hands","Edema","Edema Arm","Breast Cancer Lymphedema","Breast Cancer Metastatic","Breast Cancer Stage","Breast Cancer",[26,27,28,29,30,31,32,33,34,35,36],"RECRUITING","2026-07-09",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2018-12-13",{"date":46,"type":22},"2026-09-30",{"name":48,"class":49},"Massachusetts General Hospital","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":75,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100575356","phase-1-slv-154-treatment-of-metastatic-solid-tumors-100575356","NCT06771219","SLV-154 Treatment of Metastatic Solid Tumors","A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Men or women (as appropriate for cancer type) of age ≥18 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n3. Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records with the primary history comprising one of the following:\n\n   1. SCCHN\n   2. NSCLC\n   3. SCLC\n   4. Breast cancer\n   5. Cervical cancer\n   6. Endometrial cancer\n   7. Ovarian cancer\n   8. Urothelial cancer\n   9. Sarcoma\n   10. Thyroid cancer\n4. Presence of metastatic disease that has progressed during or following previous treatment.\n5. Presence of radiographically measurable disease.\n6. Prior receipt of commercially available therapies that are indicated for the subject's cancer and have demonstrated survival benefit for that indication.\n7. Availability of tumor tissue from a fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival tumor sample from a previous biopsy.\n8. Availability of computed tomography (CT) or magnetic resonance imaging (MRI) of chest, abdomen, and pelvis, and\u002For fluorodeoxyglucose (FDG) positron emission tomography (PET)\u002FCT (if appropriate for tumor type) (with PET from base of the skull to mid-thigh, if performed) within 35 days before study drug administration.\n9. Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study drug administration.\n10. Adequate hematological profile.\n11. Adequate coagulation profile.\n12. Adequate hepatic profile.\n13. Adequate renal function.\n14. Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.\n15. For female subjects of childbearing potential, a negative serum pregnancy test.\n16. For female subjects of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.\n17. For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol-recommended method of contraception from the start of study therapy until ≥6 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy.\n18. Willingness and ability of the subject to comply with scheduled visits, the drug administration plan, protocol-specified laboratory tests, other study procedures (including required tumor biopsy\u002Faspirations and\u002For radiographic studies), and study restrictions.\n19. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\n1. Malignancy involving the central nervous system unless brain metastases have been previously treated with radiotherapy, have been stable for ≥4 weeks, and do not require corticosteroids.\n2. Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.\n3. Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.\n4. Significant cardiovascular event or comorbidity.\n5. Significant screening ECG abnormalities.\n6. Pregnancy or breastfeeding.\n7. Major surgery within 4 weeks before the start of study therapy.\n8. Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.\n9. Use of a drug known to prolong the QT interval within 7 days prior to the start of study drug administration.\n10. Concurrent participation in another therapeutic or imaging clinical trial.\n11. Other conditions likely to interfere with a subject's ability to participate in the study.","ALL",{"count":60,"type":22},70,"INTERVENTIONAL",[63],"PHASE1","This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with metastatic solid tumors.",[66,67,68,69,34,70,71,72,73,74],"Squamous Cell Cancer of Head and Neck (SCCHN)","NSCLC","SCLC","Cervical Cancer Metastatic","Endometrial Cancer","Ovarian Cancer","Urothelial Cancer","Sarcoma","Thyroid Cancer",[76,77,78],"metastatic solid tumors","metastatic cancer","solid tumor","2026-06-29",{"date":81,"type":42},"2026-06-30",{"date":83,"type":42},"2025-05-14",{"date":85,"type":22},"2027-04",{"name":87,"class":88},"Solve Therapeutics","INDUSTRY",10,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":61,"phases":99,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100573761","phase-2-trial-of-trastuzumab-deruxtecan-in-previously-treated-her2-100573761","NCT06750484","Trial of Trastuzumab Deruxtecan in Previously Treated HER2","Open-label Single-arm Phase 2 Trial of Trastuzumab Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced Breast Cancer","Inclusion Criteria:\n\n1. Must be competent and able to comprehend, sign, and date an Institutional Review Board (IRB) approved ICF before performance of any study-specific procedures or tests.\n2. Men or women ≥18 years old.\n3. Pathologically documented breast cancer that is unresectable or metastatic.\n4. 4.Tumor biopsies have always shown HER2-IHC 0 (\\\u003C10% membrane staining, including 0 null and 0 ultralow) in all prior biopsies and never previously HER2-positive (IHC 3+ or ISH+) or HER2-low (1+, or 2+ ISH-) on prior pathology testing according to American Society of Clinical Oncology College of American Pathologists (ASCO-CAP) guidelines.\n5. Either HR-positive or HR-negative status of the tumor per ASCO-CAP guidelines are allowed.\n6. Patients with HR-positive disease must have progressed or be intolerant to CDK 4\u002F6 inhibitors plus endocrine therapy, and patients with HR-negative disease must have received 1 line of therapy in the metastatic setting (progression on or within 6 months of neoadjuvant or adjuvant therapy will be accounted for as 1 line of prior therapy). There is no limit on number of subsequent lines of therapy for study entry. .\n7. Patients must have never been previously treated with any anti-HER2 therapy, including prior trastuzumab deruxtecan, other HER2-directed ADCs, HER2 antibodies or HER2 tyrosine kinase inhibitors\n8. Clinical or radiologic progression (during or after most recent treatment) or intolerance to therapy prior to enrollment in this trial\n9. Adequate archival tumor sample \\\u003C3 years-old available for assessment of HER2 status by IHC and by HS-HER2 quantitative assay. If archival tissue is not available or inadequate for assessment (e.g. decalcified bone, cytology, or other), a newly obtained biopsy from a metastatic site (or breast tissue if locally advanced\u002Funresectable disease as the only site of advanced disease) is required on enrolment.\n10. Presence of at least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n11. ECOG PS ≤ 2.\n12. Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to C1D1.\n13. Adequate bone marrow function (Table 1) within 28 days before C1D1, defined as:\n\n    1. Platelet count \\>≥100,000\u002Fmm3 (Platelet transfusion is not allowed within 1 week prior to Screening assessment).\n    2. Hemoglobin level ≥9.0 g\u002FdL (red blood cell transfusion is not allowed within 1 week prior to Screening assessment).\n    3. Absolute neutrophil count ≥1500\u002Fmm3 (granulocyte colony-stimulating factor administration is not allowed within 1 week prior to Screening assessment).\n14. Adequate renal function (Table 1) within 28 days before C1D1, defined as:\n\n    a. Creatinine clearance ≥30 mL\u002Fmin, as calculated using the Cockcroft-Gault Equation.\n15. Adequate hepatic function (Table 1) within 28 days before C1D1, defined as:\n\n    1. Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3×ULN (\\\u003C 5×ULN in participants with liver metastases).\n    2. Total bilirubin ≤1.5 × ULN if no liver metastases or \\\u003C3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.\n16. Adequate blood clotting function( defined below) within 28 days before C1D1, defined as International normalized ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN.\n\n    1. Platelet function greater than or equal to 100000\u002Fmm3 (Platelet transfusion is not allowed within 1 week prior to C1D1).\n    2. Hemoglobin greater than or equal to 9.0 g\u002FdL NOTE: Participants requiring ongoing transfusions or growth factor support to maintain haemoglobin ≥9.0 g\u002FdL are not eligible. Red blood cell transfusion is not allowed within 1 week prior to C1D1.\n    3. Absolute neutrophil count greater than or equal to 1500\u002Fmm3. (granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1).\n    4. Alanine aminotransferase and aspartate aminotransferase less than or equal to 3×ULN (\\\u003C 5×ULN in participants with liver metastases).\n    5. Total bilirubin less than or equal to 1.5×ULN if no liver metastases or \\\u003C 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.\n    6. Serum albumin greater than or equal to 2.5 g\u002FdL\n    7. Creatine clearance greater than or equal to 30 mL\u002Fmin as determined by Cockcroft Gault (using actual body weight).\n    8. International normalised ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time less than or equal to 1.5 x upper limit of normal\n17. Adequate treatment washout period before C1D1, defined below:\n\n    1. Major surgery minimum washout period of greater than or equal to 4 weeks\n    2. Radiation therapy including palliative stereotactic radiation therapy to chest minimum washout period greater than or equal to 4 weeks\n    3. Palliative stereotactic radiation therapy to other anatomic areas including whole brain radiation minimum wash out period of greater than or equal 2 weeks\n    4. Anti-Cancer chemotherapy \\[Immunotherapy (non-antibody based therapy)\\], hormonal therapy, antibody-based therapy, or retinoid therapy minimum washout period greater than or equal to 3 weeks\n    5. Anti-Cancer chemotherapy \\[Immunotherapy (non-antibody based therapy)\\], hormonal therapy, antibody-based therapy, or retinoid therapy minimum washout period greater than or equal 3 weeks\n    6. Targeted agents and small molecules minimum washout period greater than or equal 2 weeks or 5 half-lives, whichever is longer\n    7. Cell-free and Concentrated Ascites Reinfusion Therapy (CART), peritoneal shunt or drainage of pleural effusion, ascites or pericardial effusion minimum washout period greater than or equal to 2 weeks prior to screening assessment\n    8. Any monoclonal antibody treatment minimum washout period greater than or equal to 3 elimination half-lives of the inhibitor\u002Fantibody\n18. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU\u002FmL) must be available at the screening visit and urine beta-human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of T-DXd. Women of childbearing potential are defined as those who are not surgically sterile (i.e. underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n19. Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 3 from the time of screening (those using hormonal methods must have been stable on their chosen form of contraception for 3 months prior to study entry) and must agree to continue using such precautions for 7 months after the last dose of T-DXd. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of T-DXd. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n20. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom from screening to 4 months after the final dose of T-DXd. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. It is strongly recommended for the female partners of a male patient to also use at least one highly effective method of contraception throughout this period, as described in Table 3. In addition, male patients should refrain from fathering a child or freezing or donating sperm from the time of enrolment, throughout the study and for 4 months after the last dose of T-DXd. Preservation of sperm should be considered prior to enrolment in this study.\n21. Female subjects must not donate, or retrieve for their own use, ova from the time of enrolment and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrolment in this study.\n\nExclusion Criteria:\n\n1. Uncontrolled or significant cardiovascular disease, including any of the following:\n\n   1. History of myocardial infarction within 6 months before enrolment.\n   2. History of symptomatic congestive heart failure (New York Heart Association Class II to IV).\n   3. Corrected QT interval (QTc) Fridericia prolongation to \\>470 ms (females) or \\>450 ms (male) based on average of Screening 12 lead ECG.\n2. Uncontrolled or significant respiratory disease criteria, including any of the following:\n\n   1. Has a history of (noninfectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.\n   2. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g. severe asthma, severe chronic obstructive pulmonary disorder, restrictive lung disease, symptomatic, recurrent and uncontrolled pleural effusion etc.)\n   3. Any autoimmune, connective tissue or inflammatory disorders, including Rheumatoid arthritis, Sjogren's, and sarcoidosis, where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for participants who are included in the study.\n   4. Prior pneumonectomy (complete)\n3. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids to control associated symptoms.\n\n   1. Subjects with clinically inactive brain metastases may be included in the study.\n   2. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrolment.\n4. Has history of another primary malignancy, except for:\n\n   1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n   3. Adequately treated carcinoma in situ without evidence of disease.\n5. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product, or history of severe hypersensitivity reactions to monoclonal antibodies.\n6. Has an uncontrolled infection requiring ongoing IV antibiotics, IV antivirals, or IV antifungals.\n7. Has known history of human immunodeficiency virus (HIV) infection with detectable viral load or CD4 count \\\u003C 200 cells per cubic millimeter or active hepatitis B ( HBsAg positive) or C (HCV positive RNA) infection.\n8. Substance abuse, medical conditions such as clinically significant cardiac or pulmonary diseases or psychological, social, familial, or geographical conditions, that would, in the opinion of the Investigators, increase the safety risk to the subject or interfere with the subject's participation in the clinical study or evaluation of the clinical study results.\n9. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator \\[e.g., Grade 2 chemotherapy-induced neuropathy, fatigue, residual endocrinopathies from use of immunotherapy such as hypothyroidism\u002Fhyperthyroidism, type 1 diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)\\].\n10. Is pregnant or breastfeeding, or planning to become pregnant.\n11. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study intervention. Note: Participants, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of study intervention.\n12. Otherwise considered inappropriate for the study by the Investigator.",{"count":98,"type":22},40,[100],"PHASE2","The purpose of this study is to test the good and bad effects of a drug called trastuzumab deruxtecan (T-DXd) in adult patients with metastatic HER2-negative breast cancer and which patients might benefit the most from T-DXd.",[34],[104],"HER2-IHC 0","2026-06-25",{"date":79,"type":42},{"date":108,"type":42},"2025-06-20",{"date":110,"type":22},"2028-12-31",{"name":112,"class":49},"Yale University",3,{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":61,"phases":124,"briefSummary":126,"conditions":127,"keywords":131,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":113},"100641445","decision-support-tool-for-patients-with-advanced-breast-cancer-100641445","NCT07635147","Decision Support Tool for Patients With Advanced Breast Cancer","Communicating Options for Advanced Breast Cancer Support and Treatment (COAST)","COAST","Inclusion Criteria:\n\n* Male or female 18 years and older\n* Diagnosis of Stage IV breast cancer\n* English, Spanish or Mandarin speaking\n\nExclusion Criteria:\n\n* Early breast cancer\n* Individuals speaking languages other than English, Spanish, or Mandarin as their primary language",{"count":123,"type":22},100,[125],"NA","The goal of this pilot study is to understand and improve the shared decision-making process between people with advanced breast cancer and their providers regarding their care and treatment. As part of this study, the researchers will evaluate a decision support tool called COAST that was designed to support patients and providers in having meaningful conversations. The main questions it aims to answer are:\n\n1. Can the COAST tool improve the quality of communication between patients and their oncology providers?\n2. Is the COAST tool acceptable, appropriate, and easy to use at NYP-Weill Cornell Medicine, NYP-Brooklyn Methodist Hospital and NYP-Queens?\n\nParticipants will be asked to fill out two surveys: one before they use the COAST tool and another about 2 - 4 weeks later. Some patients will also be invited for an interview.",[34,128,129,130],"Advanced Breast Cancer","Stage 4 Breast Cancer","Stage IV (Metastatic) Breast Cancer",[132,133,134,135],"Decision support tool","advanced breast cancer","communication","Treatment preferences","2026-06-18",{"date":138,"type":42},"2026-06-22",{"date":140,"type":22},"2026-06",{"date":142,"type":22},"2028-02",{"name":144,"class":49},"Weill Medical College of Cornell University",{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":154,"conditions":155,"keywords":161,"overallStatus":163,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":167,"leadSponsor":169,"locationsCount":50},"100642337","quality-of-life-for-patients-with-breast-cancer-brain-metastases-and-leptomeningeal-disease-100642337","NCT07659652","Quality of Life for Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease","Prospective Evaluation of Quality of Life in Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease","Inclusion Criteria:\n\n1. Be male or female 18 years of age or older.\n2. Have stage 4 (metastatic) breast cancer with spread to the brain parenchyma and\u002For leptomeninges.\n3. Have the intention to start or continue anticancer therapy.\n4. Be able to provide informed consent.\n5. Be able to speak and read English.\n\nExclusion Criteria:\n\nParticipants who are not on any anticancer therapy and are not planning to start any anticancer therapy will be excluded from the study.",{"count":153,"type":22},200,"Central nervous system (CNS) metastases including breast cancer brain metastases (BCBMs) and leptomeningeal disease (LMD) are common affecting up to 30% of patients with metastatic breast cancer (MBC). The goal of this research is to understand symptom burden and quality of life trajectories in this population and how treatments guide care management decisions.",[156,157,158,159,160],"Breast Cancer, Quality of Life","Breast Cancer, Metastatic","Breast Cancer, Metastatic Breast Cancer","Leptomeningeal Metastasis of Breast Cancer","Brain Metastases From Breast Cancer",[162],"Quality of Life","NOT_YET_RECRUITING","2026-06-15",{"date":138,"type":42},{"date":164,"type":22},{"date":168,"type":22},"2035-12-31",{"name":170,"class":49},"University of California, San Francisco",{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":61,"phases":181,"briefSummary":182,"conditions":183,"keywords":184,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100593524","phase-2-aspen-09-03-a-study-of-evorpacept-in-combination-with-trastuzumab-and-chemotherapy-in-metastatic-her2-positive-breast-cancer-100593524","NCT07007559","ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer","Protocol ASPEN-09-03: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Participants With Metastatic HER2-Positive Breast Cancer, a Substudy Under Master Protocol ASPEN-09: A Phase 1b\u002F2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced \u002F Metastatic Malignancies","ASPEN-09-03","Inclusion Criteria:\n\n* Histologically confirmed invasive HER2+ breast cancer.\n* Received at least one prior line of therapy including T-DXd (ENHERTU) for locally advanced\u002Fmetastatic HER2+ breast cancer. Prior neoadjuvant therapy which resulted in relapse within 6 months of completion of T-DXd will be considered a line of treatment for metastatic disease. Participants who discontinue T-DXd due to intolerance are considered eligible.\n* Progressed on or following the most recent line of therapy.\n* Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine).\n* Measurable disease as defined by RECIST v1.1.\n* LVEF ≥50%.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1.\n* Life expectancy of at least 3 months.\n* Adequate renal function (estimated creatinine clearance ≥30 mL\u002Fmin as calculated using the Cockcroft-Gault equation or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n* Adequate liver function:\n\n  * Total bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if the participant has documented Gilbert syndrome);\n  * Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease).\n* Participants must have recovered from all AEs due to previous therapies, procedures, and surgeries to baseline severity or ≤Grade 1 per NCI CTCAE v5.0 except for AEs not deemed reversible and which do not constitute a safety risk by Investigator judgment.\n\nExclusion Criteria:\n\n* Participants with known CNS metastases unless treated and stable prior to enrollment.\n* Prior exposure to any anti-CD47 or anti-SIRPα agent.\n* Any condition that would be contraindicated to receiving trastuzumab\n* Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen\n* Following anti-cancer therapy with insufficient washout before start of treatment:\n\n  1. chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of start of treatment.\n  2. Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days or 5 half-lives (whichever is shorter) of start of treatment).\n* History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction.\n* Had an allogeneic tissue\u002Fsolid organ transplant.\n* Any active, unstable cardiovascular disease.\n* Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients).\n* Has an active autoimmune disease that has required systemic treatment in past 2 years.\n* Other primary malignancy within 2 years.",{"count":180,"type":22},120,[100],"The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting.\n\nASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows:\n\n* Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.\n* Recurrent\u002Fmetastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.",[157],[185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201],"metastatic","Her2+","metastatic HER2-positive breast cancer","breast cancer","HER2-positive","Evorpacept","CD47","ERBB2","Enhertu","trastuzumab deruxtecan","ASPEN-09","Herceptin","solid tumors","trastuzumab","ALX148","mBC","ASPEN-Breast","2026-06-04",{"date":204,"type":42},"2026-06-05",{"date":206,"type":42},"2025-12-10",{"date":208,"type":22},"2028-12",{"name":210,"class":88},"ALX Oncology Inc.",44,{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":61,"phases":221,"briefSummary":222,"conditions":223,"keywords":230,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":241},"100568211","phase-1-a-study-of-abemaciclib-and-radiation-therapy-in-people-with-metastatic-breast-cancer-100568211","NCT06678269","A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer","A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer","Inclusion Criteria:\n\n* Aged ≥18 years at signing of informed consent.\n* Both male and female patients are allowed\n* Histologically confirmed metastatic breast cancer (mBC), current stage IV.\n* Plan for ablative radiotherapy (SBRT) to a bone metastasis.\n* Documented estrogen receptor (ER) positive and\u002For progesterone receptor (PgR) positive by immunohistochemistry. The threshold to qualify as ER or PgR positive is ≥1% per ASCO\u002FCAP guidelines.\n* HER2 negative tumor status confirmed by immunohistochemistry or FISH per ASCO\u002FCAP guidelines.\n* Any line of prior treatments (hormonal therapy and chemotherapy) is permitted including prior abemaciclib, palbociclib and ribociclib.\n* At the time of enrollment, treating physician has intent to resume abemaciclib (at any dose) following radiotherapy.\n* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and enrollment (provided the patient did not receive radiotherapy).\n* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment. No prior radiotherapy to the current intended target site is permitted (ie. reirradiation is excluded from this study).\n* The patient must be able to swallow oral medications.\n* The patient must have adequate organ function per the following criteria (as defined in Table 2):\n\nTable 2: Laboratory Value Guidance to Establish Adequate Organ Function Hematologic ANC: ≥1.5 x 10\\^9\u002FL Platelets: ≥100 x 10\\^9\u002FL Hemoglobin: ≥8 g\u002FdL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.\n\nHepatic Total bilirubin: ≤1.5 x ULN Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted ALT and AST: ≤3 x ULN\n\n* Patient may remain on hormonal therapy and abemaciclib before enrollment.\n* Patients must discontinue other CDK4\u002F6 inhibitor (palbociclib or ribociclib) for at least 7 days and recover from the acute effects of therapy (until the toxicity resolves to ≤Grade 1) except for residual alopecia and peripheral neuropathy.\n* Measurable or non-measurable disease is permitted as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) status of ≤2 or Karnofsky Performance Status (KPS) ≥60.\n* Negative β-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause.\n* Women of childbearing potential must agree and commit to the use of a highly effective method of contraception as determined to be acceptable by the investigator, from the time of informed consent until 28 days after the last dose of the investigational product. Men must agree and commit to use a barrier method of contraception while on treatment and for 4 weeks after last dose of investigational products.\n* Patients (or their legally authorized representative) must provide written, informed consent to participate in the study and follow the study procedures\n* At the discretion of the treating radiation oncologist, radiation to a metastatic bone lesion is indicated inclusive of bone lesions in the spinal column.\n\nExclusion Criteria:\n\n* Treatment to bone lesions in the calvarium are not eligible for the dose-finding or expansion portions of the study. Patients who otherwise have calvarial lesions not undergoing treatment on this protocol are eligible to enroll.\n* Patients currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug\u002Fdevice used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n* The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to the start of study intervention, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.\n* Patients who received radiation therapy ≤14 days prior to initiation of investigational agents are excluded.\n* Patients are ineligible if they have serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n* Females who are pregnant or lactating.\n* The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening is not required for enrollment.\n* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n* Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 diarrhea of any etiology screening).\n* Malignant spinal cord compression (ESCC2 or above)\n* Prior radiation therapy to the current target site.",{"count":220,"type":22},28,[63],"The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.",[224,225,36,226,34,227,228,229],"Metastatic Breast Cancer","Stage IV Breast Cancer","Breast Cancer Stage IV","HER2-negative Breast Cancer","HER2 Negative Breast Carcinoma","Hormone-receptor-positive Breast Cancer",[224,225,36,226,34,227,228,229,231,232],"Memorial Sloan Kettering Cancer Center","24-138","2026-05-26",{"date":235,"type":42},"2026-05-28",{"date":237,"type":42},"2024-11-15",{"date":239,"type":22},"2028-11-30",{"name":231,"class":49},7,{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":50},"100637982","her2-pet-predicting-t-dxd-efficacy-and-her2-heterogeneity-100637982","NCT07586215","HER2-PET: Predicting T-DXd Efficacy and HER2 Heterogeneity","Study on Using HER2-PET to Predict the Efficacy of T-DXd Treatment in Advanced Breast Cancer and to Investigate the Heterogeneity of HER2 Expression","PREDICT-HER","Inclusion Criteria:\n\n1. Aged ≥ 18 years.\n2. Histologically confirmed unresectable locally advanced or metastatic breast cancer, with immunohistochemistry (IHC) results indicating HER2-positive (IHC 3+; or IHC 2+ and FISH-positive) or HER2-low expression (IHC 1+; or IHC 2+ and FISH-negative).\n3. Prior treatment meeting one of the following criteria:\n\n   3.1 For HER2-positive breast cancer, patients must have received at least one prior anti-HER2 targeted therapy.\n\n   3.2 For HER2-low breast cancer, patients must have received at least one prior line of systemic therapy for metastatic disease, or have relapsed within 6 months during or after completion of adjuvant chemotherapy.\n4. ECOG Performance Status of 0 or 1.\n5. Evidence of radiographic or objective disease progression at or after the last systemic therapy prior to initiating study treatment.\n6. Anticipated life expectancy ≥ 12 weeks at screening.\n7. At least one measurable lesion that has not been previously irradiated, with a longest diameter ≥ 10 mm as accurately measured by CT or MRI at baseline (except for lymph nodes, which must have a short axis ≥ 15 mm). Alternatively, if only bone lesions are present, evaluable osteolytic or mixed osteolytic\u002Fblastic bone lesions as assessed by CT, MRI, or X-ray are acceptable.\n8. Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to randomization.\n9. Adequate organ and bone marrow function within 14 days prior to randomization. For all parameters listed below, the most recent results must be used to meet the inclusion criteria:\n\n   1. Hemoglobin ≥ 9 g\u002FdL;\n   2. Absolute Neutrophil Count (ANC) ≥ 1500\u002Fmm3;\n   3. Platelet count ≥ 100,000\u002Fmm3;\n   4. Total bilirubin (TBL) ≤ 1.5 × Upper Limit of Normal (ULN) at baseline in the absence of liver metastases; or \\\u003C 3 × ULN in the presence of Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases;\n   5. ALT and AST ≤ 3 × ULN; or \\\u003C 5 × ULN for patients with liver metastases;\n   6. Serum albumin ≥ 2.5 g\u002FdL;\n   7. Creatinine clearance ≥ 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n   8. International Normalized Ratio (INR) or Prothrombin Time (PT), and Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN.\n10. Female patients must not donate eggs or collect eggs for personal use from the screening period throughout the study treatment period and for 7 months after the last dose of study treatment. Breastfeeding should be avoided during this period. If oocyte preservation is desired, it should be considered prior to randomization in this study.\n\nExclusion Criteria:\n\n1. Uncontrolled concurrent diseases, including but not limited to: persistent or active infections, uncontrolled or significant cardiovascular disease, severe chronic gastrointestinal disease with diarrhea, or psychiatric\u002Fsocial conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or impair the patient's ability to provide written informed consent.\n2. Uncontrolled or significant cardiovascular disease, including any of the following:\n\n   1. History of myocardial infarction or symptomatic congestive heart failure (CHF) (NYHA Class II to IV) within 6 months prior to randomization. Patients with troponin levels above the Upper Limit of Normal (ULN) (as defined by the manufacturer) at screening without any symptoms related to myocardial infarction should undergo cardiac consultation prior to randomization to rule out myocardial infarction;\n   2. Uncontrolled hypertension;\n   3. Uncontrolled and\u002For clinically significant arrhythmias.\n3. History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis requiring steroid treatment, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n4. Patients who have used immunosuppressive agents within 14 days prior to the first dose of study drug, with the exception of those using intranasal and inhaled corticosteroids, or systemic corticosteroids at a dose less than 10 mg\u002Fday prednisone or an equivalent dose.\n5. Clinically significant pulmonary-specific comorbidities, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within three months prior to randomization, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, significant pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disease with associated pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), and\u002For prior lung resection.\n6. Uncontrolled infection requiring intravenous antibiotics, antiviral, or antifungal medications.\n7. Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring corticosteroid or anticonvulsant treatment to control associated symptoms. Subjects with clinically non-active brain metastases may be included in this study. If subjects have received treatment for brain metastases, are no longer symptomatic, do not require corticosteroids or anticonvulsants, and have recovered from acute toxicities of radiotherapy, they may be enrolled in this study.\n8. Active primary immunodeficiency, known Human Immunodeficiency Virus (HIV) infection, or active Hepatitis B or C infection. Among patients who are Hepatitis C antibody positive, only those with a negative polymerase chain reaction (PCR) for HCV RNA are eligible for study enrollment.\n9. Unresolved toxicities from prior anti-cancer therapy, defined as toxicities not resolved to ≤ Grade 1 or baseline (excluding alopecia).\n\n   Note: Subjects with chronic, stable Grade 2 toxicities (defined as not worsening to ≥ Grade 2 for at least 3 months prior to enrollment and manageable with standard treatment) that are deemed by the investigator to be related to prior anti-cancer therapy may be included, e.g., chemotherapy-induced neuropathy or fatigue; residual toxicity from prior immunosuppressive therapy: Grade 1 or 2 endocrine disorders.\n10. Pregnant or lactating female patients, or patients planning pregnancy. Known history of severe hypersensitivity reaction to the active pharmaceutical ingredient (API), excipients in the drug formulation, or other monoclonal antibodies.\n11. History of another primary malignancy within 3 years, with the exception of adequately treated non-melanoma skin cancer, cured in situ disease, other cured solid tumors, or contralateral breast cancer.\n12. Substance abuse or any other medical condition that, in the opinion of the investigator, might interfere with the patient's participation in the clinical study or the evaluation of the clinical study results, e.g., psychiatric disorders.",{"count":123,"type":22},"The study will be conducted as an open-label, single-center, Phase II clinical study, with a planned enrollment of 70 patients with locally advanced or metastatic HER2-positive and HER2-low breast cancer who are intended to receive at least two cycles of T-DXd monotherapy. All patients receiving T-DXd treatment must meet current clinical indications. After screening and enrollment, participants will undergo FDG-PET scans and free-of-charge HER2-PET scans prior to T-DXd treatment, with tissue biopsies performed as needed. Participants will receive single-agent T-DXd treatment until disease progression, with additional tissue biopsies performed as needed.This study will integrate and analyze patients' baseline clinical characteristics, treatment efficacy, and prognostic information, along with HER2 expression levels and HER2 expression heterogeneity as assessed by HER2-PET, to evaluate the feasibility of guiding T-DXd treatment in patients with advanced breast cancer.",[34],"2026-05-10",{"date":255,"type":42},"2026-05-14",{"date":257,"type":42},"2024-11-11",{"date":259,"type":22},"2026-12-11",{"name":261,"class":49},"Fudan University",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":269,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":61,"phases":272,"briefSummary":273,"conditions":274,"keywords":277,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":50},"100578146","evaluation-of-circulating-tumor-cells-ctc-relevance-in-breast-cancer-follow-up-using-the-screencell-device-100578146","NCT06807502","Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device","PROBE-CTC","INCLUSION CRITERIA\n\nFor all participants :\n\n* Female with age greater than or equal to 18 years\n\nFor participants with metastatic breast cancer:\n\n\\- Patient observed with metastatic breast cancer from the outset or metastatic fall from previously treated breast cancer with change of therapeutic line at the time of inclusion.\n\nFor participants with non-metastatic invasive breast cancer:\n\n\\- Patient observed with non-metastatic infiltrative breast cancer who had not received any treatment at the time of inclusion (naïve to any treatment)\n\nFor healthy volunteers:\n\n* Participant free of any cancer at the time of inclusion, confirmed using a mammogram whose results must be satisfactory, done at the latest two years before inclusion\n* Participant with no history of cancer\n\nEXCLUSION CRITERIA\n\nFor all participants:\n\n* Male\n* Age less than 18 years old\n* Refusal to participate or withdrawal of consent\n* Pregnant and\u002For breastfeeding women\n* Discovery of a cancerous pathology (other than breast cancer for patients) during participant follow-up.\n\nFor healthy volunteers:\n\n* History of cancer\n* Detection of CTC (positive profile) during screening",true,{"count":271,"type":22},93,[125],"Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up.\n\nThe identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up",[157,275,276],"Breast Cancer Invasive","Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[278,279,280,36,281,282,283],"CTC","Circulating Tumor Cells","Detection","Follow-up","Liquid Biopsy","Blood Test","2026-04-21",{"date":286,"type":42},"2026-04-24",{"date":288,"type":42},"2025-02-24",{"date":290,"type":22},"2026-11-30",{"name":292,"class":88},"ScreenCell",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":61,"phases":303,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":163,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":4},"100607526","plant-based-nutrition-for-breast-or-endometrial-cancer-100607526","NCT07189702","Plant-Based Nutrition for Breast or Endometrial Cancer","A Randomized Controlled Trial of Behavioral Education and Nutrition Delivery in Women With Metastatic Breast and Endometrial Cancer. (The BEND-MBEC Study)","BEND-MBEC","Inclusion Criteria: • Female sex (as assigned at birth), aged 18 years or older\n\n* A confirmed diagnosis of endometrial or metastatic breast cancer. All subtypes are eligible\n* Treating oncologist approval and expected survival of at least six months\n* Undergoing any systemic treatment including hormonal, cytotoxic, targeted monoclonal antibody or small molecule kinase inhibitors or any combination of the above. Women who have active cancer and have been recommended but declined systemic treatment are also eligible.\n* Willing to adopt a strict, whole-foods, plant-based diet\n* Willing and able to comply with the WFPB protocol for the duration of the study including scheduled testing, Zoom meetings, and office visits\n* Able to speak and read English fluently.\n* Women with plans for radiation therapy or surgery are also eligible provided that they meet all other eligibility criteria.\n\nExclusion Criteria: • BMI ≤ 20.0 kg\u002Fm2\n\n* Inability to tolerate a normal diet\n* Active malabsorption syndrome at time of consent, as determined by study physicians (i.e. Crohn's disease, bowel surgery)\n* Any food allergies or intolerances that would interfere with study compliance\n* Recent consumption (in the past six months) of a vegan diet\n* eGFR \\\u003C 30 on ≥ two lab tests in the past six months\n* Serum potassium \\> 5.4 in the past six months\n* Current insulin or sulfonylurea use\n* Current warfarin use (non-vitamin K antagonist allowed)\n* High-risk alcohol use (\\>7 drinks\u002Fwk)\n* Illicit substance use (not including marijuana)\n* Cognitive impairment or psychiatric disorder impairing ability to give consent.",{"count":302,"type":22},60,[125],"This is a randomized controlled trial of a whole food, plant-based (WFPB) dietary intervention among women with metastatic breast or endometrial cancer.",[34,306],"Endometrial Cancer Stage IV",[308,309,310,311,312,313,314],"Metastatic","Metastatic Breast","Metastatic Endometrial","Breast Stage IV","Endometrial Stage IV","Nutrition","Plant-Based Nutrition","2026-04-07",{"date":317,"type":42},"2026-04-08",{"date":319,"type":22},"2026-12",{"date":321,"type":22},"2030-12",{"name":323,"class":49},"University of Rochester",{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":61,"phases":332,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":343,"locationsCount":113},"100573469","phase-1-a-first-in-human-clinical-trial-assessing-the-safety-of-es2b-c001-s01-with-or-without-adjuvant-in-patients-with-her2-expressing-metastatic-breast-cancer-100573469","NCT06746688","A First-in-human, Clinical Trial Assessing the Safety of ES2B-C001-S01 With or Without [Adjuvant] in Patients With HER2-expressing Metastatic Breast Cancer.","A First-In-Human Phase I, Open-Label, Dose-Escalating Trial to Assess the Safety, Tolerability and Immunogenicity\u002FPreliminary Antitumor Activity of ES2B-C001 With or Without [Adjuvant] in HER2-expressing Metastatic Breast Cancer","Inclusion Criteria:\n\n* Patients aged ≥18 years at screening visit.\n* Diagnosis of HER2-expressing locally advanced, unresectable, or metastatic BC, with HER2 IHC level 1+, 2+ (either FISH negative or positive), or IHC level 3+, after undergoing 2-3 lines of anticancer therapy.\n* Life expectancy of at least 3 months.\n* ECOG performance status 0-2.\n* Patients have adequate bone marrow, kidney, liver, heart, and lung function without clinically significant laboratory parameters as judged by the investigator.\n* 12-lead ECG without clinically significant abnormalities and no LBBB, QRS duration \\>140ms, or evidence of prior infarction.\n* Recovered from side effects, adverse reactions, or adverse events due to prior therapy and\u002For surgery; any residual toxicities and toxicities related to current anticancer treatment must be ≤ Grade 2, except for alopecia, neuropathy or lymphoedema.\n* If female, non-pregnant, postmenopausal, or practicing reliable contraception.\n* If male, sterilized or using reliable contraception.\n\nExclusion Criteria:\n\n* Any planned intravenous chemotherapy regimens or check point inhibitors, or previous therapy with those agents during the past 1 month and the patients are neutropenic. Maintenance therapy with a stable dose of HER2-directed mAbs or treatment with antibody drug conjugates (ADCs) for metastatic BC is allowed at the discretion of the treating physician.\n* Symptomatic CNS metastatic disease requiring treatment with high dose steroids (i.e., above 10 mg of prednisone or equivalent) within 14 days prior to first administration of ES2B-C001 (with or without adjuvant).\n* Concurrent or recent (within 21 days or 5 half-lives) involvement in any other clinical trial with an investigational drug, device, or other experimental intervention.\n* Concomitant severe or uncontrolled underlying medical and\u002For mental disease unrelated to the tumor, which in the opinion of the investigator is likely to compromise patient safety and affect the trial's outcome.\n* Previous documented coronary artery disease or congestive heart failure (\\>NYHA II).\n* Echocardiography with LVEF \\\u003C55%.\n* Uncontrolled hypertension.\n* Active, known, or suspected autoimmune disease, except thyroid conditions sufficiently controlled on thyroid hormone therapy, and controlled insulin dependent diabetes.\n* Necessity for long-term immunosuppression (≤ 4 mg dexamethasone may be used transiently).\n* Systemic infection requiring intravenous antibiotics within 14 days before dosing.\n* Chronic use of anti-viral agents, except for human immunodeficiency virus (HIV) or hepatitis B or C virus (HBV, HCV) treatments.\n* History of severe hypersensitivity reactions to any of the trial drug components.\n* Has received a live or live-attenuated vaccine within 30 days prior to the first dose of trial treatment. Note: Administration of inactivated or recombinant vaccines\u002Fkilled vaccines are allowed.\n* Birthmarks, tattoos, wounds, or skin conditions on deltoid region\u002Fbuttocks that may obscure the assessment of injection site reactions.\n* Female patients who are pregnant, or lactating.\n* Any infection (including SARS-CoV-2), that in the opinion of the investigator would, upon inclusion in the trial, lead to potentially harming patients' safety or integrity.",{"count":98,"type":22},[63],"The trial is a first-in-human, phase I, open-label, dose-escalating trial to assess the safety and tolerability of ES2B-C001 combined with or without \\[adjuvant\\], in patients with human epidermal growth factor receptor 2 (HER2) expressing metastatic breast cancer.",[36,34],[188,336,337],"MBC","metastatic breast cancer",{"date":339,"type":42},"2026-04-13",{"date":341,"type":42},"2025-06-03",{"date":319,"type":22},{"name":344,"class":88},"ExpreS2ion Biotechnologies",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":61,"phases":355,"briefSummary":357,"conditions":358,"keywords":361,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":374},"100521670","phase-3-study-of-the-bria-imt-regimen-and-cpi-vs-physicians-choice-in-advanced-metastatic-breast-cancer-100521670","NCT06072612","Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.","Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.","BRIA-ABC","Inclusion Criteria:\n\n1. Be ≥ 18 years of age.\n2. Have signed informed consent.\n3. Have histological confirmation of breast cancer with either locally recurrent unresectable and\u002For metastatic lesions, and have failed prior therapy:\n\n   * Patients with persistent disease and local recurrence must not be amenable to local treatment.\n   * For patients with metastatic disease, late-stage MBC with no meaningful alternative therapies available and the following class specific treatment histories:\n\n     1. Human epidermal growth factor 2 (HER2) positive must be previously treated with at least 3 regimens containing at least two anti-HER2 and at least one chemotherapy containing regimen.\n     2. Estrogen receptor (ER), progesterone receptor (PR) positive tumors: must be refractory to hormonal therapy demonstrated by progression on at least 2 hormonal agents in 2 separate lines of hormone directed therapy.\n     3. Triple Negative tumors: Must have exhausted all curative intent therapies including at least 2 prior chemotherapy regimens, which can include regimens in neoadjuvant and adjuvant settings.\n     4. Cancers with known germline or genomic actionable targets, e.g. g\u002FmBRCA, must have been treated with all tumor directed indicated treatment e.g. PARPi, if tolerated.\n     5. HER2 low patients, in addition to the appropriate therapies based on ER\u002FPR status and germline or genomic actionable targets, must also have received at least one HER2-targeted agent approved for treatment of HER2 low patients.\n     6. HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens.\n     7. Patients with new or progressive breast cancer metastatic to the brain will be eligible provided:\n\n        * The brain metastases must be clinically stable (without evidence of progressive disease by imaging for at least 4 weeks prior to first dose)\n        * There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose\n        * Tumor is not impinging on Middle Cerebral Artery\u002Fspeech-motor strip\n        * If surgically debulked, must be healed with at least 3 weeks since surgery prior to the first dose\n4. Has expected survival of at least 4 months.\n5. ECOG performance status of 0, 1 or 2\n\nExclusion Criteria:\n\n1. Concurrent or recent chemotherapy, immunotherapy or major surgery within 21 days prior to the first dose.\n2. Radiotherapy within 14 days of the first dose of study treatment.\n3. Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support).\n4. Any toxicity to prior CPI that was grade 3 or higher unless it has been successfully treated (e.g. hypothyroidism or hypopituitarism treated with replacement therapy), .\n5. Toxicity to prior CPI that has not resolved to grade 1 or less except for stable asymptomatic endocrinopathies.\n6. History of clinical hypersensitivity to the designated therapy as specified in the protocol, including the proposed TPC, beef, or to any components used in the preparation of SV- BR-1-GM.\n7. History of hypersensitivity to any of the therapies proposed for treatment in this study.\n8. Serum creatinine OR Measured OR calculated Creatinine Clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) \\>2.0 × ULN or \\\u003C30 mL\u002Fmin for participants with creatinine levels \\>2.0 × institutional ULN.\n9. Absolute granulocyte count \\\u003C1000; platelets \\\u003C80,000; hemoglobin ≤ 7 g\u002FL.\n10. Bilirubin ≥ 2 × ULN unless conjugated bilirubin ≤ ULN; alkaline phosphatase \\>5x upper limit of normal (ULN); ALT\u002FAST \\>3x ULN. For patients with hepatic metastases, ALT\u002FAST \\>5x ULN is exclusionary.\n11. INR or PT or aPTT \\> 1.8 × ULN, unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.\n12. Receiving any medication listed in the prohibited medication section of the protocol.\n13. Proteinuria \\>2+ on urinalysis\n14. A history or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. Screening corrected QT interval (QTc) interval \\>480 milliseconds is excluded (corrected by Fridericia or Bazett formula). In the event that a single QTc is \\>480 milliseconds, the participant may enroll if the average QTc for the 3 ECGs is \\\u003C480 milliseconds.\n15. New York Heart Association stage 3 or 4 cardiac disease.\n16. A pericardial effusion of moderate severity or worse.\n17. Symptomatic pleural effusion or ascites. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.\n18. Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she agrees to take appropriate precautions to avoid becoming pregnant during the study and has a negative serum pregnancy test within 7 days prior to starting treatment.\n19. Men must have been sterile or, if they were potentially fertile\u002Freproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.\n20. Women who are pregnant or nursing.\n21. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for \\> 1 year, after treatment with curative intent.\n22. Patients who have uncontrolled HIV or have clinical or laboratory features indicative of AIDS.\n23. Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.\n24. Have an active autoimmune disease that has required systemic treatment in past year (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.\n25. Known active HAV, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization).\n26. Active infections requiring systemic therapy within the past 14 days.\n27. Patients with severe psychiatric disease (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator in consultation with the Medical Monitor.\n28. Has received a live vaccine within 28 days of the first dose of study drug.\n29. Patients may not be on a concurrent clinical trial, unless approved by the Investigator.",{"count":354,"type":22},404,[356],"PHASE3","This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor \\[Retifanlimab\\], versus Treatment of Patients'\u002FPhysicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.",[36,224,359,34,360],"Breast Neoplasm","End Stage Cancer",[362,185,363,364,365],"Breast","advanced","cancer","late line","2026-04-06",{"date":315,"type":42},{"date":369,"type":42},"2023-12-05",{"date":371,"type":22},"2028-06",{"name":373,"class":88},"BriaCell Therapeutics Corporation",79,{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":61,"phases":384,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":163,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":402,"leadSponsor":404,"locationsCount":4},"100583912","stereotactic-ablative-body-radiotherapy-sabr-with-maintenance-of-systemic-therapy-versus-physicians-choice-of-systemic-therapy-for-oligoprogressive-er-positive-her-2-negative-breast-cancer-ii-100583912","NCT06882499","Stereotactic Ablative Body Radiotherapy (SABR) With Maintenance of Systemic Therapy Versus Physicians' Choice of Systemic Therapy for Oligoprogressive ER-positive, Her-2 Negative Breast Cancer II","AVATARII","INCLUSION CRITERIA\n\nPatients will be eligible for inclusion in this trial if all the following criteria apply:\n\n1. Patient has signed the AVATAR-II Patient Information and Consent Form (PICF)\n2. Male or female, ≥ 18 years of age at the time signing consent\n3. Patients with histologically proven ER-positive, HER2-negative advanced breast cancer receiving an ET in combination with a CDK 4\u002F6 inhibitor. Biopsy of metastatic disease if technically feasible but not mandatory\n4. Patients must have evidence of extracranial metastatic disease, with no evidence of uncontrolled intracranial metastases. (Controlled intracranial metastases are defined as stable disease on repeat CT imaging performed at least one month apart.)\n5. Patients must have evidence of radiological response to ET and CDK 4\u002F6 inhibitor for a minimum of six months prior to randomisation (defined as either stable disease or partial response).\n\n   Note: Patient must have ongoing stability\u002Fresponse in at least one lesion at the time of randomisation.\n6. Evidence of new or existing OPD, as determined by the Investigator and defined according to RECIST1.1 (33), via CT on a per-lesion basis (between 1-5 metastases, including the primary) as follows:\n\n   * At least a 20% increase in the diameter of a lesion, taking as reference the smallest diameter on a previous CT scan with an absolute increase of at least 5mm\n   * Appearance of a new lesion(s) Note: A new lesion can be identified using various imaging modalities, such as PET-CT or WBBS, as long as the lesion is visible on serial CT scans.\n7. For patients with liver or lung metastases, maximum of 3 oligoprogressive lesions in single organ\n8. All OPD must be amenable to SABR, as per the radiotherapy guidelines in section 11.1 and Appendix 4 and 5\n9. ECOG performance status 0-2\n10. Life expectancy ≥ 6 months\n11. Clinician and patient are willing to continue current line of therapy\n12. Patient is able to complete QoL questionnaires, and other assessments required as part of the study\n\nEXCLUSION CRITERIA\n\nPatients will not be eligible for inclusion in this trial if any of the following criteria apply:\n\n1. Is pregnant or lactating at the time of randomisation\n2. Evidence of more than one clone of metastatic disease e.g., a patient with both ER-positive and triple negative clones of disease And ER-negative and\u002For HER2-positive disease would be excluded from the study\n3. Evidence of leptomeningeal disease\n4. Evidence of malignant cord compression\n5. Evidence of lesion within femoral bone requiring surgical fixation\n6. Patients with risk of bone fracture are not candidate for SABR (Appendix 4 and 5)\n7. Previous chemotherapy for metastatic disease Note: chemotherapy for primary breast cancer is allowed\n8. Contraindications to radiotherapy\n9. Any condition deeming the patient unsuitable to comply with the study\n10. Substantial overlap with previously treated area. Reirradiation is permitted with the condition that the combined plan adheres to the specific dose constraints outlined in this protocol. It is advised to use biological effective dose (BED) calculations to correlate previous doses with the tolerance doses documented in the protocol\n11. Evidence of progression in more than 5 lesions\n12. Prior SABR delivered for oligoprogressive disease with the intent of delaying a change in systemic therapy.",{"count":383,"type":22},74,[125],"The goal of this clinical trial is to assess Stereotactic Ablative Radiotherapy (SABR) as a method to delay a change in systemic therapy in patients with oligoprogressive ER-positive, HER2-negative advanced breast cancer. The main question it aims to answer is to assess whether the addition of SABR to continuation of first line endocrine therapy and CDK 4\u002F6 inhibitor (Arm A) to patients with oligoprogressive ER-positive, HER2-negative advanced breast cancer could have longer time to strategy failure (TSF) in comparison to physician choice of systemic treatment (Arm B) in patients who had progressed first line.\n\nThe treatment strategy in Arm A is to maintain patients on current endocrine therapy and CDK 4\u002F6 inhibitor, controlling localised progressing sites of disease with SABR. Treatment strategy in Arm B is to maintain disease control with physician's choice of systemic therapy alone.",[157,224],[388,389,390,391,392,393,394,395,396,397],"ER-positive, HER2-negative","selective estrogen receptor degrader","endocrine therapy","aromatase inhibitor","CDK 4\u002F6 inhibitor","SABR","oligoprogression","oligometastases","oligometastatic","sbrt","2026-03-31",{"date":400,"type":42},"2026-04-02",{"date":140,"type":22},{"date":403,"type":22},"2032-06",{"name":405,"class":49},"Peter MacCallum Cancer Centre, Australia",{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":61,"phases":414,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":50},"100572366","phase-1-her2-pet-imaging-in-her2-low-breast-cancers-100572366","NCT06732336","HER2-PET Imaging in HER2-low Breast Cancers","HER2-PET Imaging Using 89Zr-trastuzumab in Low HER2-expressing (HER2-low) Breast Cancers","Inclusion Criteria:\n\n* HER2-low metastatic breast cancer;\n* At least 18 years-old ;\n* Able to stay in supine position for at least 30 minutes;\n* Written inform consent.\n\nExclusion Criteria:\n\n* Pregnancy or concomitant breast feeding;\n* Hepatic disorders such as cirrhosis, hepatitis, or any other liver condition judged as significant by the treating physician and that could impair the biliary excretion of 89Zr-trastuzumab;\n* Renal disorders considered significant by the treating physician and that could impair the normal elimination of 89Zr-trastuzumab;\n* Known hypersensitivity or allergy to trastuzumab, desferrioxamine, or any constituents of 89Zr-trastuzumab.",{"count":98,"type":22},[63,100],"A strategy to target the oncogenic receptor HER2 using a version of the anti-HER2 therapeutic antibody trastuzumab coupled to desferrioxamine (DFO) and radiolabeled with zirconium-89 (\\[89Zr\\]-DFO-trastuzumab) has been successfully evaluated in our group in preclinical settings. Clinical studies by other groups in recent years have shown the potential of targeting HER2+ lesions with \\[89Zr\\]-DFO-trastuzumab in patients with HER2+ cancers. We now want to establish the diagnostic potential of a protocol adding \\[89Zr\\]-DFO-trastuzumab PET imaging to FDG PET already used in the clinic for the detection of HER2-expressing cancers, including low expression levels considered until now as HER2-negative (HER2-low, IHC score 1+ and 2+ without FISH amplification of the HER2 locus). The HER2-low status has recently gained relevance thanks to large studies showing the efficacy of immunotherapy combined with drugs such as Enhertu (trastuzumab-deruxtecan), while trastuzumab alone was traditionally only effective for HER2+ cancers (IHC score 2+\u002FFISH+, or 3+). In particular, we aim to develop a method to assess whole-body intertumoral heterogeneity in HER2 expression in order to detect cases with heterogeneous diseases and thus better stage patients and guide the optimal choice of personalized and targeted treatment to use. More specifically, the project aims to image with \\[89Zr\\]-DFO-trastuzumab PET patients with cancer, particularly breast cancer, but also esophageal, gastric, ovarian, endometrial and lung cancer, and whose primary tumor status is HER2-low.",[34],[418,419,420,421,422],"HER2","HER2-low","PET","Breast cancer","89Zr-trastuzumab","2026-03-30",{"date":398,"type":42},{"date":426,"type":42},"2024-12-01",{"date":428,"type":22},"2027-03-31",{"name":430,"class":49},"Centre de recherche du Centre hospitalier universitaire de Sherbrooke",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":61,"phases":441,"briefSummary":442,"conditions":443,"keywords":450,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":464},"100495736","phase-1-open-label-study-to-evaluate-the-safety-tolerability-pk-and-efficacy-of-inx-315-in-patients-with-advanced-cancer-100495736","NCT05735080","Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer","A Phase 1\u002F2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer","INX-315-01","Inclusion Criteria:\n\n1. Advanced unresectable or metastatic HR+\u002FHER2- BC that has progressed following treatment with a CDK4\u002F6 inhibitor in the adjuvant or advanced\u002Fmetastatic setting.\n2. Advanced\u002F metastatic platinum-resistant or platinum-refractory high grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with known amplification of CCNE-1 that progressed after standard systemic therapy\n3. Advanced or metastatic solid tumor with known amplification of CCNE-1 that has progressed after standard therapy, been intolerant to or is ineligible for standard therapy\n4. At least one measurable lesion as defined by RECIST v1.1 that has not previously been irradiated\n5. ECOG performance status score of 0 or 1.\n6. Adequate organ function as demonstrated by the following laboratory values:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL\n   2. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n   3. Platelet count ≥ 100 × 10\\^9\u002FL\n   4. Estimated glomerular filtration rate (eGFR) of ≥60 mL\u002Fmin\n   5. Part A and B: Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; ≤ 5 × ULN in the presence of liver metastases Part C: Patients with Gilbert's syndrome with a total bilirubin ≤ 2.0 × ULN and direct bilirubin within normal limits\n7. Negative pregnancy test\n\nExclusion Criteria:\n\n1. Have received previous therapy with a CDK2\u002F4\u002F6 inhibitor or CDK2 inhibitor.\n2. Have central nervous system (CNS) metastases or spinal cord compression that is associated with progressive neurological symptoms or requires corticosteroids (within 4 weeks of enrollment) to control the CNS disease.\n3. Have known intracranial hemorrhage and\u002For bleeding diatheses.\n4. Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.\n5. Have clinically active ongoing interstitial lung disease (ILD) of any etiology, including drug-induced ILD, and radiation pneumonitis within 28 days prior to initiation of study treatment.\n6. Resting QTcF \\> 470 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome.\n7. Uncontrolled, cardiovascular disease (including hypertension) with or without medication\n8. History of other malignancies, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for ≥ 3 years.\n9. Known HIV infection, including AIDS-related illness, or have active, uncontrolled infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B virus, hepatitis C virus, or COVID-19 infection (symptoms and a positive test result).\n10. Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration.\n11. Have planned or anticipation of the need for major surgical procedure within 28 days of the first dose of study drug (procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures).\n12. Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.\n13. Radical radiotherapy within 28 days prior to study entry or palliative radiotherapy within 2 weeks prior to study entry.\n14. Systemic anti-cancer therapy within 21 days or at least 5 half-lives, whichever is less, prior to the first dose of the study drug\n15. Prior irradiation to \\> 25% of the bone marrow\n16. Previous high-dose chemotherapy requiring prior stem cell transplant\n17. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry.\n18. Known or suspected hypersensitivity to active ingredient\u002Fexcipients in INX-315 or fulvestrant or abemaciclib.\n19. Known difficulty in swallowing or tolerating oral medications, or conditions which would impair absorption of oral medications such as active inflammatory gastrointestinal disease, uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder\u002Factive inflammation, malabsorption syndrome, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.\n20. Has a serious and\u002For uncontrolled pre-existing medical condition(s) that, in the judgment of the Investigator or the Sponsor, would preclude participation in this study (for example but not limited to, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)",{"count":440,"type":22},150,[63,100],"Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced\u002Fmetastatic cancer, including hormone receptor positive (HR+)\u002FHuman Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4\u002F6 inhibitor (CDK4\u002F6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care treatment. The study will be conducted in 3 parts: Part A (INX-315 monotherapy dose escalation and combination therapy with fulvestrant), Part B (ovarian cancer INX-315 monotherapy dose expansion), and Part C (INX-315 combination therapy with abemaciclib \\[a CDK4\u002F6i\\] and fulvestrant \\[a SERD\\] in advanced\u002Fmetastatic breast cancer; dose escalation and expansion).",[36,34,444,445,71,446,447,448,449],"Hormone Receptor Positive Tumor","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","CCNE1 Amplification","Solid Tumor","Advanced Cancer","Metastatic Cancer",[451,452,453,454],"CDK2","CDK4\u002F6i","cyclin dependent kinase 2","CCNE1","2026-03-27",{"date":457,"type":42},"2026-04-01",{"date":459,"type":42},"2023-03-28",{"date":461,"type":22},"2027-09",{"name":463,"class":88},"Incyclix Bio",18,{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":473,"targetDuration":475,"studyType":23,"phases":4,"briefSummary":476,"conditions":477,"keywords":478,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":50},"100574684","integrated-testing-strategy-for-simultaneous-detection-of-esr-1-and-gbrca-mutations-via-liquid-biopsy-in-hrher2--metastatic-breast-cancer-mbc-patients-100574684","NCT06762483","Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Liquid Biopsy in HR+\u002FHER2- Metastatic Breast Cancer (mBC) Patients,","Development and Validation of an Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Liquid Biopsy in HR+\u002FHER2- Metastatic Breast Cancer (mBC) Patients, and the Creation of a Digital Gene Library to Support an Evidence-based Diagnostic Algorithm","L2-268","Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of estrogen receptor-positive (ER+) and\u002For progesterone receptor-positive (PgR+) breast cancer through histological and\u002For cytological examination by the local laboratory Participants must exhibit HER2-negative breast cancer\n\n  1. or 2+). If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.\n\n     * Participants should be in an advanced or metastatic setting including both those prior to the initiation of treatment for metastatic disease and those who experienced progression following treatment with cyclin-dependent kinases (CDK)4\u002F6 inhibitors. However, the primary tumor should be treated according to the standard of care.\n     * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.\n\nExclusion Criteria:\n\n* Unable to provide written informed consent",{"count":474,"type":22},80,"24 Months","Development and validation of an integrated testing strategy for simultaneous detection of ESR-1 and gBRCA mutations via liquid biopsy in HR+\u002FHER2- metastatic breast cancer (mBC) patients, and the creation of a digital gene library to support an evidence-based diagnostic algorithm",[157],[479],"HR+\u002FHER2- BRCA","2026-03-23",{"date":482,"type":42},"2026-03-24",{"date":484,"type":42},"2024-12-20",{"date":486,"type":22},"2030-12-31",{"name":488,"class":49},"European Institute of Oncology",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":503,"locationsCount":50},"100570386","pik3ca-mutational-status-assessment-100570386","NCT06706570","PIK3CA Mutational Status Assessment","PIK3CA Mutational Status Assessment: Towards a \"Tailored\" Diagnostic Approach","Inclusion Criteria:\n\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of ER+ and\u002For PgR+ breast cancer by local laboratory.\n* Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.\n* Participants should be at advanced or metastatic setting prior to treatment.\n* Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.\n* Patients must be accessible for follow-up.\n\nExclusion Criteria:\n\n• patients already treated with different treatments like chemotherapy, hormone therapy etc",{"count":123,"type":22},"Evaluation of PIK3CA mutational status: a route towards a tailored diagnostic approach.",[34],{"date":482,"type":42},{"date":501,"type":42},"2024-11-06",{"date":486,"type":22},{"name":488,"class":49},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":61,"phases":514,"briefSummary":515,"conditions":516,"keywords":519,"overallStatus":163,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":50},"100630780","phase-2-screening-for-brain-metastases-100630780","NCT07492121","Screening for Brain Metastases","Quality and Safety of Screening for Brain Metastases by Gadopiclenol in Patients With Cancer at High Risk of Developing Brain Metastases","GAPIMET","Inclusion Criteria:\n\n1. Patients with histologically confirmed HER-2 positive or triple negative breast cancer, non-small cell lung cancer, or melanoma\n2. Up to 3 months after diagnosis of a cancer at high risk of CNS metastasis with indication for screening and follow-up by MRI (based on a high risk of CNS metastases according to EANO ESMO brain metastases guidelines: stage IV HER-2 positive or triple negative breast, stage II to IV lung cancer, stage IV melanoma)\n3. Enrolment at the time of initiation of screening and follow-up MRI: usually, but not necessarily at the time of new diagnosed stage IV HER-2 positive or triple negative breast, lung cancer, melanoma\n4. 18 years or older on day of signing informed consent\n5. Karnofsky performance status (KPS) ≥ 60\n6. Patients must have preserved renal function (serum creatinine \\\u003C 1.5 x ULN or creatinine clearance (CrCl) \\> 30 mL\u002Fmin (using the Cockcroft-Gault formula)\n7. Women of child-bearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test before the MRI.\n8. Patients of childbearing \u002F reproductive potential must agree to use adequate birth control measures, as defined by the investigator, during the study period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n9. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.\n10. Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.\n\nExclusion Criteria:\n\n1. Any contraindication to MRI, including claustrophobia\n2. Known severe adverse drug reaction or contraindication to gadolinium-based contrast agents\n3. Acute or chronic renal insufficiency: grade III or more (eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m2) based on one eGFR assessment performed within one day the MRI prior to the first contrast agent injection.\n4. Heart failure: class III\u002FIV NYHA\n5. Severe liver disease\n6. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements\n7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n8. Women who are pregnant or who breast feeding",{"count":513,"type":22},180,[100],"The survival of patients with CNS metastases often remains limited to some months. CNS metastases are also associated with neurological decline and decrease of quality of life. An early identification of CNS metastases may potentially lead to more therapeutic options and prevent or delay the development of neurological symptoms and signs. Patients with cancer associated with a high risk of developing CNS metastasis will be enrolled in this trial. These patients are candidates for a screening brain MRI program in the routine management as recommended in current guidelines (Le Rhun et al. 2021) (Amaral et al. 2025, \"ESMO Living Guideline: Cutaneous Melanoma, v1.0 February 2025\").\n\nThe primary objective is to compare the time to CNS metastases diagnosis detected by MRI using different contrast agents (of gadopiclenol at a dose of 0.1 mmol\u002Fkg over current standard practice ) in patients with cancer considered at high risk of developing brain metastases.",[517,518,34],"Lung Cancer Stage IV","Melanoma Stage IV",[520],"screening MRI","2026-03-18",{"date":523,"type":42},"2026-03-25",{"date":525,"type":22},"2026-09",{"date":527,"type":22},"2030-01",{"name":529,"class":49},"University of Zurich",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":61,"phases":537,"briefSummary":538,"conditions":539,"keywords":540,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":50},"100622926","nutrition-awareness-among-women-with-non-metastatic-breast-cancer-100622926","NCT07389967","Nutrition Awareness Among Women With Non-Metastatic Breast Cancer","Inclusion Criteria:\n\n* Age \\>18 -Female\n* Diagnosis of non-metastatic breast cancer\n* Completion of primary treatment for breast cancer\n* No recurrence or metastasis; or no other cancer other than basal or squamous cell\n* Willingness to provide a private email address for all study activities\n* Ability to read and understand English\n\nExclusion Criteria:\n\n* Inability to comply with one or more of the inclusion criteria",{"count":153,"type":22},[125],"This study explores perspectives of women with non-metastatic breast cancer regarding their willingness and ability to make dietary changes pertaining to foods\u002Ffood products that may pose a risk to their cancer prognosis and survival.\n\nThis is a single-group study conducted entirely online. All study activities, including consent, educational brochure and surveys, will be completed remotely. Participants will receive email invitations to complete questionnaires in REDCap.\n\nQuestionnaire 1 will collect sociodemographic information (no PHI) and a brief dietary recall.\n\nQuestionnaire 2 will assess identification of ultra-processed foods. Before Questionnaire 3, participants will review a two-page educational flyer explaining the link between diet, obesity, and cancer, with information on unhealthy calories and food processing.\n\nQuestionnaire 3 will assess participants' willingness and ability to eat healthier foods and reduce unhealthy foods.\n\nAt study completion, participants will receive a thank-you message and a brief satisfaction survey.",[36,34],[541,542],"nutrition","diet","2026-01-28",{"date":545,"type":42},"2026-02-05",{"date":547,"type":42},"2026-01-20",{"date":549,"type":22},"2027-01",{"name":551,"class":49},"UNC Lineberger Comprehensive Cancer Center",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":61,"phases":562,"briefSummary":563,"conditions":564,"keywords":581,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":612,"locationsCount":614},"100374021","phase-1-sharon-a-clinical-trial-for-metastatic-cancer-using-chemotherapy-and-patients-own-stem-cells-100374021","NCT04150042","SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells","SHARON: Study of Metastatic Cancers in Patients Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives","SHARON","Inclusion Criteria\n\n* Age ≥ 18 years.\n* Pancreatic or breast cancer, as described below.\n* Stage IV (based on AJCC staging guidelines) at the time of enrollment.\n\n  a. Note that potential subjects with stage IV cancer that have had a complete response from prior chemotherapy are still potentially eligible.\n* Expected survival time ≥ 6 months, as determined by the investigator.\n* Life expectancy not severely limited by diseases other than malignancy, as determined by the investigator.\n* Karnofsky score ≥ 60%.\n* No chemotherapy within 2 weeks of enrollment.\n* Prior surgical resection or ablation of the primary tumor is allowed but not required.\n* If post-surgical, the subject must be at least 28 days post-op with the surgical wounds healed and significant complications resolved.\n* Potential subjects who have received previous chemotherapy and\u002For PARP inhibitors may be enrolled.\n* Measurable or non-measurable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1.\n* For potential subjects with a germline BRCA1, BRCA2, or PALB2 mutation:\n\n  a. The mutation must be known to be deleterious or suspected to cause functional impairment as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.\n* For potential subjects with somatic BRCA1, BRCA2, or PALB2 mutations:\n\n  1. The mutation must be a known or suspected deleterious mutation as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.\n  2. There must be biallelic loss or inactivation of the mutated BRCA1, BRCA2, or PALB2 gene as assessed by a CLIA-certified laboratory.\n  3. The Genetics Review Committee for this trial, which is comprised of a core group of investigators and whose actions are performed in accordance with the committee's charter, must agree that the biallelic mutations are deleterious or suspected deleterious.\n* For subjects without a BRCA1, BRCA2, or PALB2 mutation\n\n  1. Subject must have received at least 16 weeks of first-line (platinum-based\\*) chemotherapy with no evidence of treatment failure, where treatment failure is defined as growing tumors, new lesions, or a steadily rising tumor marker during or within eight weeks of completion of the first line therapy.\n  2. \\* Subjects can also have been treated with FOLFIRINOX but switched to FOLFIRI due to oxaliplatin side effects.\n* For potential subjects with pancreatic cancer:\n\n  1. Pancreatic ductal adenocarcinoma or pancreatic acinar cell carcinoma.\n  2. If the potential subject has had surgical resection of the primary tumor, then there must be no evidence of disease progression between the time of surgical resection of the primary tumor and screening for enrollment if the patient is seeking enrollment in the immediate post-surgery period.\n* For potential subjects with breast cancer:\n\n  1. Adenocarcinoma of the breast.\n  2. HER2-negative cancer as per American Society of Clinical Oncology\u002FCollege of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guidelines.\n  3. Male or female sex.\n* Histological or cytological confirmation of the primary cancer diagnosis is required.\n* Metastatic disease must be histologically or cytologically confirmed unless in the clinical judgment of the investigator a biopsy is not needed for diagnostic purposes.\n* Female participants of childbearing potential must agree to do one of the following from the time of signing of the informed consent through 6 months after the last dose of melphalan:\n\n  1. Simultaneously practice two effective barrier methods of contraception. Oral and injectable contraceptives are not allowed. Barrier methods of birth control (e.g., diaphragm and spermicide, or condom and spermicide) are required.\n  2. Practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal) are not acceptable methods of contraception.\n* Male participants:\n\n  1. Unless the male is in a monogamous relationship with a female that does not have child-bearing potential, male subjects (even if surgically sterilized) must agree to do one of the following from the time of signing of the informed consent through 6 months after the last dose of melphalan:\n\n     1. Practice effective barrier contraception, plus a second method of effective contraception.\n     2. Practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal) are not acceptable methods of contraception.\n\nExclusion Criteria\n\n* Rapid disease progression or clinical features concerning for onset of rapid symptomatic deterioration, as determined by the investigator.\n* Biliary tract obstruction.\n* Current cholangitis. A biliary stent in situ does not otherwise exclude protocol participation.\n* A history of only one episode of cholangitis and fewer than 30 days have passed since discontinuation of antibiotic treatment.\n* A history of multiple episodes of cholangitis and after discussion between the site study team and sponsor medical monitor and careful evaluation for suitability the patient is deemed to be unsuitable for the trial due to risk of recurring cholangitis.\n* Portal hypertension.\n* Sinistral portal hypertension.\n* Obliteration or significant obstruction of the major veins or arteries (e.g., portal vein, superior mesenteric artery, superior mesenteric vein).\n* Clinically significant malignant ascites or malignant pleural effusion, as determined by the investigator.\n* Metastatic lesion to the heart or eye.\n* Chemotherapy for an indication other than treatment of the current cancer within the past 1 year with a more than 30% risk of recurrence as determined by the investigator.\n* Known or suspected metastatic involvement of the central nervous system.\n* Left ventricular ejection fraction less than 45% by Multigated Acquisition Scan or echocardiogram (or significantly below the lower limit of normal for the specific test).\n* Clinically significant structural heart disease or vascular disease.\n* Myocardial infarction within 6 months prior to enrollment; New York Heart Association (NYHA) Class III or IV heart failure; angina; uncontrolled ventricular arrhythmias; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.\n* Clinically significant prolongation of QTc (Bazett formula) on EKG, defined as \\> 0.45 s in males and \\> 0.47 s in females.\n* Severe hypertension, which is defined as the presence of any of the following:\n\n  1. History of hypertensive crisis, hypertensive emergency, or malignant hypertension within the last year.\n  2. Sustained or persistent systolic BP \\> 165 mm Hg or diastolic \\> 110 mm Hg.\n* Other clinically significant cardiovascular disease.\n* NOTE:\n\n  1. A past history of severe hypertension that is well-controlled with therapy or that was addressed by removal of the cause (e.g., removal of a medicine that caused the severe hypertension) is not an exclusion criterion.\n  2. The presence of a pacemaker is not a contraindication and is not considered an exclusion criterion\n* History or evidence of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis).\n* If a smoker, refusal to stop smoking for the duration of the trial.\n* FEV1 or DLCO (adjusted for hemoglobin) \\\u003C 50% of predicted.\n* Total bilirubin \\> 2x upper normal limit, except that potential subjects with Gilbert's Disease are permitted to exceed 2x upper normal limit.\n* ALT or AST \\> 2.5x upper normal limit.\n* Alkaline phosphatase \\> 2.5x upper normal limit, in conjunction with elevated GGT.\n* Albumin \\\u003C 3.0 g\u002Fdl.\n* Clinical evidence of sinusoidal obstruction syndrome.\n* Corrected creatinine clearance consistently \\\u003C 50 ml\u002Fmin\u002F1.73 m\\^2.\n* Clinically significant renal disease.\n* Hemolytic anemia.\n* Family history of catalase deficiency or history or evidence of a severe adverse reaction to hydrogen peroxide consistent with catalase deficiency, unless testing has demonstrated that the patient is not catalase-deficient.\n* Evidence of bone marrow insufficiency or failure, in the judgment of the investigator.\n* A hemoglobin \\\u003C 9 g\u002FdL.\n* G6PD deficiency as measured by quantitative enzyme levels below the normal reference range in blood.\n* Pre-existing bleeding diathesis or coagulopathy.\n* Potential subject is pregnant.\n* Breast feeding and unwilling to stop.\n* Wilson's disease.\n* Primary or secondary hemochromatosis.\n* Hgb A1c \\> 9%.\n* Hyperuricemia that is not responsive to therapy.\n* Plasma oxalate greater than 10 µM, which is not responsive to measures to reduce the level below 10 µM.\n* History of clinically significant elevation of plasma oxalic acid or complications related to oxalic acid.\n* Prior or current hepatitis B or C.\n* HIV infection or seropositivity for HIV.\n* Active, clinically significant bacterial, viral, or fungal infection.\n* History of colonization with a multidrug-resistant \"superbug\" that poses a high risk of an untreatable infection in the setting of neutropenia.\n* Uncontrolled seizure disorder.\n* If a potential subject has received radiation, then any of the following:\n\n  1. A volume ≥ 700 ml of normal liver received a dose ≥ 10 Gy.\n  2. The mean dose to normal liver (i.e., liver minus gross tumor volume) was ≥ 10 Gy.\n  3. The mean dose to normal lung (i.e., lung minus gross tumor volume) was ≥ 4 Gy.\n* History of significant allergy or other contraindication to BCNU, melphalan, vitamin B12b, vitamin C, pegfilgrastim, or Neupogen, or to any excipient in those drugs.\n* Use of any of the following cytochrome P450 2b6 (CYP2b6) inducers within 21 days of the planned date of BCNU treatment: phenobarbital, carbamazepam, rifampicin, phenytoin, sulfinpyrazone, or verapamil.\n* Disulfiram (Antabuse) use within 30 days of the planned ethanol administration.\n* Current chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine, corticosteroids).\n* Prior bone marrow stem cell transplant.\n* Except for adjuvant therapy for breast cancer or pancreatic cancer, prior radiation therapy to the brain, kidneys, pelvis, or GI tract or treatment with yttrium-90.\n* Prior treatment with bleomycin or BCNU.\n* Prior treatment, within 30 days of enrollment, with a drug that has not been FDA-approved for any indication (cancer or otherwise).\n* Subject has not fully recovered (i.e., there remain toxicities \\> Grade 1) from the reversible effects of prior chemotherapy, with the exception of chemotherapy-induced alopecia and grade 2 peripheral neuropathy, unless in the opinion of the principal investigator the effects are not of clinical significance.\n* Any concurrent anticancer treatment.\n* Serious underlying medical or psychiatric illness or another condition that in the clinical judgment of the principal investigator is likely to interfere with the potential subject completing participation in the trial, based on safety concerns or otherwise.\n* Inability or unwillingness to adhere to the study protocol.\n* Unwillingness to receive ethanol.",{"count":561,"type":22},24,[63],"The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitamin C with autologous hematopoietic stem cell infusion. A dose-escalation schedule is being employed for the vitamin C.",[565,566,567,568,569,570,571,572,34,226,573,227,228,574,575,576,577,578,579,580],"Pancreatic Adenocarcinoma Metastatic","BRCA1 Mutation","BRCA2 Mutation","Pancreatic Acinar Cell Carcinoma","Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer","Metastatic Pancreatic Cancer","Metastatic Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer Stage IV","Adenocarcinoma of the Breast","PALB2 Gene Mutation","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Pancreas Cancer","Stage IV Pancreatic Cancer","Stage 4 Pancreatic Cancer",[582,583,584,585,586,587,588,589,590,591,592,593,594,595,596,597,188,598,599,600,601,602,603,337,604,605],"pancreatic adenocarcinoma","pancreatic cancer","BRCA","BRCA1","BRCA2","melphalan","BCNU","carmustine","vitamin C","vitamin B12b","autologous stem cell infusion","stage 4 pancreatic cancer","metastatic pancreatic cancer","pancreatic acinar cell carcinoma","pancreatic ductal adenocarcinoma","PDAC","stage 4 breast cancer","stage IV pancreatic cancer","stage IV breast cancer","stem cells","HER2-negative breast cancer","PALB2","BRCA pancreatic cancer","BRCA breast cancer","2026-01-27",{"date":608,"type":42},"2026-01-29",{"date":610,"type":42},"2021-01-13",{"date":208,"type":22},{"name":613,"class":88},"General Oncology, Inc.",2,{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":622,"enrollmentInfo":623,"targetDuration":4,"studyType":61,"phases":624,"briefSummary":625,"conditions":626,"keywords":628,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":50},"100571098","phase-1-target-specific-immunopet-imaging-of-breast-cancer-100571098","NCT06715826","Target-specific immunoPET Imaging of Breast Cancer","Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer","Inclusion Criteria:\n\n1. Aged 18-75 years old and of female gender；\n2. Histologically confirmed diagnosis of breast cancer or suspected breast cancer by diagnostic imaging;\n3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.\n\nExclusion Criteria:\n\n1. Pregnancy；\n2. Severe hepatic and renal insufficiency;\n3. History of serious surgery in the last month;\n4. Allergic to antibody or single-domain antibody radiopharmaceuticals.","75 Years",{"count":153,"type":22},[63,100],"The aim of this study is to establish and optimize the Trop2\u002FHER2-targeted PET\u002FCT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in breast cancer will be evaluated.",[36,627,34],"Breast Neoplasms",[629,418,36,630],"Trop2","ImmunoPET","2026-01-25",{"date":606,"type":42},{"date":634,"type":42},"2024-09-21",{"date":636,"type":22},"2026-11",{"name":638,"class":49},"RenJi Hospital",{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":61,"phases":649,"briefSummary":650,"conditions":651,"keywords":656,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":665,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":673},"100615404","phase-1-a-phase-1b2-study-of-the-safety-and-efficacy-of-the-monoclonal-antibody-om-rca-01-in-patients-with-metastatic-tumors-expressing-fibroblast-growth-factor-receptor-1-100615404","NCT07292168","A Phase 1b\u002F2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1","A Phase 1b\u002F2 Study Evaluating the Safety and Preliminary Efficacy of OM-RCA-01, an Anti-FGFR1 Monoclonal Antibody, in Patients With Metastatic Cancers Expressing FGFR1.","TAGNOT","Inclusion Criteria:\n\n1. Signed and dated Informed Consent Form confirming voluntary participation in the study.\n2. Age ≥ 18 years at the time of consent.\n3. Body weight ≥ 50 kg.\n4. Histologically confirmed metastatic solid tumors:\n\n   1. clear-cell renal cell carcinoma;\n   2. non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations);\n   3. prostate cancer (castration-resistant adenocarcinoma);\n   4. breast cancer (adenocarcinoma with specified status for estrogen receptors, progesterone receptors, HER2);\n   5. head and neck tumors (squamous carcinoma, salivary gland cancer).\n5. Immunohistochemical expression of FGFR1 of 2+ or higher.\n6. Documented disease progression after at least two lines of standard therapy, or lack of available or feasible alternative standard treatment options for any reason.\n7. Presence of at least one measurable lesion according to RECIST 1.1 criteria.\n8. Availability of formalin-fixed and paraffin-embedded tumor tissue samples for biomarker analysis.\n9. ECOG performance status 0 or 1.\n10. Adequate organ function, confirmed by laboratory test results obtained within 7 days prior to Cycle 1 Day 1, meeting the following parameters:\n\n    * Hemoglobin level ≥ 90 g\u002FL\n    * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n    * Platelet count ≥ 100 × 10⁹\u002FL\n    * Serum creatinine level ≤ 1.5 × upper limit of normal (ULN)\n    * Glomerular Filtration Rate (GFR) ≥ 30 mL\u002Fmin\n    * AST and ALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases)\n    * Serum phosphorus within normal limits (≥ lower limit of normal and ≤ upper limit of normal)\n    * Serum calcium ≥ lower limit of normal\n    * Serum potassium ≥ lower limit of normal (note: use of medications to increase potassium during screening is permitted)\n11. Life expectancy of more than 12 weeks.\n12. Absence of any psychological, familial, social or geographical circumstances that could potentially serve as an obstacle to the fulfillment of the study protocol and follow-up procedures according to the prescribed schedule and the ability of the study participant to follow the requirements of the protocol; these circumstances should be discussed with the patient before inclusion in the study.\n13. Women capable of childbearing must be using an effective method of contraception.\n\nExclusion Criteria:\n\n1. Participation in another clinical trial or concomitant treatment with any investigational drug, or administration of any investigational anticancer therapy within 28 days prior to inclusion in this study.\n2. Presence of central nervous system (CNS) metastases and\u002For medullary carcinomatosis at the time of inclusion.\n\n   Exception: Patients with CNS metastases who have received therapy may participate if they have been clinically stable for at least 1 month prior to enrollment, defined by:\n   * No evidence of new or progressive CNS metastases\n   * No ongoing steroid therapy\n   * Stable mental status sufficient to provide informed consent\n3. History of or current evidence of any condition, therapy, or laboratory abnormality that could:\n\n   * Limit interpretation of study results,\n   * Prevent completion of the study protocol, or\n   * Pose a risk to patient safety or well-being. This includes any serious or unstable general medical, psychiatric, or other conditions potentially jeopardizing safety, informed consent, or compliance.\n4. Any second malignancy within the previous 5 years, except for adequately treated cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma of the skin with limited growth, provided these are well controlled.\n5. Known regular use of illicit substances or recreational drugs, or a history of drug abuse or alcoholism within the past year.\n6. Plans to conceive during the study period, current pregnancy, or lactation.\n7. Known HIV-positive status.\n8. Known active hepatitis B or C infection.\n9. Evidence of active bleeding or hemorrhagic diathesis.\n10. Radiation therapy within 14 days prior to inclusion.\n11. Receipt of any anti-tumor treatments including:\n\n    * Surgery or tumor embolization within 14 days prior to the first OM-RCA-01 dose, or\n    * Chemotherapy, immunotherapy, biological therapy, investigational therapy, or endocrine therapy (except ongoing androgen deprivation therapy for prostate cancer) within 14 days or within two half-lives of the drug (whichever is longer) prior to the first OM-RCA-01 dose.\n12. Prior treatment with any FGFR-inhibiting or FGFR-blocking agents.",{"count":648,"type":22},58,[63,100],"One of the most relevant targets in the field of novel targeted anticancer therapy is the family of receptors to fibroblast growth factor receptors (FGFRs). FGFR1 is the main representative of the FGFR family.\n\nThe goal of this clinical trial is to learn if monoclonal anti-FGFR1 antibody (OM-RCA-01) works to treat metastatic cancers expressing FGFR1. It will also learn about the safety of drug OM-RCA-01. The main questions it aims to answer are:\n\n1. What medical problems do participants have when receiving drug OM-RCA-01?\n2. What dose of the drug should patients receive in the next studies?\n3. Does tumor growth slow down in patients receiving OM-RCA-01?\n\nAll patients in this study will receive the antibody treatment. The drug will be given through a vein (by IV infusion) every two weeks, for as long as the disease remains under control and the treatment is well tolerated.",[652,653,654,34,655],"Renal Cell Carcinoma Metastatic","Prostate Cancer Metastatic","Non-small Cell Lung Cancer Metastatic","Head & Neck Cancer",[77,657,658,659,660,661,662,663,664,188],"resistance","monoclonal antibody","fibroblast growth factor receptor 1","OM-RCA-01","kidney cancer","prostate cancer","head & neck cancer","lung cancer",{"date":666,"type":42},"2026-01-21",{"date":668,"type":42},"2025-12-02",{"date":670,"type":22},"2027-01-01",{"name":672,"class":49},"Kidney Cancer Research Bureau",5,{"id":675,"slug":676,"hasResults":12,"nctId":677,"briefTitle":678,"officialTitle":679,"acronym":4,"eligibilityCriteria":680,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":681,"targetDuration":4,"studyType":61,"phases":683,"briefSummary":684,"conditions":685,"keywords":690,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":697,"lastUpdatePostDateStruct":698,"startDateStruct":699,"completionDateStruct":701,"leadSponsor":702,"locationsCount":50},"100621352","phase-1-sapu003-in-advanced-mtor-sensitive-solid-tumors-100621352","NCT07369505","Sapu003 in Advanced mTOR-sensitive Solid Tumors","A Phase 1b, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Sapu003 in Advanced mTOR-sensitive Solid Tumors (With or Without Exemestane)","Inclusion Criteria:\n\n1. Sex and Age: Patients must be ≥ 18 years of age at the time of informed consent.\n\n   * Cohort A (HR+\u002FHER2- breast cancer): Eligible patients must be postmenopausal women, defined as women ≥ 18 years of age with amenorrhea for ≥ 12 consecutive months without another pathophysiological cause.\n   * Cohort B (RCC, NETs, TSC-associated tumors, HCC): Eligible patients include both male and female adults with advanced disease.\n2. Cohort A HR+\u002FHER2- Breast Cancer:\n\n   Eligible patients must meet all of the following:\n   * Has histologically or cytologically documented advanced (metastatic or unresectable) hormone receptor-positive, HER2 negative breast cancer (advanced HR+ BC)\n   * Has stage IV or locally advanced breast cancer per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, Seventh Edition;\n   * Has failed any combination endocrine therapy or relapse within 6 months of adjuvant chemotherapy for metastatic or locally advanced disease. Prior therapy should have included a non-steroidal aromatase inhibitor unless clinically contraindicated;\n   * Has agreed to participate in the study and signed the informed consent form prior to participation in any study activities.\n3. Cohort B Other Advanced mTOR-Sensitive Solid Tumors:\n\n   Eligible patients must meet all of the following:\n   * Has histologically or cytologically confirmed advanced (metastatic or unresectable) disease in one of the following tumor types:\n\n     * Renal Cell Carcinoma (RCC)\n     * Neuroendocrine Tumors (NETs)\n     * Tuberous Sclerosis Complex (TSC)-associated tumors\n     * Hepatocellular Carcinoma (HCC)\n   * Has disease that is measurable and\u002For evaluable per RECIST v1.1 (or relevant criteria, if applicable).\n   * Has progressed on or is intolerant to at least one prior line of standard therapy appropriate for the specific tumor type, unless no effective standard therapy exists.\n   * Has agreed to participate in the study and signed the informed consent form prior to participation in any study activities.\n4. Patients must be on stable doses of metformin or statin\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n6. Life expectancy ≥ 3 months\n7. Hematology\u002Fchemistry: Patient has adequate hematological, renal, and hepatic function as defined by the following Screening laboratory values obtained within 7 days prior to randomization and assessed based on local labs (patients should not have received a transfusion within 7 days before the Screening laboratory assessments):\n\n   * Absolute neutrophil count (ANC) ≥ 2,000 cells\u002Fmm3 (2 x109\u002FL)\n   * Platelet count ≥ 100,000 cells\u002Fmm3 (100x109\u002FL)\n   * Hemoglobin≥ 9 g\u002FdL\n   * Serum creatinine≤ 1.5 x the upper limit of normal (ULN)\n   * Total bilirubin ≤1.5 x ULN or direct bilirubin ≤1 x ULN for patients with total bilirubin levels \\> 1.5 ULN\n   * AST (SGOT) \u002F ALT (SGPT) ≤ 2.5 x ULN (≤5 x ULN for patients with metastases.)\n   * GFR ≥ 50 mL\u002Fmin\u002F1.73m2 by the CKD-EPI or MDRD formulas.\n8. All other clinical laboratory values deemed as normal or not clinically significant by the Principal Investigator\u002FSub-Investigator.\n9. Breastfeeding: Patients must be non-lactating. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding must be discontinued prior to the first dose of study drug.\n10. Female patients of reproductive potential to avoid becoming pregnant and to use effective contraception during the study and for 8 weeks after the last dose. Male patients with female partners of reproductive potential to use effective contraception during the study and for 4 weeks after the last dose.\n11. Able and willing to adhere to all protocol requirements and study procedures throughout the course of the study.\n12. Ability to comprehend and be informed of the nature of the study, as assessed by study clinic staff\n\nExclusion Criteria:\n\n1. Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix, curatively treated in-situ carcinoma of the breast, or other solid tumors curatively treated with no evidence of disease for \\> 5 years.\n2. Patients who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, target therapy, or radiotherapies ≥ Grade 1 per NCI CTCAE version 5.0, with the exception of alopecia.\n3. Patients who have received any of the following treatments within the specified timeframes prior to screening:\n\n   * Prior chemotherapy within 30 days prior to screening (42 days for mitomycin C or nitrosoureas).\n   * Prior immunotherapy, prior anti-tumor hormonal therapy (for breast cancer patients), and prior radiotherapy within 30 days prior to screening.\n   * Radiotherapy is not allowed during study. Administration of other chemotherapy, immunotherapy, or anti-tumor hormonal therapy during the study is not allowed.\n4. Patients had major surgery within 30 days prior to randomization, or patients have not recovered from prior major surgery.\n5. Sensory \u002F Peripheral neuropathy of \\> Grade 1 per NCI CTCAE version 5.0 at Screening.\n6. Patients with active brain metastases. Patients with treated brain metastases are eligible provided they have no evidence of active brain disease and are off of definitive therapy (including steroids) at least 3 months prior to randomization.\n7. Known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Principal Investigator\u002FSub-Investigator. This includes, but is not limited to, the following: hepatic, renal\u002Fgenitourinary, gastrointestinal (e.g., intra-abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina pectoris), cerebrovascular, pulmonary (e.g., interstitial lung disease), endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological, or hematological (e.g., bleeding diathesis or coagulopathy).\n8. History of difficulty with donating blood or difficulty in accessibility of central line.\n9. Known history or presence of:\n\n   * Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C (serology to confirm absence is required within 7 days prior to randomization and assessed based on local labs);\n   * Alcohol abuse or dependence within one year prior to randomization;\n   * Drug abuse or dependence (marijuana, amphetamines, barbiturates, cocaine, opiates and benzodiazepines);\n   * Hypersensitivity or idiosyncratic reaction to everolimus, other rapamycin derivatives or its excipients\n   * Severe allergic reactions (e.g., anaphylactic reactions, angioedema).\n10. Patients may not participate in any other clinical protocol or investigational trial that involves administration of experimental therapy and\u002For the use of investigational devices with therapeutic intent within 30 days prior to randomization and while enrolled in this study. Caution is recommended when administering Sapu003 and concomitantly with known substrates, PgP inhibitors, inhibitors, and inducers of the cytochrome P450 isoenzymes CYP2C8 and CYP3A4.\n11. Use of any strong inhibitors of cytochrome P450 (CYP) enzymes (e.g., fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (e.g., barbiturates (phenobarbital), carbamazepine, phenytoin and rifampin), in the previous 14 days before randomization until the last blood draw in the study.\n12. Acute active infection requiring antibiotics, antiviral agents, or antifungal agents within 14 days prior to randomization\n13. Pregnant or lactating women.",{"count":682,"type":22},27,[63],"This is a phase 1b, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics of Sapu003 in combination with Exemestane in in patients with advanced mTOR-sensitive solid tumors (HR+\u002FHER2-negative breast cancer, renal cell carcinoma \\[RCC\\], neuroendocrine tumors \\[NETs\\], tuberous sclerosis complex \\[TSC\\]-associated tumors, and hepatocellular carcinoma \\[HCC\\]).",[34,686,687,688,689],"Renal Cell Carcinoma (RCC)","Neuroendocrine Tumors","Tuberous Sclerosis Complex (TSC)","Hepatocellular Carcinoma (HCC)",[691,692,693,686,694,688,689,695,696],"Sapu003","Everolimus for Injection","mTOR-Sensitive Solid Tumors","Neuroendocrine Tumors (NETs)","everolimus","HR+\u002FHER2-negative breast cancer","2026-01-17",{"date":606,"type":42},{"date":700,"type":42},"2025-12-15",{"date":319,"type":22},{"name":703,"class":88},"SAPU NANO (US) LLC",{"id":705,"slug":706,"hasResults":12,"nctId":707,"briefTitle":708,"officialTitle":709,"acronym":710,"eligibilityCriteria":711,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":622,"enrollmentInfo":712,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":713,"conditions":714,"keywords":715,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":717,"lastUpdatePostDateStruct":718,"startDateStruct":720,"completionDateStruct":722,"leadSponsor":724,"locationsCount":50},"100576409","to-investigate-the-real-world-efficacy-and-safety-of-sacituzumab-govitecan-for-her2-negative-metastatic-breast-cancer-patients-in-china-100576409","NCT06784921","To Investigate the Real-world Efficacy and Safety of Sacituzumab Govitecan for HER2 Negative Metastatic Breast Cancer Patients in China.","Real-World Patient Characteristics, Treatment Patterns, and Outcomes for Patients With HER2 Negative Metastatic Breast Cancer Treated With Sacituzumab Govitecan: A Retrospective Trial in China（SACIT-OUT）","SACIT-OUT","Inclusion Criteria:\n\nLocal recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.\n\nHER2-negative breast cancer(according to 2018 ASCO\u002FCAP HER2 test guideline). 18-75 years old. ECOG PS 0～2. life expectancy is not less than 12 weeks. at least one measurable lesion according to RECIST 1.1. received at least two cycles of SG. Signed informed\n\nExclusion Criteria:\n\nPatients who did not receive sacituzumab govitecan treatment for two or more cycles Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.\n\nFemale patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial History of neurological or psychiatric disorders Researchers believe that patients are not suitable for any other situation in this study.",{"count":153,"type":22},"To investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.",[34],[421,716],"Sacituzumab Govitecan","2026-01-14",{"date":719,"type":42},"2026-01-16",{"date":721,"type":42},"2025-02-01",{"date":723,"type":22},"2026-12-30",{"name":725,"class":49},"Zhejiang Cancer Hospital",{"id":727,"slug":728,"hasResults":12,"nctId":729,"briefTitle":730,"officialTitle":731,"acronym":4,"eligibilityCriteria":732,"healthyVolunteers":12,"sex":58,"minAge":733,"maxAge":4,"enrollmentInfo":734,"targetDuration":4,"studyType":61,"phases":736,"briefSummary":737,"conditions":738,"keywords":4,"overallStatus":163,"whyStopped":4,"lastUpdateSubmitDate":739,"lastUpdatePostDateStruct":740,"startDateStruct":742,"completionDateStruct":744,"leadSponsor":746,"locationsCount":4},"100581410","phase-2-fulvestrant-with-ribociclib-versus-physicians-choice-treatments-recurred-after-completion-of-adjuvant-cyclin-dependent-kinase-46-inhibitors-in-hr-her2--metastatic-breast-cancer-100581410","NCT06849947","Fulvestrant With Ribociclib Versus Physician's Choice Treatments Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4\u002F6 Inhibitors in HR+, HER2- Metastatic Breast Cancer","Randomized Phase II Trial of Fulvestrant With Ribociclib Versus Physician's Choice Treatments for the Patients Who Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4\u002F6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as First Line Treatment (CLEE011AKR06R)","Inclusion Criteria:\n\n1. Participants must be at least 19 years of age at the time of signing the informed consent.\n2. Patient has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.\n3. Patient has HR-positive\u002FHER2-negative invasive breast cancer (based on most recently analyzed biopsy)\n\n   1. HER2 status is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing, according to ASCO\u002FCAP guidelines for HER2 testing (Wolff et al. 2018).\n   2. HR status is defined as positive in ER expression by IHC, according to the relevant ASCO\u002FCAP Guidelines (Allison et al. 2020)\n4. Patient must have received either at least 1 year of adjuvant abemaciclib or ribociclib.\n5. Recurrence of advanced breast cancer was diagnosed ≥1 year from the last dose of adjuvant CDK4\u002F6 inhibitor.\n6. Patients must have received a minimum of 2 years of adjuvant endocrine therapy (either alone or in combination with CDK4\u002F6 inhibitors)\n7. Patient has an ECOG PS 0 or 1.\n8. Must have at least one measurable lesion according to RECIST v1.1. Patients without measurable lesions must have at least one lytic bone lesion.\n9. Patient has adequate bone marrow and organ function as defined by the following laboratory values:\n\n   1. Absolute neutrophil count ≥ 1.5 × 109\u002FL\n   2. Platelets ≥ 100 × 109\u002FL\n   3. Hemoglobin ≥ 9.0 g\u002FdL\n   4. Serum creatinine \\\u003C 1.5 mg\u002FdL or CCr ≥ 50 mL\u002Fday\n   5. In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × upper limit of normal(ULN). If the patient has liver metastases, ALT and AST should be \\\u003C 5 × ULN\n   6. Total serum bilirubin \\\u003C ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin \\\u003C1.5 x ULN of the local laboratory in patients with well documented Gilbert's Syndrome\n10. Patient must be able to swallow study therapy\n11. Patient must be able to communicate with the investigator and comply with the requirements of the study procedures\n12. Patient must be willing to remain at the clinical site as required by the protocol.\n\nExclusion Criteria:\n\n1. Patients whose cancer recurs one year or later after completing adjuvant endocrine therapy\n2. Patients who have been free from endocrine therapy for at least 2 years\n3. Patient whose disease recurred during or within 1 year from adjuvant CDK4\u002F6 inhibitor treatment.\n4. Patient who did receive adjuvant palbociclib irrespective of disease-free interval.\n5. Patients who did not receive adjuvant CDK4\u002F6 inhibitor treatment or who received less than 1 year of adjuvant CDK4\u002F6 inhibitor treatment.\n6. Patients who have received fulvestrant in adjuvant setting before randomization.\n7. Patients who have received any line of systemic treatment for advanced breast cancer is not eligible.\n8. Participant has not recovered from clinical, and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1. Exception to this criterion: participants with grade 2 taxane-induced neuropathy, any grade of alopecia, amenorrhea or other toxicities not considered a safety risk for the participant as per investigator's discretion, are allowed to enter the study.\n9. Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.\n10. Patient with symptomatic, unstable CNS metastases. Note: Symptomatic CNS metastases should be locally treated prior enrollment.\n11. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n12. Patient has a known history of HIV infection (testing not mandatory).\n13. Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation in the clinical study (e.g., chronic pancreatitis, chronic active hepatitis, etc.).\n14. Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including but not limited to any of the following:\n\n    1. History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry\n    2. Documented cardiomyopathy\n    3. Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: ① Risk factors for Torsades de Pointe (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia ② Concomitant medication(s) with a known risk to prolong the QT interval and\u002For known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days prior to starting study drug) ③ Inability to determine the QTcF interval\n    4. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third-degree AV block)\n15. Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to Cycle 1 Day 1:\n\n    1. Concomitant medications, herbal supplements, and\u002For fruits (e.g., grapefruit, pummelos, star fruit, Seville oranges) and their juices that are strong inducers or inhibitors of CYP3A4\u002F5\n    2. Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4\u002F5.\n16. Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects of surgery.\n17. Patient who has received any investigational drug(s) within 14 days prior to first day treatment or within 5 half-lives of the investigational product (whichever is longer).\n18. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment.\n\n    Note: The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).\n19. Patient is concurrently using other antineoplastic agents (except for adjuvant endocrine treatment monotherapy)\n20. Patient who has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to randomization, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia) and\u002For if ≥ 25% of the bone marrow was irradiated.\n21. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.\n22. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and after stopping study medication.\\* Highly effective contraception methods include:\n\n    \\* Ribociclib : For at least 3 weeks after the last dose, Fulvestrant : For 2 years after the last dose, Everolimus : For up to 8 weeks after the last dose.\n\n    \\- Effective contraception must be used as follows.\n    1. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    2. Total hysterectomy (surgical removal of the uterus and cervix) or tubal ligation (getting your \"tubes tied\") at least six weeks before taking study treatment.\n    3. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.\n    4. Combination of the following: Barrier methods of contraception: Condom and intrauterine devices (IUDs) (e.g., loop insertion)\n23. Not able to understand and to comply with study instructions and requirements.","19 Years",{"count":735,"type":22},272,[100],"▪ Fulvestrant With Ribociclib versus Physician's choice treatments for the patients who recurred after completion of Adjuvant Cyclin-Dependent Kinase 4\u002F6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as first line treatment",[34],"2025-12-17",{"date":741,"type":42},"2025-12-24",{"date":743,"type":22},"2026-02-01",{"date":745,"type":22},"2031-12-31",{"name":747,"class":49},"Yeon Hee Park"]