[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,85,0,25,[9,50,82,118,139,174,200,223,243,274,298,330,356,379,402,423,450,469,493,522,547,568,593,619,637],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100641445","decision-support-tool-for-patients-with-advanced-breast-cancer-100641445",false,"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","ALL","18 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Breast Cancer Metastatic","Advanced Breast Cancer","Stage 4 Breast Cancer","Stage IV (Metastatic) Breast Cancer",[33,34,35,36],"Decision support tool","advanced breast cancer","communication","Treatment preferences","RECRUITING","2026-08-18",{"date":40,"type":41},"2026-08-19","ACTUAL",{"date":43,"type":41},"2026-06-17",{"date":45,"type":22},"2028-02",{"name":47,"class":48},"Weill Medical College of Cornell University","OTHER",3,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100545518","phase-3-elacestrant--everolimus-in-patients-erher2--esr1mut-advanced-breast-cancer-progressing-to-et-and-cdk46i-100545518","NCT06382948","Elacestrant + Everolimus in Patients ER+\u002FHER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4\u002F6i.","A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Elacestrant Plus Everolimus Versus Elacestrant in Patients With ER+\u002FHER2-, ESR1mut Advanced Breast Cancer Progressing to Endocrine Therapy and CDK4\u002F6 Inhibitors","ADELA","Inclusion Criteria:\n\nPatients will be included in the study only if they meet ALL of the following criteria:\n\n1. Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female or male patients ≥ 18 years of age at the time of signing ICF.\n3. Pre- or perimenopausal women, who do not meet the criteria for post-menopausal status (defined in continuation) and men must be concurrently receiving a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol\u002Ffollicle-stimulating hormone \\[FSH\\] must be confirmed analytically) prior to study randomization and are planning to continue LHRH agonist treatment during the study.\n\n   Post-menopausal women as defined by any of the following criteria:\n   1. Age ≥ 60 years;\n   2. Age \\\u003C 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and\u002For FSH levels within the laboratory's reference range for post-menopausal females;\n   3. Documented bilateral surgical oophorectomy.\n4. Histologically- or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either unresectable locally recurrent or metastatic disease confirmed by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.\n5. Documentation of ER\\[+\\] (≥10% positive stained cells) and HER2\\[-\\] (0-1+ by immunohistochemistry \\[IHC\\] or 2+ and negative by in situ hybridization \\[ISH\\] test) tumor according to the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines as per local assessment. ER\\[+\\]\u002FHER2\\[-\\] status should be confirmed in metastatic setting, with exception of patients with bone and lung only disease.\n6. Patients with ESR1 mutational status will be determined before patient randomization using Guardant360 CDx (Guardant Health) test.\n\n   Note: Patients with previously determined ESR1 mutation using appropriately validated tests (Guardant360 CDx \\[Guardant Health\\], FoundationOne CDx, FoundationOne Liquid \\[Foundation Medicine Inc\\]) will be eligible for inclusion. This local determination can be performed either in blood or tumor samples.\n7. Radiological or objective evidence of disease progression on prior treatment with a CDK4\u002F6 inhibitor in combination with endocrine therapy for advanced disease after at least 6 months of treatment. Patients receiving CDK4\u002F6 inhibitor-based therapy in the adjuvant setting are also eligible provided that disease progression is confirmed after at least 12 months of treatment but no more than 12 months following CDK4\u002F6 inhibitor treatment completion in this scenario.\n8. Patients must have previously received at least one and no more than two lines of endocrine therapy for ABC. Progression during or within 12 months of adjuvant endocrine therapy is considered as a line of endocrine therapy for advanced disease.\n9. No prior elacestrant or other investigational SERDs, proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), or novel SERM, and\u002For PI3K\u002FAKT\u002FmTOR inhibitors, including everolimus, for advanced disease are permitted.\n\n   Note: Fulvestrant is permitted if treatment was completed administered at least 28 days before randomization.\n10. No prior chemotherapy for advanced disease is allowed.\n11. Evidence of measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), or non-measurable, but evaluable, disease, including bone-only disease with at least one lytic or mixed lytic-blastic bone lesion.\n12. Willingness and ability to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue or block. If a newly obtained baseline biopsy of an accessible tumor lesion is not possible to be obtained prior randomization, an archival tissue sample will be accepted.\n13. Fasting serum cholesterol ≤ 300 mg\u002FdL or 7.75 mmol\u002FL and fasting triglycerides ≤ 2.5 times the upper limit of normal (x ULN).\n14. Adequate bone marrow and organ function:\n\n    1. Hematological (without platelet, red blood cell transfusion, and\u002For granulocyte colony-stimulating factor support within seven days before randomization): absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL; platelet count ≥ 100.0 x109\u002FL; and hemoglobin ≥ 9.0 g\u002FdL.\n    2. Hepatic: Serum albumin ≥ 2.5 g\u002FdL; total serum bilirubin \\\u003C 1.5 x ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN; alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 3 x ULN in patients with liver and\u002For bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 x ULN (≤ 3 x ULN in patients with liver metastases).\n    3. Renal: Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL\u002Fmin as calculated by Cockcroft- Gault equation.\n    4. Coagulation: International normalized ratio (INR) ≤ 1.5 x ULN, unless that the patient meets the exception described in the exclusion criteria 16.\n15. Resolution of all acute toxic effects of prior anti-cancer therapy to grade ≤ 1 as determined by the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 (except for toxicities not considered a safety risk for the patient at Investigator's discretion).\n\n    Note: Patients with grade 2 alopecia are allowed.\n16. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 7 days before randomization. In addition, they agree to use one highly effective method of birth control 28 days prior to start of treatment until 120 days after the last dose of study treatments. Female patients must refrain from egg cell donation and breastfeeding during this same time period.\n17. Male participants with a female partner of childbearing potential must be surgically sterile or using a highly effective method of contraception 28 days prior to treatment until 120 days after the last dose of study treatments to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period. Not engaging in heterosexual activity (sexual abstinence) for the duration of the study and 120 days after the last dose of study treatments is an acceptable practice if this is the preferred usual lifestyle of the participant.\n18. ECOG performance status of 0-1.\n19. Minimum life expectancy of ≥ 12 weeks at screening.\n\nExclusion Criteria:\n\nAny patient meeting ANY of the following criteria will be excluded from the study:\n\n1. Inability to comply with study and follow-up procedures.\n2. Formal contraindication to endocrine therapy defined as visceral crisis and\u002For rapidly or symptomatic progressive visceral disease.\n3. Current participation in another therapeutic clinical trial.\n4. Treatment with approved or investigational cancer therapy within 14 days prior to randomization except for fulvestrant that must be administered completed at least 28 days before randomization.\n5. Known active uncontrolled or symptomatic central nervous system (CNS) metastases and\u002For leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and\u002For progressive growth. Patients with a history of CNS metastases are eligible if they have been previously treated with local therapy, are clinically stable, and off anticonvulsants and steroids for at least 14 days before randomization.\n6. Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion).\n7. Concurrent malignancy or malignancy within three years before randomization with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.\n8. Known allergy or hypersensitivity reaction to any investigational medicinal products (IMPs) or their incorporated substances.\n9. History of malabsorption syndrome or other condition that would interfere with enteral absorption (ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass) or results in the inability or unwillingness to swallow pills.\n10. Palliative radiotherapy with a limited field of radiation within two weeks or with wide field of radiation or to more than 30% of the bone marrow within four weeks prior to randomization.\n11. Major surgical procedure or significant traumatic injury within 14 days before randomization or anticipation of need for major surgery within the course of the study treatment.\n12. Clinically relevant cardiovascular\u002Fcerebrovascular disease and\u002For cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following:\n\n    a. Symptomatic pericarditis, unstable angina pectoris, documented myocardial infarction, coronary\u002Fperipheral artery bypass graft, symptomatic cardiac heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II-IV), or cerebrovascular accident including transient ischemic attack within six months before study randomization.\n13. Concurrent uncontrolled atrial fibrillation, other ongoing cardiac dysrhythmias grade ≥ 2 as determined by NCI-CTCAE v.5.0, or prolonged QT Interval Corrected by Fridericia's formula (\\[QTcF\\] \\> 480 msec).\n14. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited, to any of the following:\n\n    1. Massive lung metastatic involvement (e.g., pleural effusion, lymphangitic carcinomatosis, etc.).\n    2. Any underlying pulmonary disorder (e.g., severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, post Coronavirus disease (COVID-19) pulmonary fibrosis, etc.).\n    3. Any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.).\n    4. Prior pneumonectomy.\n15. History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n16. Coagulopathy or any history of coagulopathy within six months before study enrollment, including history of deep vein thrombosis or pulmonary embolism. However, patients with the following conditions will be allowed to participate:\n\n    1. Adequately treated catheter-related venous thrombosis occurring more than 28 days prior to randomization.\n    2. Treatment with an anticoagulant (e.g., warfarin or heparin) for a thrombotic event occurring more than six months before randomization, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to randomization.\n17. Concomitant treatment with immunosuppressive agents or chronic corticosteroids use before randomization with the following exceptions: topical applications, inhaled sprays, eye drops, mouthwash, or local injections are allowed. Patients on stable low dose of corticosteroids ( ≤ 10 mg\u002Fday of prednisone or equivalent) for at least two weeks before randomization are also permitted.\n18. Unable or unwilling to avoid prescription medications, over-the-counter medications, dietary\u002Fherbal supplements (e.g., St. John's wort), and\u002For foods (e.g., grapefruit, pomelos, star fruit, Seville oranges and their juices) that are moderate\u002Fstrong inhibitors or inducers of CYP3A4 activity. Participation will be allowed if the medication, supplements, and\u002For foods are discontinued for at least five half-lives or 14 days (whichever is shorter) prior to randomization and for the duration of the study.\n19. Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol.\n20. Current known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. Any other active uncontrolled infection at the time of screening is not allowed.\n21. Known substance abuse or any other concurrent severe and\u002For uncontrolled psychiatric or medical condition that would, in the Investigator's judgment, contraindicate patient participation.",{"count":59,"type":22},300,[61],"PHASE3","This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive\u002Fhuman epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.\n\nThe main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive\u002FHER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival.\n\nRigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.",[29,64,65,66],"ER-positive Breast Cancer","HER2-negative Breast Cancer","ESR1 Gene Mutation",[68,69,70,71,72],"ER-positive","HER22-negative","ESR1-mutation","CDK4\u002F6-inhibitor","Selective endocrine receptor degrader (SERD)",{"date":74,"type":41},"2026-08-20",{"date":76,"type":41},"2024-12-05",{"date":78,"type":22},"2028-04",{"name":80,"class":48},"MedSIR",104,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":93,"conditions":94,"keywords":102,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":117},"100525326","phase-1-bgb-43395-alone-or-as-part-of-combination-therapies-in-participants-with-breast-cancer-and-other-advanced-solid-tumors-100525326","NCT06120283","BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors","A Phase 1a\u002F1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced\u002Fmetastatic disease including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4\u002F6 inhibitor. For combination with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Phase 1b: Participants with HR+\u002FHER2- breast cancer.\n* Phase 1b: For combination with fulvestrant, participants with HR+\u002FHER2- breast cancer enrolled in regions where CDK4\u002F6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced\u002Fmetastatic disease including endocrine therapy and a CDK4\u002F6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic treatment is prohibited. For combination cohorts with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n* Female participants with metastatic HR+\u002FHER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.\n* Adequate organ function without symptomatic visceral disease.\n\nExclusion Criteria:\n\n* Known leptomeningeal disease or uncontrolled, untreated brain metastases.\n* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n* Uncontrolled diabetes.\n* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.\n* Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU\u002FmL (or ≥ 2500 copies\u002FmL) at screening.\n* Participants with active hepatitis C infection.\n* Prior allogeneic stem cell transplantation, or organ transplantation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":90,"type":22},399,[92],"PHASE1","This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.",[95,29,96,97,98,99,65,100,101],"Advanced Solid Tumor","Metastatic Breast Cancer","Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Malignant Neoplasm of Breast","Hormone Receptor Positive HER-2 Negative Breast Cancer","Non-small Cell Lung Cancer",[103,104,34,105,106,100,107,108],"breast cancer","advanced solid tumor","hormone receptor positive breast cancer","HER2-negative breast cancer","BGB-43395","non-small cell lung cancer",{"date":40,"type":41},{"date":111,"type":41},"2023-12-01",{"date":113,"type":22},"2028-11",{"name":115,"class":116},"BeOne Medicines","INDUSTRY",62,{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":125,"minAge":19,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":136,"locationsCount":138},"100506567","capecitabine-and-cyclophosphamide-xc-as-maintenance-therapy-for-advanced-breast-cancer-100506567","NCT05876065","Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer","Efficacy and Safety of Capecitabine and Cyclophosphamide (XC) Versus Physician's Choice as Maintenance Therapy for Advanced Breast Cancer: a Randomized, Controlled, Open-label Clinical Trial","Inclusion Criteria:\n\n* Female, age≥18 years old\n* ECOG≤2\n* Pathologically confirmed primary breast cancer, with pathologically or radiologically confirmed recurrent or metastatic lesions\n* HR+\u002FHER2+ or HR-\u002FHER2+ or HR-\u002FHER2-\n* At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1\n* Disease control (complete response + partial response + stable disease) after salvage treatment\n* Expected survival ≥6 months\n* Adequate organ function\n\nExclusion Criteria:\n\n* during pregnancy and lactation\n* Patients with central nervous system metastasis","FEMALE",{"count":127,"type":22},86,[25],"To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.",[29],"2026-08-17",{"date":40,"type":41},{"date":134,"type":41},"2023-06-01",{"date":45,"type":22},{"name":137,"class":48},"Wenjin Yin",1,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":18,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":158,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":173},"100379579","phase-1-metarrestin-ml-246-in-subjects-with-metastatic-solid-tumors-100379579","NCT04222413","Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","* INCLUSION CRITERIA:\n* Adult (\\>= 18 years) subjects with:\n\n  * histologically or cytologically confirmed solid tumors (Phase IA).\n\nOR\n\n--histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB)\n\nOR\n\n* Pediatric (\\>=12 and \\\u003C 18 years) subjects with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell\u002Fsclerosing and pleomorphic subtypes of RMS (Phase IB).\n* Subjects must have disease that:\n\n  * is not amenable to potentially curative resection,\n  * spread at least to one other organ system other than primary tumor or recurred after removal of primary tumor\n  * has site measurable per RECIST 1.1 (Phase IB only).\n  * progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)\n  * have no standard therapy option available (Phase IB2)\n* Patients must have recovered from any acute toxicity related to prior therapy or surgery or disease to a grade 1 or less.\n* Performance status\n\n  * Karnofsky \\>= 70% (for patients \\>= 16 years old), Lansky \\>= 70% (for patients \\\u003C16 years old)\n* Adequate hematological function defined by:\n\n  * absolute neutrophil count (ANC) \\>= 1.0 x 10(9)\u002FL,\n  * transfusion-independent platelet count \\>= 100 x 10(9)\u002FL,\n  * Hgb \\>= 9 g\u002F dL (patients who have received \\\u003C= 2 PRBC transfusions within 48 hours are eligible)\n* Adequate coagulation as defined by:\n\n  --INR\\\u003C1.5 (or \\\u003C 3.0 if subjects are currently taking anticoagulated medications) Note: increase of the upper limit of INR is restricted only to subjects who are receiving anticoagulation for medical reasons (DVT\u002FPE prophylaxis, treatment for a thromboembolic event) and have increased INR because of these medications. Patients who have an elevated INR due to compromised liver function or any other medical conditions remain excluded\n* Adequate hepatic function defined by:\n\n  --a total bilirubin level \\\u003C= 1.5 x ULN, (total bilirubin \\\u003C= 2.0 x ULN in case of prior diagnosis of Gilbert syndrome)\n  * an AST level \\\u003C= 3xULN\n  * an ALT level \\\u003C= 3 xULN\n* Adequate renal function defined by:\n\n  --Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\\*\n\n  ---\\\u003C 1.5x institution upper limit of normal OR\n\n  ---\\>= 45 mL\u002Fmin\u002F1.73 m\\^2 for participant with creatinine levels \\>= 1.5 X institutional ULN\n\n  \\*Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n* The effects of the study treatment on the developing human fetus are unknown; thus, individuals of childbearing potential and individuals who can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior\n\nto study entry, for the duration of study therapy and up to 120 days after the last dose of the study drug.\n\n* Nursing participants must be willing to discontinue nursing at the time of the study treatment initiation.\n* Weight: \\>= 35 kg (\\>= 18 years old) or \\>=40 kg (\\>= 12 and \\\u003C 18 years old).\n* Ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document.\n* Subjects must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies (Cohort IB1 only).\n* Ability to swallow oral capsules.\n\nEXCLUSION CRITERIA:\n\n* Anticancer treatment within designated period before treatment initiation including:\n\n  * minor surgical procedure (such as biliary stenting) within 14 days. Note: if liver function tests after biliary stenting or renal function tests after ureteral stenting return to normal, within 5 days after biliary or ureteral stenting;\n  * major surgical procedure or curative radiation treatment within 28 days;\n  * palliative radiation treatment within 14 days;\n  * chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less within 14 days;\n  * experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days;\n  * chemotherapy regimen containing an alkylating antineoplastic agent (cyclophosphamide, chlorambucil, melphalan, or ifosfamide), alkylating-like (platinumbased chemotherapeutic drugs, platinum analogues), and non-classical alkylating agent (dacarbazine, temozolomide) within 28 days.\n* Patients receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4 and are not able to safely stop these medications are excluded from this study; patients must stop strong CYP3A4 inhibiting\u002Finducing medications within 5 published half-lives and moderate within 3 published half-lives prior to the treatment initiation.\n\nNote: dihydropyridine calcium - channel blockers are permitted for management of underling disease.\n\n* Subjects with cardiomyopathy diagnosed within 6 months prior to treatment initiation including but not limited to the following:\n\n  * hypertrophic cardiomyopathy\n  * arrhythmogenic right ventricular cardiomyopathy\n  * abnormal ejection fraction (echocardiogram \\[ECHO\\]) \\\u003C= 53% (if a range is given then the upper value of the range will be used)\n  * previous moderate or severe impairment of left ventricular systolic function (LVEF \\\u003C45%)\n  * severe valvular heart disease\n  * atrial fibrillation with a ventricular rate \\>100 bpm on EKG at rest\n  * Fridericia's corrected QT interval (QTcF) \\>= 480 msec (adults) or \\>= 460 msec (pediatric subjects, aged 12 to \\\u003C18 years) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.\n* HIV, HCV, HBV positive patients on antiviral drugs are excluded due to the absence of previous experience with concurrent use of antiviral medications and the investigational drug product to be evaluated in the current study and possible for adverse pharmacokinetic and\u002For pharmacodynamic interactions.\n* Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Note: subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded.\n* Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures.\n* Subjects with central nervous system (CNS) metastases or CNS disorders known to increase possible neurotoxicity of metarrestin in case of compromised blood-brain barrier (e.g. recent stroke (\\\u003C3 months of treatment initiation), infectious causes).\n* Significant acute or chronic infections including tuberculosis with presence of clinical symptoms or physical findings.\n* Patients with a history of any seizures or increased risk of seizures on screening EEGs defined by 1) interictal epileptiform discharges, 2) temporal intermittent rhythmic delta activity (TIRDA), or 3) electrographic or clinical seizures on EEG.\n* Clinically relevant diseases (for example, inflammatory bowel disease) and \u002F or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial.\n* Patients with previous gastric bypass, patients receiving nutrition via feeding tubes or parenterally, or patients with malabsorptive conditions (damage to the intestine from infection, inflammation, trauma, or surgery, celiac disease, Crohn's disease, chronic pancreatitis, or cystic fibrosis resulting malabsorption). Patients with refractory nausea and vomiting. Note: patients with gastric banding are allowed.\n* Pregnant individuals.","12 Years","120 Years",{"count":149,"type":22},116,[92],"Background:\n\nMetastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs.\n\nObjective:\n\nTo find a safe dose of metarrestin and to see if this dose shrinks tumors.\n\nEligibility:\n\nAdults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options.\n\nDesign:\n\nParticipants will be screened with:\n\n* blood tests\n* physical exam\n* documentation of disease confirmation or tumor biopsy\n* electrocardiogram to evaluate the heart\n* review of their medicines and their ability to do their normal activities\n\nParticipants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary.\n\nParticipants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body.\n\nAdult participants may have tumor biopsies.\n\nParticipants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.",[153,154,155,29,156,157],"Advanced Solid Tumors","Metastatic Pancreatic Cancer","Pediatric Solid Tumor","Malignant Peripheral Nerve Sheath Tumor","Colorectal Neoplasms",[159,160,161,162,163],"First-In-Class Investigational Agent","Peri-Nucleolar Compartment (PNC)","effective therapies against metastasis","Oral Administration","Maximum Recommended Starting Dose","2026-08-15",{"date":38,"type":41},{"date":167,"type":41},"2020-10-27",{"date":169,"type":22},"2028-12-31",{"name":171,"class":172},"National Cancer Institute (NCI)","NIH",2,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":125,"minAge":19,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":138},"100651856","phase-2-trastuzumab-rezetecan-followed-by-pyrotinib-and-trastuzumab-combined-with-capecitabine-as-first-line-treatment-for-advanced-her2-positive-breast-cancer-100651856","NCT07766772","Trastuzumab Rezetecan Followed by Pyrotinib, and Trastuzumab Combined With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer","A Single-arm, Exploratory Clinical Study of Sequential Use of Regorafenib in Combination With Pegylated Tyrosine Kinase Inhibitor and Trastuzumab in Combination With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer","Inclusion Criteria:\n\n* Female participants aged 18 to 75 years (inclusive)\n* Breast cancer must meet the following criteria:\n\n  * HER2-positive breast cancer confirmed by histology or cytology (HER2 positivity defined as IHC 3+ or ISH+ in primary or metastatic lesions); locally advanced or metastatic breast cancer not amenable to curative surgery (participants eligible for curative treatment are excluded);\n  * Clear HR status (HR-positive defined as ER and\u002For PR positive in primary or metastatic lesions, with ≥1% of tumor cells showing ER and\u002For PR staining);\n  * No prior systemic anticancer therapy during the recurrent\u002Fmetastatic phase (except ≤1 line of endocrine therapy allowed);\n  * For patients receiving (neo)adjuvant therapy, the interval between completion of systemic therapy (excluding endocrine therapy) and detection of recurrence\u002Fmetastasis must be \\>12 months.\n* ECOG performance status of 0 or 1.\n* Organ function deemed adequate for study drug administration by the investigator.\n* Pregnancy and contraception:\n\n  • Sexually active female participants (WOCBP) must agree to use highly effective contraception from the screening visit through 7 months after the last dose of investigational product, and must agree not to breastfeed.\n* Participants must voluntarily enroll in the study, sign informed consent, demonstrate good compliance, and be willing to cooperate with all study visits and procedures.\n\nExclusion Criteria:\n\n* Patients with active central nervous system metastases who have not undergone surgery or radiation therapy, except those whose condition has been stable for at least one month after treatment and who have discontinued corticosteroids for more than 2 weeks.\n* A history of other malignancies within the past 5 years, excluding cured cases of cutaneous basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma.\n* Presence of third-space fluid accumulation (e.g., large volume ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other means.\n* Patients who have received surgery (defined as major cancer-related surgery), radiation therapy, chemotherapy, immunotherapy, molecularly targeted therapy, biological therapy, or participated in other drug clinical trials within 4 weeks prior to the first dose of study medication.\n* Prior exposure to antibody-drug conjugates containing irinotecan derivatives as topoisomerase I inhibitors, such as T-DXd (DS-8201a).\n* Administration of live or live-attenuated vaccines within 4 weeks prior to the first dose of study medication.\n* History of immunodeficiency, including positive HIV test results, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.\n* Clinically significant cardiovascular disease, such as severe\u002Funstable angina, symptomatic congestive heart failure (NYHA ≥ II), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, or myocardial infarction occurring within 6 months prior to the first dose.\n* Known or suspected interstitial lung disease; presence of moderate to severe pulmonary conditions within 3 months prior to the first dose that could significantly impair respiratory function or interfere with assessment or management of drug-related pulmonary toxicity, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fobstructive bronchiolitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive\u002Frestrictive lung diseases, or cancerous lymphangitis; any autoimmune, connective tissue, or inflammatory disease involving the lungs, such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, or prior history of pneumonectomy. Patients with a prior history of interstitial lung disease grade ≥3 are excluded from this study.\n* Known hereditary or acquired bleeding tendency (e.g., hemophilia, coagulation disorders).\n* Active hepatitis B (HBsAg positive and HBV DNA ≥500 IU\u002FmL), hepatitis C (HCV antibody positive and HCV RNA above the upper limit of normal), cirrhosis; or severe infections requiring intravenous antibiotics, antivirals, or antifungal agents for control.\n* According to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0), patients whose toxicity from prior anticancer treatments has not recovered to ≤Grade 1 (except alopecia; certain tolerable chronic Grade 2 toxicities may be allowed at the investigator's discretion, such as Grade 2 peripheral neuropathy).\n* Known hypersensitivity to any of the investigational drugs, their excipients, or other monoclonal antibodies.\n* Other serious physical or psychiatric conditions or laboratory abnormalities that may increase the risk of participation in the study or interfere with study outcomes, or patients deemed unsuitable for participation by the investigator.","75 Years",{"count":183,"type":22},50,[185],"PHASE2","This study is a single-arm, exploratory clinical trial, aiming to include patients with HER2-positive advanced breast cancer. It intends to explore the efficacy and safety of trastuzumab combined with pyrotinib, capecitabine ± endocrine therapy as a first-line maintenance treatment for HER2+ advanced breast cancer after induction therapy with rucaparib trastuzumab.\n\nAfter the subjects meet the screening criteria and are enrolled, they receive induction therapy with rucaparib trastuzumab. Among them, patients without disease progression enter the maintenance treatment period and receive trastuzumab combined with pyrotinib, capecitabine ± endocrine therapy (±OFS) for treatment. Until disease progression, or toxicity becomes intolerable, or withdrawal of informed consent, or the investigator determines that the medication must be discontinued. During the study period, imaging evaluations are conducted according to the RECIST 1.1 standard, and the center assessment results are the final results.\n\nDuring the study period, the efficacy indicators such as PFS, ORR, DOR, CBR, and safety indicators of the subjects are evaluated according to the established trial standards, and statistical descriptions are conducted.",[188,29],"HER2 + Breast Cancer","NOT_YET_RECRUITING","2026-08-10",{"date":192,"type":41},"2026-08-14",{"date":194,"type":22},"2026-09-30",{"date":196,"type":22},"2031-12-31",{"name":198,"class":199},"Fujian Cancer Hospital","OTHER_GOV",{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":49},"100536339","phase-2-sequencing-antibody-drug-conjugates-in-erher2-lowultra-low-mbc-100536339","NCT06263543","Sequencing Antibody Drug Conjugates in ER+\u002FHER2 LOW\u002FULTRA LOW MBC","SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+\u002FHER2 LOW\u002FULTRA LOW MetaStatic Breast Cancer","SERIES","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Individuals ≥ 18 years of age.\n* 4\\. Histologically confirmed metastatic or advanced and unresectable breast cancer that is HER2 LOW\u002FULTRA LOW by local testing on either the primary or any metastatic site. HER2 LOW is defined as: (IHC 2+\u002FISH- or IHC 1+ (ISH- or untested)) and HER2 ULTRA LOW is defined as: IHC0+ (faint membrane staining up to 10%)\n* Histologically confirmed metastatic or advanced and unresectable breast cancer that is hormone receptor positive (estrogen receptor and\u002For progesterone receptor positive) defined as \\>1% on any metastatic site or the primary tumor.\n* Endocrine-refractory (as per investigator judgement) and may have received any number of prior endocrine therapies (alone or in combination with cyclin-dependent kinase (CDK)4\u002F6 inhibitor, everolimus, alpelisib, acapivasertib or inavolisib).\n* Received a CDK4\u002F6 inhibitor either alone or in combination with endocrine therapy (in the adjuvant or metastatic setting) with any duration of therapy permitted.\n* Received at least 1 but no more than 4 prior systemic chemotherapy regimens in the metastatic setting. Prior ADCs count as a line of systemic chemotherapy. Prior PARP inhibitor use counts as a line of systemic therapy.\n* Prior treatment with T-DXd (discontinued for progression and\u002For intolerance), which does not have to be the treatment immediately prior to enrollment on trial.\n* Documented clinical and\u002For radiographic disease progression after most recent therapy, unless immediate prior therapy was T-DXd which was discontinued for toxicity.\n* Measurable disease, as per RECIST V1.1 - a. If a patient has bone-only disease, they are eligible as long as there is a lytic lesion that is considered measurable. Blastic-only bone lesions are not allowed.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.\n* Adequate organ and bone marrow function within 28 days before enrollment. For all parameters listed below, the most recent results available must be used:\n\n  1. Hemoglobin ≥ 9 g\u002FdL. Note: Red blood cell transfusion is not allowed within 1 week prior to screening assessment.\n  2. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3. Note: Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment.\n  3. Platelet count ≥ 100,000\u002Fmm\\^3. Note: Platelet transfusion is not allowed within 1 week prior to registration.\n  4. Total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) if no liver metastases or \\\u003C 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastasis at baseline.\n  5. Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 ×ULN or \\\u003C 5 × ULN in patients with liver metastasis.\n  6. Serum albumin ≥ 2.5 g\u002FdL.\n  7. Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (calculated using the Cockcroft and Gault equation). Cockcroft-Gault equation: CrCl (mL\u002Fmin) = \\[140 - age (years)\\] × weight (kg) 72 × serum creatinine (mg\u002FdL) {× 0.85 for females}\n  8. International normalized ratio (INR) or prothrombin time (PT) and either partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n* Adequate treatment washout period before randomization, defined as:\n\n  1. Major surgery: ≥ 3 weeks\n  2. Radiation therapy including palliative and\u002For stereotactic radiation therapy ≥ 2 weeks\n  3. Hormonal therapy: ≥ 2 weeks\n  4. Targeted therapy (CDK4\u002F6i, PARP inhibitor, AKTinhibitor, mTOR inhibitor, PIK3CA inhibitor): ≥ 2 weeks\n  5. Immunotherapy (non-antibody-based therapy): ≥ 2 weeks\n  6. T-DXd: ≥ 3 weeks\n* Evidence of post-menopausal status or for individuals of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) at screening or baseline. Individuals of childbearing potential are defined as those who are not surgically sterile (i.e., underwent bilateral tubal occlusion, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal.\n* Individuals of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least one highly effective method of contraception from the time of registration through final study treatment. Not all methods of contraception are highly effective.\n* Non-sterilized male patients who are sexually active with a partner of childbearing potential must agree to use a condom with spermicide from registration and throughout duration of the study treatment.\n\nThe following are acceptable measures to prevent pregnancy:\n\n* Abstinence (not having sexual relations with a person who can get you pregnant)\n* Non-hormonal Intrauterine Device (IUD)\n* Vasectomy\n* Sterilization\n* Bilateral tubal occlusion\n\nExclusion Criteria:\n\n* Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.\n* Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline\u002Fscreening brain MRI. Patients who require treatment of brain metastases are eligible after 14 days post receipt of surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment.\n* Active serious infection requiring ongoing antibiotics.\n* History of an anaphylactic reaction to irinotecan.\n* Pregnant or breastfeeding.\n* Ongoing treatment with another investigational drug or other interventional trial.\n* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n* Any other condition that may put a participant at higher risk, at the discretion of the investigator.",{"count":209,"type":22},75,[185],"The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)\u002Fhuman epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+\u002FHER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd.",[213,96,29,97,214],"Breast Cancer","Human Epidermal Growth Factor 2 Low Breast Cancer",{"date":216,"type":41},"2026-08-12",{"date":218,"type":41},"2024-06-17",{"date":220,"type":22},"2028-12",{"name":222,"class":48},"Reshma L. Mahtani, D.O.",{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":138},"100637333","phase-2-metronomic-oral-paclitaxel-monotherapy-and-combined-immunotherapy-for-advanced-her2-negative-breast-cancer-a-two-stage-dose-exploration-and-expansion-trial-100637333","NCT07602907","Metronomic Oral Paclitaxel Monotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose-Finding and Expansion Study","Inclusion Criteria:\n\n1.Age ≥ 18 years, male or female. 2.Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer, regardless of hormone receptor (HR) status. For patients with HR+\u002FHER2-negative subtype: prior treatment with at least 1 line of CDK4\u002F6 inhibitor plus endocrine therapy is required, and the patient is considered no longer suitable for further endocrine therapy by the investigator.\n\n3.Patients have received 1-4 prior lines of systemic anti-tumor therapy for recurrent or metastatic disease.\n\n1. Line of therapy is defined as a systemic treatment regimen for recurrent or metastatic disease. First-line therapy is the first regimen used in the recurrent\u002Fmetastatic setting; any subsequent regimen that adds a new drug class (e.g., anti-angiogenic, immunotherapy) is considered a new line.\n2. Neoadjuvant or adjuvant therapy is not counted as a treatment line.\n3. Disease recurrence \\>6 months after neoadjuvant therapy is counted as first-line; recurrence ≤6 months is considered continuation of prior therapy and not a new line.\n4. Disease recurrence \\>12 months after adjuvant therapy is counted as first-line; recurrence ≤12 months is considered continuation of prior therapy, and subsequent regimens start at second-line.\n\n4.Prior treatment with taxane is allowed if both criteria are met:\n\n1. Interval from last dose of taxane to first study dose ≥ 4 weeks;\n2. No unresolved taxane-related Grade ≥3 toxicity in the past. 5.Body surface area (BSA): 1.38 m² ≤ BSA ≤ 1.87 m². 6.ECOG performance status 0-1. 7.At least one measurable lesion per RECIST 1.1. 8.Expected survival ≥ 12 weeks. 9.Adequate bone marrow function: ANC ≥ 1.5 × 10⁹\u002FL Platelets ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL 10.Adequate hepatic function: Total bilirubin ≤ 1.5 × ULN ALT\u002FAST ≤ 2.5 × ULN (no liver metastasis) ALT\u002FAST ≤ 5 × ULN (with liver metastasis) 11.Adequate renal function: Serum creatinine ≤ 1.5 mg\u002FdL Or creatinine clearance (Ccr) ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault formula) if serum creatinine \\>1.5 mg\u002FdL.\n\n12.Pre-existing peripheral neuropathy \\\u003C Grade 2 (CTCAE v6.0). 13.Known CNS metastases are allowed only if all of the following are met:\n\n1. CNS lesions stable for ≥4 weeks before enrollment, per RANO-BM criteria (no new lesions, target lesion volume change \\\u003C20%, no clear progression of non-target lesions on baseline and follow-up MRI).\n2. No corticosteroid use, or current dexamethasone ≤4 mg\u002Fday (or equivalent), with no dose increase within 7 days before enrollment.\n3. For patients with prior local CNS treatment: no imaging progression after treatment completion; neurologic symptoms stable for ≥2 weeks before first study dose; no steroid or ≤4 mg\u002Fday dexamethasone (or equivalent).\n4. No leptomeningeal disease.\n5. Whole-brain radiotherapy completed \\>14 days before enrollment.\n6. Prior stereotactic radiosurgery is allowed.\n7. Prior CNS surgery completed \\>28 days before enrollment with full recovery. 14.Voluntary participation and signed written informed consent.\n\nExclusion Criteria:\n\n1. Patients with suspected major infectious diseases, neurological disorders, or intestinal obstruction.\n2. Patients with a diagnosis of other cancer types (except non-melanoma skin cancer, cervical carcinoma in situ, or other cancers with no recurrence or metastasis for ≥5 years and considered cured).\n3. Patients who have undergone major surgery, including organ resection within 4 weeks before enrollment, or radiotherapy within 2 weeks before enrollment.\n4. Disease progression during prior taxane salvage therapy (at least 2 cycles completed), or recurrence\u002Fmetastasis within 12 months after neoadjuvant\u002Fadjuvant therapy.\n5. Patients requiring long-term concomitant use of P-glycoprotein (P-gp) inhibitors or immunosuppressive agents during the study.\n6. Patients receiving long-term treatment with steroids or other immunosuppressive agents (except oral, topical, or local injection).\n7. Patients with myocardial infarction, congestive heart failure, rapidly changing arrhythmia on ECG, severe or unstable angina pectoris, or other serious heart diseases.\n8. Patients with other severe medical diseases (uncontrolled diabetes mellitus and hypertension, chronic obstructive pulmonary disease (COPD), or dyspnea at rest due to any cause).\n9. Patients with a history of drug or alcohol abuse within the past 3 months.\n10. Pregnant or breastfeeding women, or patients who cannot or will not use effective contraceptive methods.\n11. Patients with or suspected of having bile acid excretion disorders.\n12. Active tendency of gastrointestinal bleeding or use of oral vitamin K antagonists (low-dose warfarin and acetylsalicylic acid are allowed as long as INR ≤2.0).\n13. Patients with severe hypersensitivity to the active ingredients or excipients of the study drugs.\n14. History of HIV seropositivity (HIV testing is not mandatory).\n15. Gastrointestinal dysfunction or diseases that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, poorly controlled nausea, vomiting, diarrhea, malabsorption syndrome), except patients with prior gastrectomy.\n16. Patients receiving enteral feeding (e.g., via nasogastric tube, nasointestinal tube, gastrostomy, or jejunostomy).\n17. Patients with visceral crisis, or patients with excessive tumor burden, rapid disease progression who urgently require rapid tumor shrinkage (e.g., conventional maximum tolerated dose chemotherapy) to relieve severe clinical symptoms per investigator assessment.\n18. Patients considered inappropriate for the clinical trial by the investigator.",{"count":230,"type":22},73,[185],"The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-tumor activity of metronomic oral paclitaxel solution in patients with advanced HER2-negative breast cancer who have previously received systemic anti-cancer treatments.\n\nThe main questions this study aims to answer are:\n\nWhat doses of metronomic oral paclitaxel solution can be safely administered to patients with advanced HER2-negative breast cancer? How well does metronomic oral paclitaxel solution control tumor growth? What side effects and treatment-related medical problems occur during treatment?\n\nThis study will include two stages. In the first stage, researchers will evaluate different dosing schedules of oral paclitaxel solution to identify a dose（OTD） with an acceptable balance between safety and potential anti-tumor activity. In the second stage, additional participants will receive the selected dose（OTD） to further evaluate its effectiveness and safety.\n\nParticipants will:\n\nReceive metronomic oral paclitaxel solution according to the assigned dose schedule.\n\nVisit the study clinic regularly for physical examinations, laboratory tests, tumor imaging assessments, and safety evaluations.\n\nComplete assessments of treatment response, side effects, and quality of life during the study.\n\nContinue follow-up after treatment to collect information about disease status and survival.",[29,65],"2026-08-06",{"date":236,"type":41},"2026-08-11",{"date":238,"type":22},"2026-08-04",{"date":240,"type":22},"2029-08-20",{"name":242,"class":48},"Zhejiang Cancer Hospital",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":125,"minAge":19,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":23,"phases":253,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":273},"100625804","phase-2-study-to-evaluate-the-safety-and-tolerability-of-camizestrant-in-combination-with-atirmociclib-in-women-with-advanced-breast-cancer-100625804","NCT07427394","Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer","A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)","SERENA-1b","Main Inclusion Criteria:\n\n* Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease.\n* Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products.\n* Eastern cooperative oncology group (ECOG)\u002FWorld Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks.\n* At least one lesion that is measurable and\u002For non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination.\n* Menopausal status\n\n  * Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study.\n  * Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age \\\u003C60 years with ≥12 months amenorrhea and post-menopausal hormone levels.\n* Histological or cytological confirmation of adenocarcinoma of the breast.\n* Participants of childbearing potential must agree to use one highly effective contraceptive measure.\n* Documentation of ER-positive tumor irrespective of progesterone receptor status.\n\nMain Exclusion Criteria:\n\n* A participant who has received 2 or more lines of CDK4\u002F6 inhibitors in the advanced disease setting.\n* A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting.\n* Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting.\n* Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible.\n* Inability to swallow oral medications.\n* Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia).\n* Presence of life-threatening metastatic visceral disease.\n* Any evidence of severe or uncontrolled systemic diseases.\n* Contraindication to or known intolerance\u002Fhypersensitivity of\u002Fto camizestrant or atirmociclib.",{"count":252,"type":22},24,[185],"A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor.",[29],[257,258,259,260,261,262,263,264],"Estrogen receptor (ER)-positive","Human epidermal growth factor receptor 2 (HER2)-negative","Cyclin-Dependent Kinase (CDK) 4 inhibitors","Pharmacokinetics","Anti-tumor activity","Selective Estrogen Receptor Degrader (SERD)","Safety","Tolerability",{"date":266,"type":41},"2026-08-07",{"date":268,"type":41},"2026-05-06",{"date":270,"type":22},"2027-12-29",{"name":272,"class":116},"AstraZeneca",6,{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":286,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":297},"100565140","phase-1-a-first-in-human-study-of-men2312-in-adults-with-advanced-breast-cancer-100565140","NCT06638307","A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer","A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer","Key Inclusion Criteria:\n\n* Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.\n* Presence of genetic alterations in PIK3CA\u002FAKT1\u002FPTEN in participants' tumor tissue.\n* Participant must have received at least 1 prior line of endocrine therapy for advanced\u002Fmetastatic disease or participant who has radiological evidence of breast cancer recurrence or progression during or within 12 months from the end of adjuvant treatment with endocrine therapy, as these participants are considered as first-line relapsed participants.\n* Progression on previous cyclin-dependent kinase 4 and 6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required.\n\nKey Exclusion Criteria:\n\n* Active or newly diagnosed central nervous system metastases.\n* Participants with advanced, symptomatic visceral spread, who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \\>50%.\n* Participants with any toxicities related to prior radiation therapy that have not resolved to baseline or to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2).\n\nNote: Other inclusion\u002Fexclusion criteria may apply.",{"count":282,"type":22},240,[92],"This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.",[29],[287,288,29,289],"First-In-Human","MEN2312","KAT6",{"date":266,"type":41},{"date":292,"type":41},"2024-10-25",{"date":294,"type":22},"2029-10-23",{"name":296,"class":116},"Stemline Therapeutics, Inc.",45,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":312,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":329},"100614610","phase-3-phase-iii-study-to-evaluate-the-safety-efficacy-and-impact-on-quality-of-life-of-capivasertib-alongside-standard-of-care-endocrine-treatment-in-patients-with-hrher2--advanced-breast-cancer-and-progression-on-prior-endocrine-based-treatment-100614610","NCT07281833","Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+\u002FHER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment","An Interventional, Open-label, Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+\u002FHER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment","CAPIcorn","Inclusion Criteria:\n\n1. Females (≥18 years, pre-, peri- or post-menopausal) and males (≥18 years) at the time of signing the informed consent form\n\n   a. Pre-menopausal (and peri-menopausal, i.e., those that do not meet the criteria for post menopausal defined below) women can be enrolled if amenable to treatment with an GNRH agonist. Patients are to have commenced concomitant treatment with GNRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue it for the duration of the study.\n\n   b. Post-menopausal women are defined as: i. aged ≥60 years of age, OR ii. aged \\\u003C60 years of age and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments\u002Fchemotherapy\u002Fovarian suppression\u002Ftamoxifen or similar. These patients should also have serum oestradiol and follicle stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for post-menopausal females, OR iii. documented bilateral oophorectomy.\n2. Histologically confirmed HR+\u002FHER2- breast cancer determined from the most recent tumour sample (primary or metastatic) as per WHO classification. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor.\n\n   Therefore, tumours must be:\n\n   a. ER+ defined as ≥1% of tumour cells stain positive for ER on immunohistochemistry (IHC) or, if no percentage is available, then an Allred IHC score of ≥3\u002F8, b. Progesterone receptor positive defined as ≥1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≥3\u002F8; or progesterone receptor negative defined as \\\u003C1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≤2\u002F8; or progesterone receptor unknown, and c. HER2- defined as 0 or 1+ intensity on IHC, or 2+ intensity on IHC and no evidence of amplification on in situ hybridisation (ISH), or if IHC not done, no evidence of amplification on ISH.\n3. Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression (the cancer should have shown progression during or after most recent therapy); locally advanced disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible).\n4. Patients are to have received treatment with an ET (endocrine-based therapy) containing regimen (single agent or in combination) and have:\n\n   a. Radiological evidence of breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an ET, OR b. Radiological evidence of progression while on prior ET administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy).\n5. Presence of one or more of the PIK3CA\u002FAKT1\u002FPTEN biomarkers, preferably determined in tumour tissue\\*\n6. Decision to newly initiate capivasertib\n7. Informed consent provided by patient prior to participation in the trial and before initiation of any study-specific measures\n8. A. Female patients of childbearing potential at inclusion must have a negative pregnancy test (serum) and additionally, - surgically sterile, - carry an intrauterine device (combined with a barrier method),\n\n   * having received a bilateral tubal ligation\u002Focclusion (combined with a barrier method),\n   * or using a highly effective method of contraception for the duration of the study (from the time they sign consent) and for 3 months after the last dose of capivasertib \u002F GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy.\n   * Total\u002Ftrue abstinence When the patient refrains from any form of sexual intercourse and this is in line with their usual and\u002For preferred lifestyle; this must continue for the duration of the study and for 3 months after the last dose of capivasertib\u002F GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy.\n   * Vasectomised sexual partner (with participant assurance that partner received post-vasectomy confirmation of azoospermia) combined with a barrier method or sexual partner with bilateral orchiectomy\n   * Hormonal contraception is not acceptable.\n\n8\\. B. Male patients must either be\n\n* surgically sterile\n* or using an highly effective method of contraception for the duration of the study (from the time they sign consent) and for 4 months after the last dose of capivasertib\u002F GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy in a partner.\n* Sexually abstinent men (i.e., refraining from heterosexual intercourse during the entire study duration) must continue for 4 months after the last dose of capivasertib\u002F GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy in a partner.\n* Male patients who intend to be sexually active with a woman of childbearing potential, must use a condom plus spermicide upon entering the study and until 4 months after the last dose of capivasertib and for 2 years after the last dose of fulvestrant to prevent pregnancy in a partner.\n* Highly effective methods of contraception should be considered in female partners of men taking capivasertib plus fulvestrant who are of childbearing potential.\n\n  9\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks and life expectancy of ≥12 weeks\n\n  \\*A list of eligible alterations and test procedures is provided in the protocol.\n\nExclusion Criteria:\n\n* Patients eligible for inclusion in this study must not meet any of the following criteria:\n\n  1. Absence of an alteration in the PIK3CA\u002FAKT1\u002FPTEN biomarkers\n  2. Previous enrolment in the present study\n  3. Participation in another clinical study with any investigational medicinal product and still on IMP treatment or have participated in an interventional study that remains blinded\n  4. A disease burden that makes the patient ineligible for endocrine-based therapy per the investigator's best judgement (e.g., symptomatic visceral disease that is potentially life threatening in the short-term)\n  5. Known history of drug or alcohol abuse within 1 year of screening\n  6. Except for alopecia, any unresolved toxicities from prior therapy CTCAE Grade ≥2 at the time of starting study treatment\n  7. Leptomeningeal metastases\n  8. Spinal cord compression or brain metastases unless asymptomatic, treated and stable, and not requiring steroids within 4 weeks prior to study treatment initiation\n  9. Clinically significant abnormalities of glucose metabolism as defined by any of the following:\n\n     a. HbA1c ≥8.0% (63.9 mmol\u002Fmol) at screening. Note: for any patient with evidence of impaired glucose control or insulin resistance refer to the Capivasertib Toxicity Management Guidelines.\n  10. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n      1. Absolute neutrophil count \\\u003C1.5 × 109\u002FL\n      2. Platelet count \\\u003C100 × 109\u002FL\n      3. Haemoglobin \\\u003C9 g\u002FdL (\\\u003C5.59 mmol\u002FL). \\[NOTE: any blood transfusion must be \\>14 days prior to the determination of a haemoglobin ≥9 g\u002FdL (≥5.59 mmol\u002FL)\\]\n      4. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \\>2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or \\>5 × ULN in the presence of liver metastases\n      5. Total bilirubin \\>1.5 × ULN (Patients with confirmed Gilbert's syndrome may be included in the study)\n      6. Creatinine \\>1.5 × ULN concurrent with creatinine clearance \\\u003C50 mL\u002Fmin (measured or calculated by Cockcroft and Gault equation); creatinine clearance is only required when creatinine is \\>1.5 × ULN\n  11. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, or active infection including tuberculosis, hepatitis B, hepatitis C, and human immunodeficiency virus (HIV), including those who have confirmed COVID 19 and any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent. Screening for chronic conditions is not required.\n\n      Note: Known active hepatitis B or C infection, positive hepatitis C antibody, positive hepatitis B virus surface antigen. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients receiving antiretroviral therapies which are strong inhibitors or inducers of CYP3A4 will be excluded due to the potential for drug-drug interaction with capivasertib\n  12. Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or subcutaneous injections of GNRH agonist (if applicable)\n  13. Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib\n  14. Previous allogenic bone marrow or solid organ transplant\n  15. History of another primary malignancy\n  16. Known immunodeficiency syndrome\n  17. Mean resting corrected QT interval \\>470 ms, obtained from triplicate ECGs performed at screening. History of QT prolongation associated with other medications that required discontinuation of that medication \\[Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.\\]\n  18. Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study based on the Investigator judgement with cardiologist consultation recommended.\n  19. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, hypokalaemia of Grade \\>1, potential for Torsades de Pointes, congenital long QT syndrome\n  20. Experience of any of the following procedures or conditions in the preceding 3 months: coronary artery bypass graft, angioplasty, myocardial infarction, unstable angina pectoris. Congestive heart failure New York Heart Association (NYHA) ≥grade 2.\n  21. History of hypersensitivity to active or inactive excipients of capivasertib, fulvestrant and GNRH agonists (if applicable, i.e., concomitant GNRH agonist required in this study) or drugs with a similar chemical structure or class to capivasertib, fulvestrant or GNRH agonists (if applicable)\n  22. Radiotherapy within 14 days prior to first dose of capivasertib\n  23. Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.\n  24. Evidence of dementia altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent\n  25. Pregnancy or breastfeeding\n  26. Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded\n  27. More than 2 lines of endocrine-based therapy for inoperable locally advanced or mBC\n  28. More than 1 line of chemotherapy for inoperable locally advanced or mBC. Adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for mBC\n  29. Prior treatment with any of the following:\n\n      1. AKT, PIK3 and mTOR inhibitors\n      2. ngSERD (Note: prior treatment with fulvestrant (=SERD) is allowed!)\n      3. Nitrosourea or mitomycin C within 6 weeks prior to study treatment initiation\n      4. Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation. A longer washout period may be required for drugs with a long half-life (e.g., biologics) as agreed by the sponsor\n      5. Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort) or drugs that are sensitive to CYP3A4 inhibition within 1 week prior to study treatment initiation.\n      6. Any concomitant medication that may interfere with capivasertib or fulvestrant safety and efficacy based on the Investigator´s Brochure of capivasertib and the prescribing information of fulvestrant and local clinical guidelines, e.g., that are known to be associated with Torsade de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4).",{"count":307,"type":22},250,[61],"This is a multicentre phase-III-trial to evaluate the use of capivasertib in patients with HR+\u002FHER2- advanced breast cancer and progression on prior endocrine-based treatment.\n\nThe goal of this study is\n\n1. To evaluate benefit of capivasertib regarding time to next treatment (TTNT1) - i.e., time \"on treatment\" with capivasertib.\n2. To evaluate the benefits of patient reported outcome(PRO)-adherence regarding the deterioration of quality of life (DQoL)-free interval.\n\nThere is no active comparison group but a historical control group consisting of data of patients treated within the CAPItello-291-study..\n\nParticipants will take capivasertib accompanied by standard of care endocrine treatment and are asked to document ther quality of life on standardised questionnaires. Optionally, patients can use eHealth support via their own smart phones.",[213,311,29,96,65],"HR-positive Breast Cancer",[103,313,314,315,316,317,318,319,320],"advanced, metastatic","metastatic","progression","HR+","HER2-","capivasertib","eHealth","ePRO",{"date":322,"type":41},"2026-08-05",{"date":324,"type":41},"2025-11-27",{"date":326,"type":22},"2030-03",{"name":328,"class":48},"Women's Cancer Study Group GmbH",16,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":125,"minAge":19,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":355},"100616808","phase-1-a-trial-to-evaluate-ovarian-suppression-following-subcutaneous-zoladex-108-mg-in-premenopausal-women-with-hr-her2--advanced-breast-cancer-100616808","NCT07310420","A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer","Phase 1 Single-arm, Open-label, Multicenter Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced Breast Cancer","Inclusion Criteria:\n\n1. Age and gender:\n\n   1. Gonadotropin-releasing Hormone (GnRH) treatment-naïve: Female participants aged 18 to 55 years, inclusive.\n   2. GnRH treatment-exposed \\\u003C6 months: Female participants aged 18 to 55 years, inclusive, if GnRH treatment started within \\\u003C6 months of signing the informed consent.\n2. Advanced or metastatic breast cancer: Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent per investigator's assessment.\n3. HR+: Either estrogen receptor positive (ER+) or progesterone receptor positive (PR+) breast cancer, defined as 1% to 100% of tumor nuclei are positive for ER or PR via immunohistochemistry.\n4. HER2-: Via American Society of Clinical Oncology, College of American Pathology (ASCO-CAP) guidelines.\n5. Prior treatment:\n\n   1. Participants may have received prior radiotherapy.\n   2. Participants may have received or be receiving a cyclin-dependent kinase (CDK) 4\u002F6 inhibitor, a phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha-protein kinase B (PIK3CA-AKT) inhibitor, or bisphosphonates if initiated and at a stable dose for at least 2 weeks before trial enrollment.\n   3. GnRH treatment-naïve participants will have no history of GnRH agonist or other endocrine therapy in the advanced\u002Fmetastatic setting.\n   4. GnRH treatment-exposed participants may have received a GnRH agonist or other endocrine therapy provided they had established premenopausal status prior to initiating GnRH agonist therapy, within 6 months prior to trial enrollment.\n6. Chemotherapy History:\n\n   a. A participant may have received adjuvant or neoadjuvant chemotherapy in early-stage breast cancer.\n\n   i. Any participant who received prior adjuvant or neoadjuvant chemotherapy are eligible provided the criteria for premenopausal status.\n\n   b. All chemotherapy-related toxicities must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 ≤Grade 1 before trial participation, except for alopecia, peripheral neuropathy, or paresthesia (≤Grade 2).\n7. Concurrent Medications:\n\n   1. Cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitors are permitted if initiated and tolerated without ongoing toxicity CTCAE v6.0 \\>Grade 1 for at least 2 weeks before trial enrollment.\n   2. PIK3CA\u002FAKT inhibitors are permitted if started at least 2 weeks before the trial and tolerated without ongoing toxicity CTCAE v6.0 \\>Grade 1.\n   3. Concomitant use of bisphosphonates is permitted if initiated and tolerated without ongoing toxicity CTCAE v6.0 \\>Grade 1 for at least 2 weeks before trial enrollment.\n   4. Concomitant use of endocrine therapy (eg, aromatase inhibitor, fulvestrant, or other FDA-approved selective estrogen receptor degraders \\[SERDs\\]) is permitted.\n8. Informed consent: Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions.\n9. Contraceptive use: Female participants may be enrolled if they are:\n\n   1. Practicing true abstinence for at least 28 days prior to investigational product (IP) administration until 30 days after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1, OR\n   2. Using 2 forms of highly effective nonhormonal contraception, including 1 physical barrier (condom or diaphragm) plus another nonhormonal method (eg, intrauterine device, spermicidals) from Screening or at least 2 weeks prior to IP administration (whichever is earlier) until 30 days after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1.\n10. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n\nExclusion Criteria:\n\n1. Postmenopausal: Naturally or surgically postmenopausal (regardless of age).\n2. Body mass index (BMI): \\\u003C18 kg\u002Fm\\^2 or \\>35.0 kg\u002Fm\\^2.\n3. Prior surgical or radiation procedures: History of bilateral oophorectomy or prior radiotherapy to the ovaries.\n4. Recent radiotherapy:\n\n   1. Radiotherapy for breast cancer within 4 weeks prior to trial enrollment.\n   2. All radiotherapy-related toxicities (except alopecia) must have recovered to CTCAE v6.0 ≤Grade 1 before trial enrollment.\n5. Radiotherapy during trial: Planned radiotherapy during trial period.\n6. Selective estrogen receptor modulator (SERM) use during trial: Participants may not receive tamoxifen or other SERMs during the trial and must discontinue any SERMs prior to enrollment, other endocrine therapies (eg, aromatase inhibitor, fulvestrant, or other FDA-approved SERDs) are allowed.\n7. Hypersensitivity: Known hypersensitivity, idiosyncratic, or allergic reactions to goserelin, GnRH, GnRH agonists\u002Fanalogs, or any trial drug components.\n8. Expected survival: Estimated life expectancy \\\u003C6 months from the start of trial therapy, based on the principal investigator's (PI) clinical judgment.\n9. Performance status: ECOG performance status ≥3.\n10. Life-threatening disease or metastasis: Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, symptomatic pulmonary lymphangitic spread, symptomatic pleural disease, or any symptomatic brain\u002Fleptomeningeal metastases (proven or suspected). Participants with asymptomatic or stable\u002Ftreated brain metastases are eligible to enroll if neurologically stable and are receiving a stable or decreasing corticosteroid dose at the time of enrollment. Participants with discrete pulmonary parenchymal metastases are eligible if respiratory function is not compromised.\n11. Hepatic function:\n\n    1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2×upper limit of normal (ULN) if no liver metastases, or \\>5×ULN with liver metastases.\n    2. Total bilirubin ≥1.5×ULN (≥2.5×ULN for Gilbert's syndrome).\n12. Renal function: Creatinine clearance (CrCl) ≤30 mL\u002Fmin as calculated by the Cockcroft-Gault formula.\n13. Hematologic parameters:\n\n    1. Hemoglobin (Hgb) \\\u003C8.0 g\u002FdL.\n    2. White blood cell (WBC) count \\\u003C3000\u002Fmm\\^3.\n    3. Platelets \\\u003C100,000\u002Fmm\\^3.\n14. Other malignancies: Active malignancy within the past 3 years, except for adequately treated basal or squamous cell skin cancer or in situ cervical carcinoma.\n15. Concurrent medical conditions: Presence of any severe, uncontrolled, or serious illness, medical condition (including psychiatric\u002Faddictive disorders), or clinical finding that could compromise trial adherence, as assessed by the investigator.\n16. Investigational drug exposure: Exposure to any investigational drug or device within 30 days prior to trial enrollment.\n17. Pregnancy: Participant has childbearing potential with a positive serum pregnancy test or positive urine pregnancy test at Screening or Day 1.\n18. Breastfeeding: Participant is currently breastfeeding.\n19. Contraceptive use: Sexually active with a male partner and not willing to use nonhormonal contraceptive methods throughout the trial. Exceptions: male partner is vasectomized (provided he is her sole sexual partner, and he has received medical assessment of the surgical success), participant has had bilateral salpingectomy or tubal occlusion hysterectomy.\n20. Cardiac conditions:\n\n    1. Corrected QT interval (QTc) using Fridericia's correction (QTcF) \\>450 ms at Screening.\n    2. Uncontrolled or symptomatic heart disease, including:\n\n    i. New York Heart Association (NYHA) Class III or IV heart failure.\n\n    ii. Myocardial infarction within the past 6 months.\n\n    iii. Unstable angina or significant arrhythmias requiring intervention.\n\n    c. Documented congenital QT syndrome.\n21. Clinically relevant abnormal medical history or abnormal findings on physical examination, vital signs, echocardiogram (ECG), or laboratory tests at Screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant.\n22. History of multiple and\u002For severe allergies to drugs or foods or a history of severe anaphylactic reaction.\n23. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within the last 1 year prior to IP administration.\n24. Major surgery within 30 days prior to IP dosing or a major surgical procedure planned during the trial.\n25. Any other condition that precludes adequate understanding, cooperation, and compliance with trial procedures or any condition that could pose a risk to the participant's safety, as per the investigator's judgment.","55 Years",{"count":339,"type":22},88,[92],"The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).",[29],[344,345,316,317,213,346],"Ovarian Suppression","ZOLADEX","Goserelin Implant","2026-08-03",{"date":238,"type":41},{"date":350,"type":22},"2026-08-30",{"date":352,"type":22},"2027-03-30",{"name":354,"class":116},"TerSera Therapeutics LLC",20,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":366,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":376,"locationsCount":378},"100591599","phase-3-phase-3-study-of-rly-2608--fulvestrant-vs-capivasertib--fulvestrant-as-treatment-for-locally-advanced-or-metastatic-pik3ca-mutant-hrher2--breast-cancer-100591599","NCT06982521","Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+\u002FHER2- Breast Cancer","A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+\u002FHER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4\u002F6 Inhibitor","ReDiscover-2","Inclusion Criteria:\n\n* Patient has ECOG performance status of 0-1\n* One or more known primary oncogenic PIK3CA mutation(s)\n* Adult females, pre- and\u002For post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with a gonadotropin-releasing hormone (GnRH) agonist. Patients are to have commenced treatment with a GnRH agonist at least 2 weeks prior to randomization and must be willing to continue on it for the duration of the study.\n* Histologically or cytologically confirmed diagnosis of HR+\u002FHER2- locally advanced or metastatic breast cancer (ABC) with radiological or objective evidence of recurrence or progression; locally advanced disease must not be amenable to resection with curative intent\n* Measurable disease per RECIST v1.1 or evaluable bone-only disease.\n* Must have radiological evidence of progression on or after previous treatment for HR+\u002FHER2- ABC with:\n\n  1. At least 1 and no more than 2 lines of endocrine therapy (ET) in the (neo)adjuvant setting with recurrence on or within 12 months of completion or in the ABC setting\n  2. Only 1 prior line of CDK4\u002F6 inhibitor therapy in one of the following settings:\n\n     1. CDK4\u002F6 inhibitor + ET in the ABC setting\n     2. CDK4\u002F6 inhibitor therapy in the adjuvant setting if progression occurred during or within 12 months of completion of adjuvant CDK4\u002F6 inhibitor with ET\n     3. Patients who progressed during or within 12 months of completion of adjuvant CDK4\u002F6 inhibitor and after receiving CDK4\u002F6 inhibitor therapy in the advanced setting are considered to have had \\>1 prior line of CDK4\u002F6 inhibitor and are not eligible\n\nExclusion Criteria:\n\n* Prior treatment with any of the following:\n\n  1. CDK2 inhibitors. Prior treatment with other investigational CDK inhibitors could be permitted upon discussion and approval from the Sponsor\n  2. PIK3, AKT, or mTOR inhibitors or any agent whose mechanism of action is the inhibit the PIK3\u002FAKT\u002FmTOR pathway\n  3. Immunotherapy\n  4. Antibody drug conjugates\n* Type 1 diabetes, or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥ 140 mg\u002FdL (7.8 mmol\u002FL), or glycosylated hemoglobin (HbA1c) ≥7.0% (≥ 53 mmol\u002Fmol).\n* Clinically significant, uncontrolled cardiovascular disease\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events\n* Known active uncontrolled or symptomatic CNS metastases associated with progressive neurological symptoms or requiring ongoing corticosteroids or anticonvulsants for symptomatic control\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\n* History of hypersensitivity to fulvestrant or drugs in a similar class as fulvestrant, zovegalisib, or capivasertib, including their excipients\n* Known activating AKT mutations, loss-of-function PTEN mutations, or loss of PTEN expression resulting in oncogenic pathway activation downstream of PI3K",{"count":365,"type":22},540,[61],"This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+\u002FHER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4\u002F6 inhibitor.",[369,370,371,213,96,29],"PIK3CA Mutation","HER2- Negative Breast Cancer","Hormone Receptor Positive Tumor",{"date":322,"type":41},{"date":374,"type":41},"2025-08-26",{"date":196,"type":22},{"name":377,"class":116},"Relay Therapeutics, Inc.",222,{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":23,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":401},"100553499","phase-2-safety-and-efficacy-of-t-dxd-vs-cdk46i-based-et-as-first-line-therapy-of-hr-positive-and-her2-lowultralow-advanced-breast-cancer-patients-classified-as-non-luminal-subtype-100553499","NCT06486883","Safety and Efficacy of T-DXd vs. CDK4\u002F6i-based ET as First-line Therapy of HR-positive and HER2-low\u002FUltralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype","A Randomized Phase II Study to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan Versus CDK4\u002F6 Inhibitor-based Endocrine Therapy as First-line Therapy of HR-positive and HER2-low\u002FUltralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype According to Gene Expression Profiling.","PONTIAC","Inclusion Criteria:\n\n1. Patients must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female or male patients ≥ 18 years of age at the time of signing ICF.\n3. ECOG performance status of 0-1.\n4. Minimum life expectancy of ≥ 12 weeks at screening.\n5. Evidence of HER2-low expression (1+ by immunohistochemistry (IHC) or 2+ and negative by an in situ hybridization \\[ISH\\] test) or HER2-ultralow (IHC 0 with faint membrane staining and in ≤ 10% of tumor cells) breast cancer according to the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines determined by a MEDSIR's designated central laboratory, using Ventana 4B5 antibody. This assessment has to be done on the most recently available (archived or newly collected) formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (≤ 6 weeks or FFPE of a tumor sample obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion, excluding bone metastases.\n6. Non-luminal breast cancer subtype as per central PAM50 analysis determined in the most recently available (archived or newly collected) FFPE tumor tissue blocks (≤ 6 weeks or FFPE of a tumor sample obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion with the exception of bone metastases.\n7. Patients must have HR-positive (estrogen receptor \\[ER\\] and\u002For progesterone receptor \\[PgR\\]-positive defined as ≥ 1% positive stained cells) status according to the most recent ASCO\u002FCAP guidelines locally determined prior to study entry.\n8. Unresectable locally recurrent or metastatic breast cancer documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.\n9. Evaluable disease according to RECIST v.1.1. Patients with bone-only disease are not allowed. Patients with bone metastases with soft tissue masses measuring \\> 10 mm are eligible.\n10. Patients must have endocrine resistance criteria:\n\n    • disease progression during adjuvant ET or within the first year of completing adjuvant ET;\n\n    or endocrine sensitivity criteria:\n\n    • de novo metastatic disease or disease progression ≥ 12 months after completing adjuvant ET with at least one of the following requirements:\n    * Estrogen receptor ≤ 50% positive stained cells;\n    * and\u002For high histological grade or Ki67 \\> 50% on primary tumor;\n    * and\u002For liver metastases;\n    * and\u002For known non-luminal subtype as per local PAM50 analysis.\n11. No prior treatment with any systemic therapy for advanced disease.\n12. Patients treated with a CDK4\u002F6i in the adjuvant setting with a treatment-free interval (TFI) ≥ 12 months following CDK4\u002F6i treatment completion are eligible.\n13. Patients have adequate bone marrow, liver, and renal function:\n\n    * Hematological (without platelet, red blood cell transfusion, and\u002For granulocyte colony-stimulating factor support within 14 days before first study treatment dose): White blood cell (WBC) count \\> 3.0 x 109\u002FL, absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL, platelet count ≥ 100.0 x 109\u002FL, and hemoglobin ≥ 9.0 g\u002FdL (≥ 5.6mmol\u002FL).\n    * Hepatic: Serum albumin ≥ 2.5 g\u002FdL; total bilirubin ≤ 1.5 times upper limit of normal (x ULN) (≤ 3 x ULN in patients with liver metastases or know history of Gilbert's disease); alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver\u002For bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN (≤ 5 x ULN in patients with liver metastases).\n    * Renal: Creatinine clearance ≥ 30 mL\u002Fmin as determined by Cockcroft Gault (using actual body weight).\n    * Coagulation: International normalized ratio or prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN.\n14. Resolution of all acute toxic effects of prior anti-cancer therapy to Grade ≤ 1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v.5.0) (except for alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).\n15. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before study treatment initiation. In addition, they must agree to use one highly effective method of birth control from the time of screening until 7 months after the last dose of T-DXd, or within the time period specified per local prescribing guidelines after the final dose of physician's choice of CDK4\u002F6i plus ET. Female patients must refrain from egg cell donation and breastfeeding during this same period.\n16. Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until 4 months after the last dose of T-DXd, or within the time period specified per local prescribing guidelines after the final dose of physician's choice of CDK4\u002F6i plus ET. Male participants must not donate or bank sperm during this same period.\n17. Patients must be accessible for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Current participation in another therapeutic clinical trial, except other translational studies.\n2. Treatment with approved or investigational cancer therapy within 3 weeks prior to initiation of study drug.\n3. Treatment with chloroquine\u002Fhydroxychloroquine within 14 days prior to initiation of study drug.\n4. Have previously been treated with T-DXd and\u002For fulvestrant. Note: patients who experienced relapse after more than 1 year from completion of fulvestrant are eligible.\n\n   Note I: previous treatment with anti-HER2 therapies in (neo-) adjuvant setting will be allowed for participants who showed conversion from HER2-positive expression in primary breast tumor sample to HER2-low or HER2-ultralow expression (HER2 loss) in relapsed tumor sample.\n5. Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \\[pleural, pericardial, and\u002For peritoneal\\] and pulmonary lymphangitis).\n6. Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of CDK4\u002F6i, such as history of GI surgery which may result in intestinal blind loops and patients with clinically significant gastroparesis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease, or diarrhea of CTCAE Grade \\> 1.\n7. Known central nervous system (CNS) involvement (brain metastases and\u002For leptomeningeal carcinomatosis). Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy.\n8. Have a concurrent malignancy or malignancy within 5 years of study enrollment with the exception of carcinoma in situ of the cervix and basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.\n9. Known allergy or hypersensitivity reaction to any of the investigational medicinal products (IMPs) or their inactive ingredients.\n10. Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks prior to start of study treatment.\n11. Major surgical procedure or significant traumatic injury within 4 weeks before the first dose of study treatment or anticipation of need for major surgery within the course of the study treatment.\n12. Has an active cardiac disease or a history of cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following:\n\n    * Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic congestive heart failure (NYHA Class II to IV), unstable angina pectoris, or a recent (\\\u003C 6 months) cardiovascular event including stroke. Participants with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation to rule out myocardial infarction.\n    * Left ventricular ejection fraction (LVEF) \\\u003C 55% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO).\n    * History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia), which is symptomatic or requires treatment (NCI-CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers will be permitted to enroll.\n    * QT interval corrected by Fridericia's formula (QTcF) prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG).\n    * History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes.\n    * Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.\n13. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of the study enrolment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, post COVID-19 pulmonary fibrosis, etc.), and any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy (complete).\n14. Has a history of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n15. Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol.\n16. Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV DNA test), and \\> 6 months off anti-viral treatment are eligible. Those participants should be closely monitored for HBV reactivation and have access to a local hepatitis B expert during and after the study.\n17. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n18. Patients with HCV co-infection or history of HCV co-infection.\n19. Patients with cirrhosis or fibrosis on prior imaging or biopsy.\n20. Has an active primary immunodeficiency or known human immunodeficiency virus (HIV) infection.\n21. Other active uncontrolled infection at the time of enrollment.\n22. Receipt of live or attenuated vaccine within 30 days prior to the first dose of study treatment.\n23. A history of uncontrolled seizures, CNS disorders, or serious and\u002For unstable pre-existing psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs or interfering with subject safety.\n24. Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers (for examples, see the Prohibited Medications Section).\n25. Known substance abuse or any other concurrent severe and\u002For uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation.\n26. Inability or unwillingness to comply with the requirements of the protocol in the opinion of the investigator.",{"count":388,"type":22},200,[185],"This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive\u002FHER2-negative and classified as non-luminal by gene expression profiling (PAM50). Patients will be treated with trastuzumab deruxtecan (T-DXd) or with physician's choice of CDK4\u002F6 inhibitor (CDK4\u002F6i) plus endocrine therapy (ET). The main purpose of the study is to analyze the efficacy of T-DXd in patients who have HR-positive and HER2-low\u002Fultralow advanced breast cancer classified as non-luminal subtype.",[29,392,98],"Advanced Breast Carcinoma","2026-07-29",{"date":395,"type":41},"2026-07-30",{"date":397,"type":41},"2025-06-30",{"date":399,"type":22},"2028-01",{"name":80,"class":48},79,{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":422},"100545349","phase-3-saruparib-azd5305-plus-camizestrant-or-plus-endocrine-therapy-compared-with-cdk46-inhibitor-plus-endocrine-therapy-or-plus-camizestrant-in-hr-positive-her2-negative-ihc-0-1-2-ish-non-amplified-brca1-brca2-or-palb2m-advanced-breast-cancer-100545349","NCT06380751","Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4\u002F6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+\u002F ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer","A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With Physician's Choice CDK4\u002F6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+\u002F ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)","EvoPAR-BR01","Inclusion Criteria:\n\n* Adult females, pre\u002Fperi-menopausal and\u002For post-menopausal, and adult males\n* Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer\n* Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease\n* ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks\n* FFPE tumour tissue from each participant\n* Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2\n* Adequate organ and marrow function\n\nExclusion Criteria:\n\n* Participants with history of MDS\u002FAML or with features suggestive of MDS\u002FAML\n* Participants with any known predisposition to bleeding\n* Any history of persisting severe cytopenia\n* Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections\n* Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection\n* History of another primary malignancy\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy excluding alopecia\n* Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease\n* Evidence of active and uncontrolled hepatitis B and\u002For hepatitis C\n* Evidence of active and uncontrolled HIV infection\n* Active tuberculosis infection\n* Cardiac criteria, including history of arrythmia and cardiovascular disease\n* Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions\n* Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study\n* Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study treatment\n* Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET for up to 28 days total before randomisation\n* Prior treatment within 28 days with blood product support or growth factor support\n* Any systemic concurrent anti-cancer treatment\n* Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation:\n\n  1. Strong and moderate CYP3A4 inducers\u002Finhibitors\n  2. Sensitive CYP2B6 substrates\n  3. Substrates of CYP2C9 and\u002For CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.\n* Concomitant use of drugs that are known to prolong QT and have a known risk of TdP\n* Systemic use of atropine\n* The following exclusion criteria apply to treatments administered for early breast cancer:\n\n  1. Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy\n  2. Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and\u002For platinum agent for early breast cancer\n  3. Disease progression ≤ 1 year (365 days) from the last dose with a CDK4\u002F6i in the adjuvant setting\n  4. Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD including camizestrant.",{"count":411,"type":22},788,[61],"The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4\u002F6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+\u002F ISH non-amplified) advanced breast cancer",[29],"2026-07-28",{"date":395,"type":41},{"date":418,"type":41},"2024-08-01",{"date":420,"type":22},"2031-12-30",{"name":272,"class":116},302,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":437,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":4},"100646977","phase-3-t-dxd-based-therapy-followed-by-endocrine-therapy-plus-dual-her2-blockade-in-first-line-her2-hr-metastatic-breast-cancer-and-retreatment-with-t-dxd-100646977","NCT07683754","T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+\u002F HR+ Metastatic Breast Cancer and Retreatment With T-DXd","A Global, Interventional, Open-label Trial of T-DXd-based Therapy Followed by Palbociclib, Endocrine Therapy and Dual HER2 Blockade in First-line HER2+\u002F HR+ Advanced or Metastatic Breast Cancer and Retreatment With T-DXd (DB-Guide)","DB-Guide","Key Inclusion Criteria for Upfront Treatment Phase\n\n1. Sign and date the Main Trial informed consent form (ICF), prior to the start of any trial-specific procedures.\n2. Participant must be ≥18 years of age at the time the ICF is signed.\n3. Have pathologically documented breast cancer that:\n\n   * Is locally advanced and unresectable or metastatic (participants who can be treated with curative intent are not eligible).\n   * Participant must have histologically confirmed HER2+ and HR+ (ER+ and\u002For PR+), mBC. ER, PR, and HER2 measurements should be locally performed according to institutional guidelines.\n   * Is documented by local testing as HR-positive (either ER and\u002For PgR positive \\[ER or PgR ≥1%\\]) per ASCO\u002FCAP guidelines in the metastatic setting or from the primary tumor with the latest sample available.\n4. Has not received prior chemotherapy or HER2-targeted therapy for mBC. Participant who has received chemotherapy or HER2-targeted therapy or radiotherapy or surgery in the neoadjuvant or adjuvant setting are eligible, with a DFI of \\>6 months (\\>183 days) from completion of systemic chemotherapy or any HER2-targeted therapy (antibody, TKI or T-DM1) to diagnosis of advanced or metastatic disease.\n5. ECOG PS of 0 or 1 assessed no more than 3 days prior to initiation of trial intervention.\n6. Has at least 1 lesion, not previously irradiated, that can be measured accurately at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with CT or MRI, which is suitable for accurate repeated measurements, or nonmeasurable, bone-only disease that can be assessed by CT, MRI, or X-ray.\n7. Participant with brain metastases are allowed if participant is asymptomatic and does not require immediate local intervention.\n\nAdditional Key Criteria to Transition into the Maintenance Treatment Phase\n\n1\\. Participant transitioning into the Maintenance Treatment Phase must meet the following inclusion criteria for Maintenance Treatment:\n\n* Participant is without evidence of disease progression under T-DXd + pertuzumab treatment by local assessment according to RECIST v1.1 (ie, CR, PR, or SD), and\n* Participant is willing to switch therapy, and\n* Participant completed at least 8 cycles of T-DXd + pertuzumab and achieved cCR (confirmation of CR should be obtained during the next protocol defined scheduled tumor assessment.), or\n* Participant completed 18 cycles (in total) of T-DXd and achieved a SD or PR, and the last 2 scans showed no further tumor shrinkage (defined as 2 subsequent scans at least 6 weeks apart) or has an unconfirmed CR.\n\nAdditional Key Criteria for T-DXd Retreatment Phase\n\n1. Has received at least 1 dose of Maintenance Treatment.\n2. Has documented disease progression per RECIST v1.1 per investigator assessment during Maintenance Treatment.\n3. Participant who experienced ILD Grade 1 during the Maintenance Treatment Phase, must have fully resolved before starting T-DXd during the Retreatment Phase.\n\nKey Exclusion Criteria for Upfront Treatment Phase\n\n1. Has prior therapy with any CDK inhibitor.\n2. Previous T-DXd therapy for early BC with an EFS or disease-free interval of \\\u003C 12 months from completion of T-DXd therapy in the neoadjuvant or post-neoadjuvant setting.\n\nKey Exclusion Criteria for Maintenance Treatment Phase\n\n1. Is receiving concurrent therapy with other trial interventions (except pertuzumab which is part of Upfront Treatment and Maintenance Treatment).\n2. Has prior therapy with any CDK inhibitor.\n3. Has any unresolved SAE related to prior T-DXd + pertuzumab treatment from the Upfront Treatment Phase, defined as an event that has not resolved to baseline by the time of the eligibility assessment for the Maintenance Treatment Phase.\n4. Has experienced Grade 3 or 4 ILD\u002Fpneumonitis during the Upfront Treatment Phase.\n5. Has spinal cord compression or clinically active CNS metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n\nKey Exclusion Criteria for T-DXd Retreatment Phase\n\n1. Participant who developed ILD\u002Fpneumonitis Grade ≥2 during the Upfront Treatment Phase or Maintenance Treatment Phase.\n2. Participant has any unresolved SAE related to prior Maintenance Treatment Phase therapies defined as an event that has not resolved to baseline by the time of the eligibility assessment for the T-DXd Retreatment Phase.\n3. Participant who developed non-ILD toxicities related to T-DXd in the Upfront Treatment Phase that required T-DXd discontinuation.",{"count":388,"type":22},[61],"This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4\u002F6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+\u002FHR+ advanced\u002Fmetastatic breast cancer.",[29,96,435,436],"HER2 Positive","HR Positive",[29,96,438,439,440],"T-DXd","HER2 positive","HR positive","2026-07-22",{"date":443,"type":41},"2026-07-23",{"date":445,"type":22},"2026-09-04",{"date":447,"type":22},"2030-08-28",{"name":449,"class":116},"Daiichi Sankyo",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":181,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":458,"briefSummary":459,"conditions":460,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":138},"100640557","phase-2-a-phase-ii-study-of-ak146d1-combined-with-ak112-in-advanced-breast-cancer-100640557","NCT07591090","A Phase II Study of AK146D1 Combined With AK112 in Advanced Breast Cancer","A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Combined With AK112 in Patients With Advanced Breast Cancer","Inclusion Criteria:\n\n1. Be able to understand and voluntarily sign the written informed consent form.\n2. Aged of ≥ 18 years and ≤75 years.\n3. ECOG PS 0 or 1.\n4. The expected lifespan is ≥3 months.\n5. Patients with histologically confirmed locally advanced, recurrent, or metastatic breast cancer who are not eligible for curative surgical resection; and who have histologically or cytologically confirmed HER2-negative disease.\n6. At least one measurable lesion according to RECIST v1.1. Patients with only bone lesions or cutaneous lesions are not ineligible for enrollment.\n7. Have sufficient organ function.\n8. Females patients must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception.\n\nExclusion Criteria:\n\n1. Patients had breast cancer amenable to curative treatment at study enrollment.\n2. Concurrent other histopathological types confirmed by tumor histology or cytology.\n3. Having other active malignancies within 3 years.\n4. Currently participating in another interventional clinical study.\n5. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.\n6. Prior treatment with any therapy targeting Trop-2 or Nectin-4, or any chemotherapy agent targeting topoisomerase I.\n7. Receipt of systemic anti-tumor therapy (including chemotherapy, immunotherapy, biological agents, etc.) within 4 weeks prior to the first dose.\n8. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.\n9. Patients with clinically significant cardiovascular or cerebrovascular diseases or risks.\n10. Patients with active autoimmune diseases requiring systemic treatment within 2 years.\n11. Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.\n12. Known to be positive for HIV and other infections.\n13. Previous history of severe hypersensitivity reactions.\n14. Live attenuated vaccines were received within 4 weeks.\n15. Patients with a history of mental illness and incapacitated or limited capacity.\n16. Any disease or condition that, in the opinion of the investigator, would compromise patient safety or interfere with study assessments.",{"count":388,"type":22},[185],"This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 combined with AK112 in advanced breast cancer.",[29],"2026-07-21",{"date":441,"type":41},{"date":464,"type":41},"2026-07-17",{"date":466,"type":22},"2029-02-04",{"name":468,"class":116},"Akeso",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":492},"100633256","phase-1-study-of-rgt-490-in-patients-with-pik3ca-mutated-advanced-solid-tumors-100633256","NCT07524322","Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors","A Phase 1\u002F1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+\u002FHER2- Breast Cancers","Inclusion Criteria:\n\n* Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy.\n* Presence of one or more documented activating PIK3CA mutation in tumor tissue and\u002For blood.\n* At least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* An ECOG performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Diabetes mellitus requiring anti-hyperglycemic medication.\n* Prior treatment with PI3Kα inhibitors\n* Symptomatic, untreated, or uncontrolled central nervous system metastases.\n* Receipt of any local or systemic anticancer therapy or investigational anticancer agent within a protocol-defined washout period prior to study treatment.\n* Unresolved clinically significant toxicities from prior anticancer therapy\n* History of a another malignancy within 2 years prior to screening (exception adequately treated cancers).",{"count":477,"type":22},63,[92],"This is a phase 1\u002F1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer.\n\nParticipants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.",[213,481,482,369,370,29,483,371,484],"Ovarian Cancer","Endometrial Cancer","Unresectable Solid Tumor","Cervical Cancer",{"date":441,"type":41},{"date":487,"type":22},"2026-06",{"date":489,"type":22},"2028-10",{"name":491,"class":116},"Regor Pharmaceuticals Inc.",5,{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":23,"phases":502,"briefSummary":503,"conditions":504,"keywords":509,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":521},"100617452","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-08032562-in-people-with-advanced-or-metastatic-solid-tumors-100617452","NCT07318805","A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors","A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS","Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced or metastatic cancer of the breast or colon Part 1A: metastatic or advanced breast cancer or colorectal cancer for which no standard therapy is available Part 1B: metastatic or advanced breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and CDK4\u002F6 inhibitor in the advanced or metastatic setting Part 1C: metastatic or advanced colorectal cancer with at least having received chemotherapy and\u002For targeted therapy if appropriate Part 1D: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease Part 2A: metastatic or advanced breast cancer with disease progression after at least 1 prior line of CDK4\u002F6 inhibitor and at least 1 prior line of endocrine therapy Part 2B: metastatic or advanced colorectal cancer with at least having received chemotherapy and\u002For targeted therapy if appropriate Part 2C: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease\n* Measurable disease\n* ECOG performance status 0 or 1\n\nExclusion Criteria:\n\n* Active malignancy within 3 years prior to enrollment\n* Known symptomatic brain metastases requiring steroids\n* Advanced\u002Fmetastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term\n* Prior irradiation to \\>25% of the bone marrow\n* Hypertension that cannot be controlled by optimal medical therapy\n* Renal impairment\n* Hepatic dysfunction\n* Cardiac abnormalities\n* Active bleeding disorder\n* Active or history of clinically significant GI disease\n* Other unacceptable abnormalities as defined by protocol",{"count":501,"type":22},260,[92],"The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication.\n\nThis study is seeking participants that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC).\n\nAll participants in this study will take the study medication (PF-08032562) as pill by mouth. This will be repeated for 28-day cycles.\n\nDepending on which part of the study participants are enrolled into, they will receive the study medication PF-08032562 alone or in combination with other anti-cancer medications. The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by intramuscular (IM) injection into the muscle or intravenous (IV) infusion that is directly injected into the veins at different times (depending on the treatment) during the 28-day cycle. The study may also test different schedules.",[29,505,506,507,508],"Metastatic Breast Cancer (HR+\u002F HER2-)","Colorectal Cancer","Metastatic Colorectal Adenocarcinoma","Triple Negative Breast Cancer",[510,511,512,508,513],"Carcinoma, Breast","Estrogen Receptor Positive Breast Cancer","HER2- Breast Cancer","Colon Cancer",{"date":441,"type":41},{"date":516,"type":41},"2025-12-23",{"date":518,"type":22},"2030-04-14",{"name":520,"class":116},"Pfizer",13,{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":532,"phases":4,"briefSummary":533,"conditions":534,"keywords":535,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":138},"100645365","timing-of-ctdna-testing-in-advanced-breast-cancer-100645365","NCT07681323","Timing of ctDNA Testing in Advanced Breast Cancer","Timing of ctDNA Testing in Advanced Breast Cancer: Impact on Prognosis and Treatment Strategies - A Prospective Observational Study (TIMING)","TIMING","Inclusion Criteria:\n\n* Histologically confirmed advanced breast cancer\n* Age ≥18 years\n* Expected survival \\>3 months\n* Willing to undergo ctDNA testing and sign informed consent form\n\nExclusion Criteria:\n\n* The subject has not signed the informed consent form.\n* Pregnant or breastfeeding women.\n* Other situations deemed by the investigator as unsuitable for inclusion in the study.",{"count":531,"type":22},400,"OBSERVATIONAL","This multicenter, prospective observational cohort study aims to investigate the impact of circulating tumor DNA (ctDNA) level and key actionable gene mutation status on prognosis and treatment response in patients with advanced breast cancer.",[29],[536,537,538],"ctDNA","multigene testing","treatment strategy","2026-07-20",{"date":441,"type":41},{"date":542,"type":22},"2026-07-08",{"date":544,"type":22},"2029-06-30",{"name":546,"class":116},"Geneplus-Beijing Co. Ltd.",{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":181,"enrollmentInfo":554,"targetDuration":4,"studyType":23,"phases":556,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":138},"100549407","phase-2-study-of-adcs-combined-with-adebrelimab-in-her2-negative-advanced-breast-cancer-100549407","NCT06433609","Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer","A Phase II Study of Antibody-Drug Conjugates (ADCs) Combined With Adebrelimab in HER2-negative Advanced Breast Cancer","Inclusion Criteria:\n\n1. 18 years to 75 years old (including boundary values);\n2. ECOG PS Score: 0\\~1;\n3. Histologically or cytologically confirmed HER2-negative advanced breast cancer;\n4. Disease progression after prior ≥1 line of systemic therapy; if HR-positive, prior CDK4\u002F6 inhibitor is necessary;\n5. Based on RECIST v1.1, at least one measurable lesion;\n6. Brain metastasis with no clinical symptoms, or treated, stable brain metastases are eligible;\n7. Patients must have a life expectancy ≥ 6 months;\n8. Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);\n9. Women of childbearing potential should have a negative urine or serum pregnancy, and must promise to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy or be celibate; Men who are not surgically sterile (including those sterilized by methods other than bilateral orchiectomy \\[e.g., vasectomy\\]) and who intend to have sexual intercourse with female partners of childbearing potential must use a contraceptive method from enrollment, throughout the study, and for 6 months after the end of the study to prevent partner pregnancy;\n10. Available blood samples for ctDNA detection in the exploratory study;\n11. Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.\n\nExclusion Criteria:\n\n1. Has known active brain metastasis which needs local therapy immediately;\n2. Prior use of ADCs with the same target as study drugs;\n3. Existence of third space fluid that is not well controlled by effective methods, e.g. drainage;\n4. Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 4 weeks before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy;\n5. Use of other antitumor systemic treatment during the study;\n6. Has active autoimmune disease or a history of autoimmune disease;\n7. Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation;\n8. Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU\u002FmL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis;\n9. Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia \\>38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator);\n10. Receiving immunosuppressive medication, or systemic corticosteroid therapy for the purpose of immunosuppression (prednisone at \\>10mg\u002Fd or equivalent dose of other corticosteroids), and continuous use within 2 weeks before the first dose of study therapy;\n11. Other malignancy within prior 5 years unless curatively treated with no evidence of disease for at least recent 3 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma or skin squamous cell carcinoma;\n12. Hypersensitivity to study therapy or any of its excipients;\n13. Has known clinically significant lung disease, including but not limited to: interstitial lung disease, pneumonitis, pulmonary fibrosis;\n14. Known history of uncontrolled cardiovascular clinical symptom or disease that is not well controlled;\n15. Has received a live vaccine within 4 weeks before first dose of study therapy, or potential to receive a live vaccine during the trial treatment;\n16. Women with a positive serum or urine pregnancy test or who are breastfeeding; patients of childbearing potential who are unwilling or not available to use an effective method of contraception;\n17. Other conditions that might influence the study and analysis of results in the opinion of the investigator.",{"count":555,"type":22},113,[185],"Our study is aimed to evaluate the efficacy and safety of novel ADCs named SHR-A1811, SHR-A1921 and SHR-A2102 combined with adebrelimab in HER2-negative advanced breast cancer.",[29],"2026-07-13",{"date":561,"type":41},"2026-07-14",{"date":563,"type":41},"2024-08-05",{"date":565,"type":22},"2027-11",{"name":567,"class":48},"Beijing GoBroad Hospital",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":579,"conditions":580,"keywords":581,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":591,"locationsCount":138},"100639594","phase-4-real-world-study-of-pyrotinib-containing-regimens-of-advanced-her2-positive-breast-cancer-100639594","NCT07600164","Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer","Real-world Study of Pyrotinib-containing Regimens in First-line or Second-line Treatment of Advanced HER2-positive Breast Cancer","Inclusion Criteria:\n\n1. Aged ≥ 18 years old;\n2. Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer;\n3. Patients with first-line or second-line advanced disease:\n\n   First-line advanced disease: no prior systemic therapy for locally advanced or metastatic disease. For patients who received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy was more than 12 months; Second-line advanced disease: prior treatment with taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or recurrence occurring during neoadjuvant\u002Fadjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last neoadjuvant\u002Fadjuvant chemotherapy and HER2-targeted therapy;\n4. Planned to receive pyrotinib-containing regimen, and judged by investigators based on clinical practice to have potential subsequent treatment with Ruikang trastuzumab after failure of pyrotinib-containing therapy;\n5. Traceable medical records available throughout the treatment period.\n\nExclusion Criteria:\n\n1. Failure to sign the informed consent form;\n2. Pregnant or lactating females;\n3. Patients participating in any interventional clinical trial involving investigational drugs or marketed drugs at enrollment;\n4. Other conditions deemed ineligible for enrollment by the investigator's judgment.",{"count":576,"type":22},500,[578],"PHASE4","Given that pyrotinib has been proven to exert significant efficacy against HER2-positive advanced breast cancer in multiple Phase III studies, and the novel ADC drug disitamab vedotin has demonstrated potent anti-tumor activity, there remains insufficient real-world data on their sequential administration. This multicenter, prospective real-world study plans to enroll 500 patients with HER2-positive advanced breast cancer receiving first-line or second-line treatment. It aims to evaluate the efficacy and safety of sequential disitamab vedotin treatment after disease progression or intolerance to pyrotinib-based regimens (first-line: pyrotinib plus trastuzumab combined with chemotherapy; second-line: pyrotinib plus capecitabine). The primary endpoint is real-world second progression-free survival (rwPFS2), while secondary endpoints cover real-world progression-free survival (rwPFS), tumor response, overall survival (OS), time to treatment failure, safety profiles and patient-reported outcomes. It is currently expected to further validate the efficacy and safety of pyrotinib in patients with advanced HER2-positive breast cancer in the real-world setting, and to evaluate the efficacy and safety of recindopril trastuzumab following pyrotinib-containing regimens.",[188,29],[582,583,584,585],"HER2-positive breast cancer","Advanced breast cancer","pyrotinib","Trastuzumab Rezetecan","2026-07-10",{"date":559,"type":41},{"date":589,"type":41},"2026-07-06",{"date":420,"type":22},{"name":592,"class":48},"Peking University People's Hospital",{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":602,"briefSummary":603,"conditions":604,"keywords":606,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":618},"100592715","phase-1-a-phase-1-study-of-bms-986500-as-monotherapy-or-combination-therapy-in-advanced-solid-tumors-100592715","NCT06997029","A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors","A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4\u002F6 Inhibitor Pre-treated Advanced Breast Cancer","Inclusion Criteria:\n\n* Participants must be ≥ 18 years of age.\n* Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.\n* Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* For Part 2A only, participants must have CCNE1-amplified ovarian cancer\n\nExclusion Criteria:\n\n* Participants must not have an active brain metastasis.\n* Participants must not have impaired cardiac function or clinically significant cardiac disease.\n* Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.\n* Participants must not have Grade ≥ 2 peripheral neuropathy.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":601,"type":22},234,[92],"The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4\u002F6 inhibitor pre-treated advanced breast cancer.",[95,29,605],"Advanced Ovarian Cancer",[607,608,609],"cancer","oncology","solid tumor","2026-07-09",{"date":586,"type":41},{"date":613,"type":41},"2025-08-01",{"date":615,"type":22},"2028-12-14",{"name":617,"class":116},"Bristol-Myers Squibb",21,{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":627,"enrollmentInfo":628,"targetDuration":4,"studyType":532,"phases":4,"briefSummary":630,"conditions":631,"keywords":4,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":632,"startDateStruct":633,"completionDateStruct":634,"leadSponsor":636,"locationsCount":4},"100645729","shield-surveillance-of-hrher2---implementing-esr1m-long-term-monitoring-and-detection-in-1l-abc-100645729","NCT07701070","SHIELD: Surveillance of HR+\u002FHER2- : Implementing ESR1m Long-term Monitoring and Detection in 1L aBC","A Multicenter Study to Describe the Frequency and Emergence of ESR1 Mutations in Patients With Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer Receiving First-Line Endocrine Based Therapy","SHIELD","Inclusion Criteria:\n\n* Age 18 years or older at the time of informed consent and willing and able to provide informed consent before any study-related procedures.\n* Histologically- or cytologically-confirmed hormone receptor-positive (ER- and\u002For progesterone receptor-positive), human epidermal growth factor receptor 2-negative (HER2-negative) advanced breast cancer.\n* Receiving first-line therapy with an aromatase inhibitor in combination with a CDK4\u002F6 inhibitor for at least 6 months and no more than 18 months, with no evidence of disease progression at study entry, as assessed by the investigator.\n* Able and willing to provide a blood sample for circulating tumour DNA testing for ESR1 mutation assessment at approximately quarterly intervals.\n\nExclusion Criteria:\n\n* Evidence of disease progression during first-line aromatase inhibitor plus CDK4\u002F6 inhibitor therapy, based on investigator assessment.\n* Known ESR1 mutation status at study entry.","130 Years",{"count":629,"type":22},3000,"This is a multicountry, multicenter, observational study in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer receiving first-line endocrine-based therapy with an aromatase inhibitor in combination with a CDK4\u002F6 inhibitor. The study aims to describe the prevalence of ESR1 mutations at baseline and the emergence of ESR1 mutations over time using circulating tumor DNA testing in routine clinical practice.\n\nPatients receiving first-line treatment for at least 6 months and no more than 18 months, without evidence of disease progression at study entry, may undergo baseline ESR1 mutation testing. Patients with a negative baseline result may undergo longitudinal monitoring approximately every 3 months, for up to 18 months or 6 testing timepoints, to assess emergence of ESR1 mutations. The study will also describe mutation subtypes, testing methods used in routine practice, selected clinical characteristics, and treatment patterns across participating countries.",[29],{"date":561,"type":41},{"date":194,"type":22},{"date":635,"type":22},"2029-03-30",{"name":272,"class":116},{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":23,"phases":646,"briefSummary":647,"conditions":648,"keywords":649,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":653,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":138},"100639632","phase-2-trastuzumab-deruxtecan-and-lovastatin-in-her2-low-and-ultralow-advanced-or-metastatic-breast-cancer-100639632","NCT07619365","Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer","Phase II Trial Evaluating Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer (MBC)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed HER2 low (IHC 1+ or 2+ with negative in-situ hybridization) or ultralow (IHC 0 with incomplete\u002Ffaint membrane staining in \\>0 but ≤10% of tumor cells) breast cancer. Patients may be advanced\u002Funresectable or metastatic.\n* Patients must have received no more than 1 prior line of chemotherapy (e.g. capecitabine). There is no limit on the prior number of endocrine-based therapies for patients with hormone-receptor positivity.\n* Measurable disease per RECIST 1.1.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n* The effects of T-DXd and lovastatin on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 7 months after the last dose of either study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform her treating physician immediately.\n* Patients must have left ventricular ejection fraction (LVEF) of ≥50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before C1D-1.\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Prior treatment with T-DXd or other topoisomerase I ADC including sacituzumab govitecan, datopotamab deruxtecan, or investigational ADCs with topoisomerase I payloads.\n* Prior statin use within 7 days prior to C1D-1.\n* Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤1 or baseline. Participants with chronic grade 2 toxicities may be eligible per the discretion of the Investigator after consultation with the Study PI or designee (e.g., grade 2 chemotherapy-induced neuropathy).\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial\n* Currently receiving any other investigational agents, or receipt of any investigational agents within 3 weeks or 5 half-lives, whichever is shorter, prior to C1D-1.\n* Receipt of chemotherapy, immunotherapy, endocrine therapy, or other systemic anticancer therapy within 3 weeks or 5 half-lives, whichever is shorter, prior to C1D-1.\n* Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression, and patients are not taking steroids to control edema or other symptoms.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to T-DXd, lovastatin, or other agents used in the study.\n* Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (i.e. Rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy.\n* Patients with a history of non-infectious ILD\u002Fpneumonitis that required steroids or has current ILD\u002Fpneumonitis. Patients with a history of infectious ILD\u002Fpneumonitis should be discussed with the study PI.\n* Prior intolerance to statin therapy, defined as intolerable muscle symptoms or significant transaminitis elevation (\\>3x ULN) or CK elevation (\\>5x ULN) attributed to statin therapy within the last 2 years prior to C1D-1.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or clinically significant cardiac arrhythmia.\n* History or current significant cardiovascular disease, stroke, severe dyslipidemia, or vascular disorders that require continuous statin dosing. Uncertain cases should be discussed with the study PI for clarification of eligibility.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of C1D1.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.\n* Use of strong inhibitors of CYP3A4 within 5 half-lives of the medication prior to C1D-1.",{"count":645,"type":22},60,[185],"The purpose of this study is to evaluate use of lovastatin, a drug that may lower CAV-1 levels, in order to increase HER2 expression on cells and enhance the uptake and efficacy of trastuzumab deruxtecan (T-DXd) in HER2-low and ultralow advanced metastatic breast cancer. Trastuzumab deruxtecan (T-DXd) is an FDA approved antibody drug conjugate for HER2-low and ultralow breast cancer and lovastatin is a cholesterol lowering agent.",[213,29,96],[650,651,652],"Antibody drug conjugate","HER2 low","HER2 ultralow",{"date":542,"type":41},{"date":655,"type":22},"2026-08-31",{"date":657,"type":22},"2031-08-31",{"name":659,"class":48},"Washington University School of Medicine"]