[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-breast-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,170,0,25,[9,42,80,107,141,169,207,230,252,274,296,316,337,362,385,415,434,460,485,513,540,560,592,619,640],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100608578","phase-2-nurturing-exercise-routine-for-greater-improvement-in-zest-and-energy-on-enhertu-100608578",false,"NCT07203378","Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu","ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study","ENERGIZE","Inclusion Criteria:\n\n* Subject aged ≥ 18 years\n* Diagnosis of locally advanced\u002Funresectable or metastatic breast cancer. Note: Patients with High-Risk HER-2 + breast cancer after completion of neoadjuvant chemotherapy requiring adjuvant Enhertu are allowed at the discretion of the treating physician.\n* Has received 3 or 4 cycles of Enhertu and is expected to continue treatment for at least 12 weeks. Note: HER-2 targeted systemic therapy (e.g. Trastuzumab and\u002For Pertuzumab) in conjunction with Enhertu is allowed.\n* Able and willing to participate in the interventional aerobic exercise and resistance exercises.\n* Currently following standard of care contraception requirements and willing to continue following these requirements for the duration of therapy.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Experiencing clinical fatigue symptoms in the opinion of the investigator.\n* Subject has completed the ACSM exercise preparticipation health screening and is, in the opinion of the investigator, fit to participate in this study.\n\nExclusion Criteria:\n\n-Currently adhering to national physical activity guidelines for resistance training, as defined as participating in structured resistance training ≥ two days per week.\n\n* Structured is defined as time set aside in the subject's day to workout.\n* Resistance training is defined as exercises which use weights, bands, or body weight (e.g., squats or push-ups).\n\nAND Currently participating in structured moderate-intensity aerobic exercise for ≥ 150 minutes per week.\n\n* Moderate-intensity exercise is defined as activities where the subject can talk but not sing.\n* Aerobic exercise includes, but is not limited to, walking, swimming, cycling, running, rowing, hiking, and elliptical.\n\n  * Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.\n  * Participants taking prohibited medications as described in Section 7.4.1.","ALL","18 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this study is to test the efficacy of using a 12-week, home-based, unsupervised aerobic and resistance training exercise program for changes in cancer-related fatigue in patients with metastatic breast cancer who are receiving Enhertu.",[28],"Metastatic Breast Cancer","RECRUITING","2026-08-18",{"date":32,"type":33},"2026-08-20","ACTUAL",{"date":35,"type":33},"2025-11-04",{"date":37,"type":22},"2028-11",{"name":39,"class":40},"University of Utah","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":63,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":76,"locationsCount":79},"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":50,"type":22},399,[52],"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.",[55,56,28,57,58,59,60,61,62],"Advanced Solid Tumor","Advanced Breast Cancer","Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Malignant Neoplasm of Breast","HER2-negative Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer","Non-small Cell Lung Cancer",[64,65,66,67,68,61,69,70],"breast cancer","advanced solid tumor","advanced breast cancer","hormone receptor positive breast cancer","HER2-negative breast cancer","BGB-43395","non-small cell lung cancer",{"date":72,"type":33},"2026-08-19",{"date":74,"type":33},"2023-12-01",{"date":37,"type":22},{"name":77,"class":78},"BeOne Medicines","INDUSTRY",62,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100511921","destiny-breast-respond-her2-ultralow-europe-100511921","NCT05945732","DESTINY Breast Respond HER2-(Ultra)Low Europe","A Prospective, Non-interventional Study (NIS) With Trastuzumab Deruxtecan For Patients With HER2-(Ultra)Low Expressing Unresectable and\u002For Metastatic Breast Cancer Accompanied By a Disease Registry of Patients Treated With Conventional Chemotherapy (DESTINY Breast Respond HER2-(Ultra)Low Europe)","Inclusion Criteria:\n\nStudy Group 1 and Study Group 2\n\n* Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and\u002For mBC\n* Decision to newly initiate therapy of T-DXd or conventional chemotherapy according to the physicians choice per SmPC\n* Written and signed Informed Consent to participate in the study\n\nStudy Group 1\n\n* Documented HER2-low status (IHC1+, IHC2+\u002FISH-)\n* Patients who have received prior chemotherapy in the metastatic setting or\n* Patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy\n\nStudy Group 2:\n\n* Documented HR+ status\n* Documented HER2-low status (IHC1+ or IHC2+\u002FISH-) or HER2-ultralow (defined as IHC 0 with membrane staining \\[IHC \\> 0 to \\\u003C1+\\]) status\n* Patients who have received at least one endocrine therapy in the metastatic setting\n* Patients who have NOT received prior chemotherapy in the metastatic setting\n\nExclusion Criteria:\n\nStudy Group 1 and Study Group 2\n\n* Pregnancy or breastfeeding\n* Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.\n\nNo other specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.",{"count":88,"type":22},2295,"OBSERVATIONAL","Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.\n\nBased on the extended therapeutic indication of Trastuzumab deruxtecan (Enhertu®), a new patient population will be enrolled, comprising adult patients with unresectable or metastatic HR-positive, HER2-low, or HER2-(ultra)low breast cancer who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of treatment.",[92,28,93,94],"Unresectable Breast Cancer","HER2-low Expressing Breast Cancer","HER2-(Ultra)Low Expressing Breast Cancer",[92,28,93,96,97,98],"Trastuzumab Deruxtecan","Enhertu®","HER2-(ultra)low Expressing Breast Cancer",{"date":72,"type":33},{"date":101,"type":33},"2023-10-24",{"date":103,"type":22},"2030-12-31",{"name":105,"class":78},"Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company",216,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":119,"conditions":120,"keywords":125,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100521670","phase-3-study-of-the-bria-imt-regimen-and-cpi-vs-physicians-choice-in-advanced-metastatic-breast-cancer-100521670","NCT06072612","Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.","Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.","BRIA-ABC","Inclusion Criteria:\n\n1. Be ≥ 18 years of age.\n2. Have signed informed consent.\n3. Have histological confirmation of breast cancer with either locally recurrent unresectable and\u002For metastatic lesions, and have failed prior therapy:\n\n   * Patients with persistent disease and local recurrence must not be amenable to local treatment.\n   * For patients with metastatic disease, late-stage MBC with no meaningful alternative therapies available and the following class specific treatment histories:\n\n     1. Human epidermal growth factor 2 (HER2) positive must be previously treated with at least 3 regimens containing at least two anti-HER2 and at least one chemotherapy containing regimen.\n     2. Estrogen receptor (ER), progesterone receptor (PR) positive tumors: must be refractory to hormonal therapy demonstrated by progression on at least 2 hormonal agents in 2 separate lines of hormone directed therapy.\n     3. Triple Negative tumors: Must have exhausted all curative intent therapies including at least 2 prior chemotherapy regimens, which can include regimens in neoadjuvant and adjuvant settings.\n     4. Cancers with known germline or genomic actionable targets, e.g. g\u002FmBRCA, must have been treated with all tumor directed indicated treatment e.g. PARPi, if tolerated.\n     5. HER2 low patients, in addition to the appropriate therapies based on ER\u002FPR status and germline or genomic actionable targets, must also have received at least one HER2-targeted agent approved for treatment of HER2 low patients.\n     6. HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens.\n     7. Patients with new or progressive breast cancer metastatic to the brain will be eligible provided:\n\n        * The brain metastases must be clinically stable (without evidence of progressive disease by imaging for at least 4 weeks prior to first dose)\n        * There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose\n        * Tumor is not impinging on Middle Cerebral Artery\u002Fspeech-motor strip\n        * If surgically debulked, must be healed with at least 3 weeks since surgery prior to the first dose\n4. Has expected survival of at least 4 months.\n5. ECOG performance status of 0, 1 or 2\n\nExclusion Criteria:\n\n1. Concurrent or recent chemotherapy, immunotherapy or major surgery within 21 days prior to the first dose.\n2. Radiotherapy within 14 days of the first dose of study treatment.\n3. Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support).\n4. Any toxicity to prior CPI that was grade 3 or higher unless it has been successfully treated (e.g. hypothyroidism or hypopituitarism treated with replacement therapy), .\n5. Toxicity to prior CPI that has not resolved to grade 1 or less except for stable asymptomatic endocrinopathies.\n6. History of clinical hypersensitivity to the designated therapy as specified in the protocol, including the proposed TPC, beef, or to any components used in the preparation of SV- BR-1-GM.\n7. History of hypersensitivity to any of the therapies proposed for treatment in this study.\n8. Serum creatinine OR Measured OR calculated Creatinine Clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) \\>2.0 × ULN or \\\u003C30 mL\u002Fmin for participants with creatinine levels \\>2.0 × institutional ULN.\n9. Absolute granulocyte count \\\u003C1000; platelets \\\u003C80,000; hemoglobin ≤ 7 g\u002FL.\n10. Bilirubin ≥ 2 × ULN unless conjugated bilirubin ≤ ULN; alkaline phosphatase \\>5x upper limit of normal (ULN); ALT\u002FAST \\>3x ULN. For patients with hepatic metastases, ALT\u002FAST \\>5x ULN is exclusionary.\n11. INR or PT or aPTT \\> 1.8 × ULN, unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.\n12. Receiving any medication listed in the prohibited medication section of the protocol.\n13. Proteinuria \\>2+ on urinalysis\n14. A history or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. Screening corrected QT interval (QTc) interval \\>480 milliseconds is excluded (corrected by Fridericia or Bazett formula). In the event that a single QTc is \\>480 milliseconds, the participant may enroll if the average QTc for the 3 ECGs is \\\u003C480 milliseconds.\n15. New York Heart Association stage 3 or 4 cardiac disease.\n16. A pericardial effusion of moderate severity or worse.\n17. Symptomatic pleural effusion or ascites. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.\n18. Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she agrees to take appropriate precautions to avoid becoming pregnant during the study and has a negative serum pregnancy test within 7 days prior to starting treatment.\n19. Men must have been sterile or, if they were potentially fertile\u002Freproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.\n20. Women who are pregnant or nursing.\n21. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for \\> 1 year, after treatment with curative intent.\n22. Patients who have uncontrolled HIV or have clinical or laboratory features indicative of AIDS.\n23. Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.\n24. Have an active autoimmune disease that has required systemic treatment in past year (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.\n25. Known active HAV, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization).\n26. Active infections requiring systemic therapy within the past 14 days.\n27. Patients with severe psychiatric disease (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator in consultation with the Medical Monitor.\n28. Has received a live vaccine within 28 days of the first dose of study drug.\n29. Patients may not be on a concurrent clinical trial, unless approved by the Investigator.",{"count":116,"type":22},404,[118],"PHASE3","This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor \\[Retifanlimab\\], versus Treatment of Patients'\u002FPhysicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.",[121,28,122,123,124],"Breast Cancer","Breast Neoplasm","Breast Cancer Metastatic","End Stage Cancer",[126,127,128,129,130],"Breast","metastatic","advanced","cancer","late line","2026-08-14",{"date":133,"type":33},"2026-08-17",{"date":135,"type":33},"2023-12-05",{"date":137,"type":22},"2028-06",{"name":139,"class":78},"BriaCell Therapeutics Corporation",79,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":149,"minAge":19,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100633297","phase-1-a-study-of-hld-0117-in-patients-with-metastatic-breast-cancer-100633297","NCT07524855","A Study of HLD-0117 in Patients With Metastatic Breast Cancer","A Phase 1a\u002F1b Study of HLD-0117 in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC)","HLD-0117","Inclusion Criteria:\n\n* Female (assigned at birth), ≥18 years old, and able to provide informed consent\n* Histologically confirmed metastatic or locally advanced breast cancer\n* Postmenopausal status defined by surgical or natural menopause, or ovarian suppression with a GnRH agonist\n* Prior treatment including at least one endocrine therapy in the metastatic setting, at least one CDK4\u002F6 inhibitor (in the adjuvant and\u002For metastatic setting), and no more than two prior cytotoxic regimens in the metastatic setting\n* Radiologic disease progression on the most recent therapy\n* Measurable disease per RECIST v1.1\n* Willingness to provide baseline and on-treatment tumor biopsies, unless not feasible or medically appropriate\n* ER-positive and HER2-negative status documented within 2 years\n* ECOG performance status 0-1 and life expectancy of at least 3 months\n* Adequate organ function Recovery from prior therapy-related toxicities to Grade ≤1 (except alopecia; neuropathy and endocrinopathies ≤Grade 2)\n* Ability to swallow oral medication and comply with study procedures\n* Stable dose (≥30 days) of bisphosphonates or denosumab, if applicable\n\nExclusion Criteria:\n\n* Inflammatory breast cancer or known brain metastases\n* Recent major bleeding or uncontrolled bleeding disorder\n* Ongoing corticosteroid use \\>10 mg\u002Fday (prednisone equivalent)\n* Recent anticancer or investigational therapy within 14 days (28 days for fulvestrant)\n* Untreated or unstable spinal cord compression\n* Significant cardiovascular disease within 6 months or ongoing uncontrolled cardiac conditions\n* Active or uncontrolled infection (controlled HIV or treated hepatitis C allowed)\n* Uncontrolled renal, pancreatic, or liver disease (excluding stable conditions such as Gilbert's syndrome or liver metastases)\n* Another malignancy requiring treatment within 2 years (except low-risk, curatively treated cancers)\n* Major surgery within 28 days\n* Any condition that may interfere with safety or study compliance\n* Pregnancy or breastfeeding","FEMALE",{"count":5,"type":22},[52],"Assessment of the safety and efficacy of HLD-0117 as monotherapy in patients with estrogen receptor positive (ER+) metastatic breast cancer (MBC) or locally advanced breast cancer that have progressed on prior systemic therapies.",[28],[64,155,156,157,158,159],"RIPTAC","breast carcinoma","locally advanced breast cancer","breast tumor","malignant Tumor of the breast","2026-08-13",{"date":133,"type":33},{"date":163,"type":33},"2026-04-09",{"date":165,"type":22},"2029-10-10",{"name":167,"class":78},"Janssen Research & Development, LLC",6,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":180,"conditions":181,"keywords":185,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100599536","phase-3-palazestrant-in-combination-with-ribociclib-for-the-first-line-treatment-of-erher2--advanced-breast-cancer-100599536","NCT07085767","Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+\u002FHER2- Advanced Breast Cancer","A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)","OPERA-02","Inclusion Criteria:\n\n* Adult female or male participants.\n* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.\n* Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).\n* De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4\u002F6 inhibitors)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal functions.\n* Female participants can be pre-, peri- or postmenopausal.\n* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.\n\nExclusion Criteria:\n\n* Disease recurrence during adjuvant endocrine therapy\n* Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.\n* Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.\n* History of allergic reactions to study treatment.\n* Any contraindications to letrozole and ribociclib.\n* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.",{"count":178,"type":22},1000,[118],"This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.",[121,182,28,183,184],"Locally Advanced Breast Cancer","ER Positive Breast Cancer","HER2 Negative Breast Carcinoma",[186,187,188,189,190,191,192,193,194,195,196,197,198],"Randomized","Multicenter","Double-Blind","Active-Controlled","Phase 3","Palazestrant","Complete Estrogen Receptor Antagonist (CERAN)","Selective Estrogen Receptor Degrader (SERD)","Ribociclib","CDK4\u002F6i","Letrozole","Aromatase inhibitors","Antineoplastic agents",{"date":133,"type":33},{"date":201,"type":33},"2025-11-03",{"date":203,"type":22},"2032-01",{"name":205,"class":78},"Olema Pharmaceuticals, Inc.",181,{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100318305","phase-1-a-study-evaluating-the-efficacy-and-safety-of-multiple-treatment-combinations-in-patients-with-metastatic-or-locally-advanced-breast-cancer-100318305","NCT03424005","A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer","A Phase Ib\u002FII, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)","Morpheus-panBC","Inclusion Criteria\n\nPatients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort):\n\n* Age \\>\u002F= 18 years at the time of signing Informed Consent Form\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n* Able to comply with the study protocol, in the investigator's judgment\n* Metastatic or inoperable locally advanced adenocarcinoma of the breast\n* Measurable disease (at least one target lesion) according to RECIST v1.1\n* Life expectancy \\>\u002F= 3 months, as determined by the investigator\n* Tumor accessible for biopsy, unless archival tissue is available\n* Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing\n* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from breastfeeding and donating eggs, as outlined for each specific treatment arm\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm\n\nExclusion Criteria\n\nExclusion Criteria for Stage 1\n\n* Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds\n* Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment, or other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study\n* Eligibility only for the control arm\n\nExclusion Criteria for Stage 1 (both cohorts) and Stage 2 (2L CIT-naïve cohort)\n\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade \\\u003C\u002F= 1 or better with the exception of alopecia of any grade and Grade \\\u003C\u002F= 2 peripheral neuropathy\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n* Uncontrolled tumor-related pain\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* History of leptomeningeal disease\n* Active or history of autoimmune disease or immune deficiency\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Severe infection within 4 weeks prior to initiation of study treatment\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment\n* Significant cardiovascular disease\n* Prior allogeneic stem cell or solid organ transplantation\n* History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study",{"count":216,"type":22},1132,[52,25],"This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.\n\nThe study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study:\n\nCohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \\[1L\\] PD-L1+ cohort).\n\nCohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \\[2L\\] CIT-naïve cohort).\n\nCohort 3, 5, 6 and 7 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations.\n\nCohort 4 will consist of participants with locally advanced or metastatic HER2+ \u002FHER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ \u002FHER2-low cohort).\n\nIn each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.",[28],"2026-08-11",{"date":222,"type":33},"2026-08-12",{"date":224,"type":33},"2018-03-30",{"date":226,"type":22},"2030-09-30",{"name":228,"class":78},"Hoffmann-La Roche",49,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":149,"minAge":19,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":243,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":41},"100606765","group-based-comprehensive-lifestyle-program-for-women-with-metastatic-breast-cancer-100606765","NCT07179809","Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer","Pilot Randomized Trial of a Virtual, Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer: Exploring Dose of Support to Optimize Adherence","Inclusion Criteria:\n\n1. Patients with HR+\u002FHER2 negative MBC\n2. On first- or second-line treatment\n3. Life expectancy at least 12 months\n4. Only females\n5. Age 18 years or older\n6. Able to read, write, and speak English\n7. Willingness to follow protocol requirements\n8. Have a smartphone with access to cellular service or computer access with internet service\n9. Oriented to person, place, and time\n10. Consume less than 3 servings of fruit and vegetable\u002Fday\n11. Engage in less than 150 minutes moderate\u002Fvigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling)\n12. Engage in a mind-body practice less than 4 times a month\n\nExclusion Criteria:\n\n1. Another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers)\n2. Any major thought disorder (e.g., schizophrenia, dementia)\n3. Communication barriers (e.g., hard of hearing)\n4. Poorly-controlled or uncontrolled diabetes in the opinion of the physician(s)\n5. Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)",{"count":238,"type":22},100,[240],"NA","The research study is to learn how the ACLP can best support patients with stable HR+\u002FHER2- MBC.",[28],"NOT_YET_RECRUITING","2026-08-10",{"date":222,"type":33},{"date":247,"type":22},"2026-12-28",{"date":249,"type":22},"2029-10-01",{"name":251,"class":40},"M.D. Anderson Cancer Center",{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":41},"100556489","phase-2-adaptive-therapy-with-capecitabine-for-treatment-of-metastatic-er-positive-her2-negative-breast-cancer-100556489","NCT06525766","Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer","Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer","Inclusion Criteria:\n\n* PRE-REGISTRATION: Provide written informed consent Note: Pre-registration should occur prior to screening research blood draws being completed\n* PRE-REGISTRATION: Provider anticipates the patient will begin on capecitabine within 14 days or has started capecitabine within the past 42 days and has had a maximum of two cycles Note: Pre-registration should occur prior to screening research blood draws being completed\n\nREGISTRATION - INCLUSION CRITERIA\n\n* Age ≥ 18 years\n* Histological confirmation of estrogen-receptor positive (ER+), HER2-negative overexpression or amplification negative as per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines, metastatic breast cancer\n* Measurable disease. Bone only disease allowed if associated with soft tissue component that is measurable by Response Evaluation Criteria is Solid Tumors (RECIST) 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 14 days prior to registration), no transfusions allowed ≤ 14 days prior to registration\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 14 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 14 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)\n* Calculated creatinine clearance ≥ 30 ml\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)\n* Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to provide mandatory blood specimens for correlative research\n* Ability to undergo re-staging CT scans as required by the protocol\n\n  * Note: for patients who have had up to two cycles of capecitabine prior to joining the study, they must have had their initial CT imaging completed within 28 days of their first dose of capecitabine\n* Willing to return to enrolling institution at the specified frequency for follow-up (during the active monitoring phase of the study)\n* Cohort 2 only: Stable disease, partial or complete response on imaging after beginning capecitabine\n\nExclusion Criteria:\n\n* Prior chemotherapy or use of antibody drug conjugate in the metastatic setting\n\n  * Note - Cohort 2 only: Patients can have had up to two cycles of capecitabine before joining the study\n* Any of the following, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* Any of the following prior therapies:\n\n  * Major surgery ≤ 3 weeks prior to registration\n  * Radiation therapy ≤ 2 weeks prior to registration\n* Evidence of visceral crisis or impending cord compression\n* Evidence of uncontrolled brain metastasis requiring whole brain irradiation or intervention\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * ongoing or active infection\n  * symptomatic congestive heart failure\n  * unstable angina pectoris\n  * uncontrolled cardiac arrhythmia\n  * chronic oxygen dependence\n  * respiratory failure\n  * or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy ≤ 3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n* If there is a history of prior malignancy, they must not be receiving other cancer specific treatment. Except for antiestrogen treatment (aromatase inhibitors or selective estrogen modulators) for their cancer are permitted if they meet other eligibility criteria. Denosumab and zoledronic acid, are permitted as established adjunct therapies per guidelines\n* History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Patients known to have certain homozygous or compound heterozygous dihydropyrimidine dehydrogenase (DPYD) variants that result in complete absence of deoxypyridinoline (DPD) activity. Test results do not need to be available prior to registration\n* History of severe hypersensitivity reactions to fluorouracil or capecitabine",{"count":260,"type":22},35,[25],"This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 negative breast cancer.",[264,265,266,28],"Anatomic Stage IV Breast Cancer AJCC v8","Estrogen-receptor-positive Breast Cancer","Metastatic HER2-Negative Breast Carcinoma",{"date":222,"type":33},{"date":269,"type":33},"2025-10-01",{"date":271,"type":22},"2030-10-15",{"name":273,"class":40},"Mayo Clinic",{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":295},"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":283,"type":22},75,[25],"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.",[121,28,56,57,287],"Human Epidermal Growth Factor 2 Low Breast Cancer",{"date":222,"type":33},{"date":290,"type":33},"2024-06-17",{"date":292,"type":22},"2028-12",{"name":294,"class":40},"Reshma L. Mahtani, D.O.",3,{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":315},"100619667","a-study-to-evaluate-the-effectiveness-and-safety-of-inavolisib-in-participants-with-endocrine-resistant-pik3ca-mutated-hormone-receptor-positive-her2-negative-locally-advanced-or-metastatic-breast-cancer-100619667","NCT07347600","A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer","A Non-interventional Study to Evaluate the Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (reaINAVO)","reaINAVO","Inclusion Criteria:\n\n* Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+\u002FHER2- LA\u002FmBC, following recurrence on or after completing adjuvant endocrine therapy\n* Participants must receive the treatment of inavolisib for the first time\n* PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay \\[Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)\\] by testing of blood or tumor tissue prior to the initiation of inavolisib\n\nExclusion Criteria:\n\n* Participants for which the treatment with inavolisib is not indicated per prescribing information. If the participant starts palbociclib and fulvestrant first, and starts inavolisib after getting a PIK3CA mutation-positive test result later, the palbociclib and fulvestrant will not be deemed as a different line of therapy. However, the medical order of PIK3CA mutation test must be made before or at the same time with the prescription of palbociclib and fulvestrant\n* Participants not receiving treatment for LA\u002FmBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)\u002Flocal labeling\n* At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study",{"count":305,"type":22},500,"The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA\u002FmBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.",[182,28],"2026-08-07",{"date":220,"type":33},{"date":311,"type":33},"2026-01-21",{"date":313,"type":22},"2029-09-09",{"name":228,"class":78},29,{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":323,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":243,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":41},"100651153","phase-2-a-phase-ii-study-of-ssgj-612-plus-a-her2-targeted-adc-in-hr-positive-her2-low-or-her2-ultralow-expression-metastatic-breast-cancer-100651153","NCT07757230","A Phase II Study of SSGJ-612 Plus a HER2-Targeted ADC in HR-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer","A Phase II Clinical Study of SSGJ-612 in Combination With a Human Epidermal Growth Factor Receptor 2 (HER2)-Targeted Antibody-Drug Conjugate (ADC) in Patients With Hormone Receptor (HR)-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer","Inclusion Criteria:\n\n* Voluntary participation in this study, signed informed consent form, good treatment compliance, and willingness to cooperate to complete all trial procedures.\n* Expected survival duration ≥ 3 months.\n* Histopathologically confirmed breast cancer meeting all of the following criteria simultaneously:\n\n  1. Metastatic tumor;\n  2. Tumor samples tested by central laboratory confirmed as HER2-low or HER2 ultra-low expression;\n  3. No prior test results reporting HER2 positivity;\n  4. Tumor sample testing confirms hormone receptor-positive (HR+) status.\n* Patients must satisfy either of the following conditions:\n\n  1. Disease progression within 6 months after initiation of first-line endocrine therapy combined with cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitors for metastatic disease;\n  2. Received at least 2 lines of prior endocrine therapy for metastatic disease, with disease progression post-treatment.\n* Participants in Part 1: Breast cancer patients who have received at least one line of chemotherapy for metastatic disease; Participants in Part 2: Breast cancer patients who have not received any chemotherapy for metastatic disease.\n* At least one repeatedly and accurately measurable tumor lesion as target lesion assessed per RECIST v1.1 criteria.\n\nExclusion Criteria:\n\n* Uncontrolled or severe cardiovascular disease.\n* History of interstitial lung disease (ILD)\u002Fpneumonia requiring corticosteroid therapy (non-infectious), or current ILD\u002Fpneumonia, or suspected ILD\u002Fpneumonia not excluded by screening imaging.\n* Presence of pulmonary-specific, clinically significant comorbid conditions.\n* Presence of spinal cord compression, or clinically active central nervous system metastases.\n* Female patients who are pregnant, breastfeeding, or planning pregnancy.\n* Patients who received investigational drug therapy in another clinical trial within 30 days prior to first study drug administration, or who are concurrently enrolled in another clinical trial. Note: Exclusions include participation in observational (non-interventional) clinical trials, or being in the follow-up phase of an interventional clinical trial.\n* Presence of drug abuse, or other diseases (e.g., psychiatric disorders) that, in the investigator's judgment, may interfere with patient participation in the trial or affect the assessment of trial outcomes.","75 Years",{"count":325,"type":22},87,[25],"This study is a phase II clinical trial of SSGJ-612 combined with a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or HER2-ultralow metastatic breast cancer.",[28],"2026-08-06",{"date":220,"type":33},{"date":332,"type":22},"2026-09",{"date":334,"type":22},"2029-07",{"name":336,"class":78},"Shenyang Sunshine Pharmaceutical Co., LTD.",{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":361},"100541015","phase-1-beamion-bcgc-1-a-study-to-find-a-suitable-dose-of-zongertinib-used-alone-and-in-combination-with-other-treatments-to-test-whether-it-helps-people-with-different-types-of-her2-cancer-that-has-spread-100541015","NCT06324357","Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread","Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)","Inclusion criteria:\n\n* Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF)\n* Cohorts A to K and Cohort O: Documented Human epidermal growth factor receptor 2 overexpressing and\u002For amplified (HER2+), metastatic breast cancer (mBC) or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma (mGEAC).\n* Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression\u002Famplification according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) gastric cancer guidelines and according to the result of local testing.\n* For dose optimization and justification (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival tissue\n* History of prior treatment lines in palliative setting:\n\n  * For cohorts A, B, C, D, E, F, G, H, I, I-ext, J, J-ext, K and O documented investigator assessed progression after HER2-directed treatment for unresectable locally advanced or metastatic disease (For Cohorts D, H, I (I-ext), J (J-ext) - patients must have been pretreated with trastuzumab deruxtecan (T-DXd) and have progressed or have been intolerant to previous T-DXd).\n  * For cohorts L, L-ext, M and N documented progression or recurrence of disease during or following their latest line of therapy. Patients must have had at least one prior line of therapy for locally advanced unresectable disease or metastatic disease (adjuvant and neoadjuvant therapy excluded) and documented disease progression or recurrence of disease during or following their latest line of therapy. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival.\n* Presence of at least one measurable lesion according to RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n* Adequate organ function based on laboratory values Further inclusion criteria apply.\n\nExclusion criteria:\n\n* Previous treatment with:\n\n  * Any small molecule HER2 inhibitor in the palliative setting in Cohorts D, E, F, H, L, L-ext, M, and N. In Cohort D allowed in up to 15 patients in each dose level (DL).\n  * T-DXd in Cohorts E and F. In Cohort E allowed in up to 15 patients in each DL.\n  * trastuzumab emtansine (T-DM1) in the palliative setting in Cohort D and H. In Cohort H allowed in up to 15 patients in each DL.\n  * Capecitabine in Cohort D and H. In Cohort D allowed in up to 15 patients in each DL\n* Presence of uncontrolled and\u002For symptomatic brain metastases, or leptomeningeal disease\n* Mean resting corrected QT interval (QT interval corrected for heart rate by Fridericia´s formula (QTcF)) \\>470 msec.\n* Any factors that increase the risk of QT interval corrected for heart rate (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, personal or family history of long QT syndrome or unexplained sudden death under 40 years-of-age.\n* Ejection fraction \\\u003C50% or the lower limit of normal of the institutional standard within 28 days prior to randomization\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening Further exclusion criteria apply.",{"count":345,"type":22},768,[52,25],"This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab and capecitabine, with zanidatamab, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.\n\nIn this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group.\n\nDuring the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT\u002FMRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects.",[28,349,350,351,352],"Metastatic Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Esophageal Adenocarcinoma","Colorectal Cancer","2026-08-05",{"date":329,"type":33},{"date":356,"type":33},"2024-06-28",{"date":358,"type":22},"2029-01-08",{"name":360,"class":78},"Boehringer Ingelheim",105,{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":370,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":41},"100632329","generative-ai-patient-education-module-for-breast-oncology-100632329","NCT07512271","Generative AI Patient Education Module for Breast Oncology","Accuracy and Effect of Prescribed Generative AI Patient Education Module Within Breast Oncology Care","Inclusion Criteria:\n\n1. Females or males ages 18 and over.\n2. Patients must have either:\n\n   1. Stage IV breast cancer facing a treatment change and are expected to have follow-up visits at least once every three months, or\n   2. Stage I-III breast cancer diagnosed within the past 6 months.\n3. Basic computer literacy and regular internet access at home.\n4. Able to understand study procedures and to comply with them for the entire length of the study.\n5. Ability of individual or legal guardian\u002Frepresentative to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Contraindication to any study-related procedure or assessment.\n2. Cognitive impairment that would interfere with tool usage or survey completion",{"count":260,"type":22},[240],"This study evaluates the safety, accuracy, and impact of an artificial intelligence (AI) tool designed to support patient education in breast cancer care for breast oncology patients under selected physicians care within the University of California, San Francisco breast cancer center and affiliate sites.",[121,28,373],"Carcinoma of the Breast",[375,376],"Artificial Intelligence (AI)","Digital Health","2026-08-04",{"date":329,"type":33},{"date":380,"type":33},"2026-07-14",{"date":382,"type":22},"2027-01-31",{"name":384,"class":40},"University of California, San Francisco",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":399,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":414},"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":394,"type":22},250,[118],"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.",[121,398,56,28,60],"HR-positive Breast Cancer",[64,400,127,401,402,403,404,405,406],"advanced, metastatic","progression","HR+","HER2-","capivasertib","eHealth","ePRO",{"date":353,"type":33},{"date":409,"type":33},"2025-11-27",{"date":411,"type":22},"2030-03",{"name":413,"class":40},"Women's Cancer Study Group GmbH",16,{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":23,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":41},"100406500","phase-2-evaluation-of-psma-in-her2--ar-metastatic-breast-cancer-100406500","NCT04573231","Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer","Evaluation of Prostate Specific Membrane Antigen (PSMA) in HER2-negative, Androgen Receptor (AR)-Positive Metastatic Breast Cancer With 18F-DCFPyL PSMA-based PET\u002FCT","Inclusion Criteria:\n\n* Patients diagnosed with metastatic HER2-negative breast cancer AR expression of ≥ 10%\n\nExclusion Criteria:\n\n* Other (non-breast) known active malignancy. Participants with previously treated cancers which are in remission or have no evidence of disease are eligible.\n* Unable to lie flat during or tolerate PET\u002FCT\n* Participants with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study\n* Women of childbearing potential must not be pregnant or breast feeding (pregnancy test negative within 7 days prior to PET\u002FCT",{"count":423,"type":22},13,[25],"The purpose of this research is to determine the expression of prostate specific membrane antigen (PSMA) in human epidermal growth factor receptor 2 (HER2)-negative, androgen receptor (AR)-positive metastatic breast cancer, and to determine its role in resistance to the anti-androgen, bicalutamide. The investigators hypothesize that PSMA expression will correlate with resistance to anti-androgen therapies, as has been documented in prostate cancer, and this can be used to select patients most likely to benefit from these therapies in future clinical trials. 15 people with HER2-negative, AR-positive metastatic breast cancer will be enrolled and be on study for about 3 days.",[121,60,28],{"date":308,"type":33},{"date":429,"type":33},"2021-05-24",{"date":431,"type":22},"2026-08",{"name":433,"class":40},"University of Wisconsin, Madison",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":442,"briefSummary":443,"conditions":444,"keywords":445,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":459},"100217003","aurora-aiming-to-understand-the-molecular-aberrations-in-metastatic-breast-cancer-100217003","NCT02102165","AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.","AURORA","Inclusion Criteria:\n\n1. Female or male ≥ 18 years with diagnosis of locally recurrent\u002Fadvanced BC not amenable to treatment with curative intent or MBC who have not received more than 1 line of systemic therapy (any type) in the metastatic setting.\n\n   Under protocol 4.0, eligible patients will be limited to locally recurrent\u002Fadvanced breast cancer not amenable to treatment with curative intent or MBC with:\n   * histopathology-confirmed TNBC as defined by ER \\\u003C1% and HER2 negative following ASCO-CAP guidelines\n   * ILC (either based on ILC morphology or negative E-cadherin expression confirmed by IHC). Mixed ILC\u002Finvasive ductal carcinoma are not eligible for the ILC cohort.\n   * late relapse BC (any subtype). Late relapse is defined as a patient with a radiologic or histologic confirmation of advanced or MBC relapse \\> 10 years from the primary BC diagnosis.\n2. Written informed consent prior to registration into the program.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n4. Availability of primary tumor tissue for research purposes.\n5. Patient must have a metastatic lesion accessible for biopsy and must agree with the biopsy procedure.\n\n   1. Up until protocol 3.0, up to 100 patients with bone-only metastasis have been included without a metastatic biopsy, if plasma samples have been collected at screening, and if the patient met all other eligibility criteria.\n   2. In protocol 4.0, metastatic tumor biopsies from bone lesions will be accepted provided that the chosen site of biopsy was not previously irradiated.\n   3. Brain tissue is accepted if it is obtained through surgical excision not planned for AURORA, but as part of the routine clinical practice.\n6. The biopsy of the metastatic lesion must be conducted either at the initial diagnosis of the BC relapse before the initiation of 1st line systemic therapy or at the 1st disease progression before initiation of a second line systemic treatment. There is no restriction in the type of therapeutic modality considered as 1st line systemic treatment, which can consist of any type of treatment administered after the diagnosis of the advanced BC relapse till the 1st disease progression thereafter.\n7. Biopsies obtained during routine clinical practice are accepted if both formalin-fixed paraffin-embedded (FFPE) and Frozen Tissue (FT) blocks were collected concurrently from the same metastatic lesion and if collected at the pre-specified timelines for AURORA.\n8. Availability of a whole blood, serum and plasma samples collected at the time of screening.\n9. Patient agrees to provide blood samples at regular intervals, from the screening as well as during the follow-up phase of the program.\n\nExclusion Criteria:\n\n1. The patient has received more than 1 line of systemic therapy (any type) in the metastatic setting.\n2. Patients who have received prior palliative radiotherapy to the only site that is accessible to biopsy.\n3. Presence of severe hematopoietic, renal, and\u002For hepatic dysfunction, including but not restricted to albumin \\\u003C 3 g\u002Fdl.\n4. Known increased risk of hemorrhage during biopsy procedure, as evaluated by the treating physician.\n5. Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.",{"count":178,"type":22},[240],"This program initially aims to recruit 1300 breast cancer patients from a large number of hospitals across Europe. Eligible patients are those who are 18 or older, either female or male, and who have not received more than 1 type of treatment from the time metastases were discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be collected for central analyses, together with blood, serum and plasma samples. Any samples not analyzed immediately will be stored in an independent bio-repository to enable future (not yet defined) research aimed at better understanding metastatic breast cancer.\n\nIn summary, the main objectives of AURORA are to better understand the genetic aberrations in metastatic breast cancer and to discover the mechanisms of response or resistance to therapy, in order to ultimately identify the \"right therapy for each individual patient\". At the same time, patients with genetic aberrations that are being targeted by new drugs in development will be offered the possibility to participate in clinical trials, when approved and available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all patients diagnosed with metastatic breast cancer.",[28],[446,64,127,447,448,449,450,451],"Aurora","molecular screening","targeted gene sequencing","molecular aberrations","exploratory","biomarker",{"date":329,"type":33},{"date":454,"type":33},"2014-04",{"date":456,"type":22},"2031-03",{"name":458,"class":40},"Jules Bordet Institute",52,{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":484},"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":469,"type":22},540,[118],"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.",[473,474,475,121,28,56],"PIK3CA Mutation","HER2- Negative Breast Cancer","Hormone Receptor Positive Tumor","2026-08-03",{"date":353,"type":33},{"date":479,"type":33},"2025-08-26",{"date":481,"type":22},"2031-12-31",{"name":483,"class":78},"Relay Therapeutics, Inc.",222,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":23,"phases":495,"briefSummary":496,"conditions":497,"keywords":500,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":512},"100619124","phase-2-evolutionary-clinical-trial-for-novel-biomarker-driven-therapies-100619124","NCT07340541","Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies","TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)","EVOLVE-BDT","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n* Age ≥ 18 years of age at the time of consent\n* ECOG Performance Status of 0-2 (see APPENDIX A: ECOG Performance Status Scale).\n* Patients must fulfill all eligibility criteria outlined in the LCCC2521 Parent Protocol and consented to LCCC2521 Parent Protocol\n\nExclusion Criteria:\n\n* Inaccessible metastatic lesion to research biopsy\n* Subject has already initiated 2nd line therapy\n* Concurrent disease or condition that in the opinion of the treating oncologist renders the patient inappropriate for study participation",{"count":494,"type":22},700,[25],"This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive\u002Fhormone receptor-negative (ER+\u002FHR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.",[121,28,498,265,499],"Triple Negative Breast Cancer","Hormone Receptor Negative Breast Carcinoma",[501,502],"biomarker directed therapies","biomarker stratified trial","2026-07-30",{"date":505,"type":33},"2026-07-31",{"date":507,"type":33},"2026-02-16",{"date":509,"type":22},"2031-06-02",{"name":511,"class":40},"UNC Lineberger Comprehensive Cancer Center",4,{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":527,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":539},"100544469","phase-2-a-study-of-alisertib-in-combination-with-endocrine-therapy-in-patients-with-hr-positive-her2-negative-recurrent-or-metastatic-breast-cancer-100544469","NCT06369285","A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer","A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer","ALISCA-Breast1","Inclusion Criteria:\n\n* Aged ≥18 years at signing of informed consent.\n* Pathology-confirmed diagnosis of breast cancer with evidence of recurrent or metastatic disease not amenable to curative therapy.\n* Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.\n* Participants must have received a CDK4\u002F6i in combination with endocrine therapy in the recurrent or metastatic setting.\n* HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) or European Society of Medical Oncology (ESMO) guidelines.\n\nExclusion Criteria:\n\n* Treatment with chemotherapy in the recurrent or metastatic setting, including antibody drug conjugates with a chemotherapeutic payload.\n* Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.\n\nNote: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.",{"count":522,"type":22},225,[25],"PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive\u002FHER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. Participants randomized prior to Amendment 4 are randomized 1:1:1 to Arm 1, Arm 2 or Arm 3. Participants randomized under Amendment 4 will be randomized 1:1 to Arm 1 or Arm 2.",[61,28,526],"Recurrent Breast Cancer",[528,529,526,28],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor 2 negative (HER2-)","2026-07-24",{"date":532,"type":33},"2026-07-27",{"date":534,"type":33},"2024-11-19",{"date":536,"type":22},"2029-06-30",{"name":538,"class":78},"Puma Biotechnology, Inc.",53,{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":23,"phases":550,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":559},"100507964","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-inavolisib-in-combination-with-phesgo-versus-placebo-in-combination-with-phesgo-in-participants-with-pik3ca-mutated-her2-positive-locally-advanced-or-metastatic-breast-cancer-100507964","NCT05894239","A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","INAVO122","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection\n* Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity\n* Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status\n* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \\>= 6 months\n* LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)\n* Adequate hematologic and organ function prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway\n* Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy\n* History or active inflammatory bowel disease\n* Disease progression within 6 months of receiving any HER2-targeted therapy\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Participants with active HBV infection\n* Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Symptomatic active lung disease, including pneumonitis or interstitial lung disease\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1\n* Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye",{"count":549,"type":22},230,[118],"This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).",[28],{"date":532,"type":33},{"date":555,"type":33},"2023-09-08",{"date":557,"type":22},"2032-12-28",{"name":228,"class":78},192,{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":23,"phases":569,"briefSummary":570,"conditions":571,"keywords":574,"overallStatus":243,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":591},"100648669","phase-2-smp-656-for-her2-positive-advanced-breast-cancer-100648669","NCT07726342","SMP-656 for HER2-Positive Advanced Breast Cancer","A Randomized, Open-Label, Dose-Optimization Phase II Clinical Trial to Evaluate the Efficacy and Safety of Single-Agent SMP-656 in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Progressed After Prior Treatment With HER2-Targeted Topoisomerase Inhibitor ADCs","Inclusion Criteria:\n\n1. Voluntarily participate in this clinical trial, understand and comply with study procedures, and provide written informed consent voluntarily;\n2. Female patients aged ≥ 18 years at the time of signing the informed consent form;\n3. Patients with histologically or cytologically confirmed unresectable HER2-positive locally advanced or metastatic breast cancer, regardless of hormone receptor (HR) status;\n4. HER2-positive status confirmed by testing at the study center or an accredited laboratory, where HER2 positivity is defined as IHC 3+, or IHC 2+ with positive fluorescence in situ hybridization (FISH+) results;\n5. Patients with HER2-positive locally advanced or metastatic breast cancer who have received prior treatment with one TOP inhibitor ADC targeting HER2 (e.g., DS-8201 and other ADCs with topoisomerase inhibitor payloads), and have experienced disease progression after no more than three lines of standard therapy for recurrent or metastatic disease; 1) Endocrine monotherapy is excluded from the abovementioned standard therapy lines; 2) Disease recurrence occurring within 12 months following neoadjuvant or adjuvant chemotherapy will be regarded as progression after first-line standard therapy;\n6. Have at least one measurable target lesion per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) ;\n7. ECOG performance status 0-1;\n8. Expected survival ≥ 3 months;\n9. Bone marrow, hepatic, renal and coagulation function shall be deemed adequate based on laboratory tests performed within 7 days prior to the first dose of the investigational product. Blood transfusion or growth factor supportive therapy is prohibited within 14 days before the first administration of the investigational product：\n\n   * Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelet count (PLT) ≥ 80 × 10⁹\u002FL; hemoglobin (Hb) ≥ 90 g\u002FL;\n   * Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); total serum bilirubin (TBIL) ≤ 1.5 × ULN, with the following exceptions;\n   * For participants with confirmed liver metastases: AST and\u002For ALT ≤ 5 × ULN;\n   * For participants diagnosed with Gilbert's syndrome: TBIL ≤ 3 × ULN;\n   * Serum albumin ≥ 30 g\u002FL;\n   * Renal function: Creatinine clearance (CrCL) ≥ 50 mL\u002Fmin (calculated via the Cockcroft-Gault formula), OR serum creatinine ≤ 1.5 × ULN;\n   * Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n10. Women of childbearing potential (WOCBP) must agree to use highly effective contraception or maintain abstinence from the time of informed consent signature through 6 months after the last administration of the investigational product；For WOCBP, serum pregnancy testing performed within 7 days prior to the first dose of the investigational product must yield a negative result.\n\nExclusion Criteria:\n\n1. Patients with inflammatory breast cancer;\n2. Have received eribulin in prior lines of therapy;\n3. Have received prior treatment with ADCs carrying tubulin inhibitor payloads for recurrent or metastatic disease;\n4. Prior anti-tumor therapy consisting of utidelone or vinca alkaloids as the last regimen;\n5. Patients with a known history of severe hypersensitivity to inetetamab, SMP-656, or any of their excipients;\n6. Patients with meningeal metastases;\n7. Patients with active central nervous system (CNS) metastases are excluded, with the following exception: symptomatic CNS metastases limited to supratentorial region and\u002For cerebellum (i.e., no midbrain, pons, medulla oblongata or spinal cord metastases) that have received local therapy, with neurological symptoms stabilized for at least 2 weeks prior to the first dose of investigational product, and no requirement for steroid therapy or receiving prednisone ≤10 mg\u002Fday (or equivalent corticosteroids) ;\n8. Patients diagnosed with any other malignancy (other than the study tumor type) within 5 years prior to the first dose of the investigational product, except curatively treated localized malignancies such as basal cell carcinoma of the skin;\n9. Previous, current or suspected interstitial lung disease (ILD), drug-induced interstitial lung disease; or clinically significant active pneumonia identified at screening; or radiation pneumonitis, or other severe pulmonary disorders impairing respiratory function, which in the Investigator's judgment may interfere with the detection or management of investigational product-related pulmonary toxicity;\n10. Patients with a clinically significant history of cardiovascular disease, including but not limited to： (1) Left ventricular ejection fraction (LVEF) \\\u003C 50%; congestive heart failure with New York Heart Association (NYHA) functional class \\> 2; (2) Have experienced myocardial infarction, unstable angina, severe pericardial disease or severe myocardial disease within the previous 6 months; (3) Presence of cardiac valve regurgitation or stenosis requiring therapeutic intervention; (4) Any supraventricular or ventricular arrhythmia requiring treatment or intervention; poorly controlled malignant arrhythmias despite medication; complete left bundle branch block, second-degree or third-degree atrioventricular block; (5) QTc interval \\> 470 ms at screening (for female participants), or known family history of long QT syndrome; (6) Uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive medication, or prior history of hypertensive crisis or hypertensive encephalopathy) ;\n11. History of arterial or venous thromboembolic events within 6 months prior to the first dose of the investigational product, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;\n12. Participants with uncontrollable pleural effusion, pericardial effusion or ascites as judged by the Investigator, which requires repeated drainage once every two weeks or more frequently. Participants with indwelling pleural catheters are permitted to enroll;\n13. Have received live attenuated vaccines within 4 weeks prior to the first dose of the investigational produc, or plan to receive live attenuated vaccines during the study;\n14. Patients with severe infection within 4 weeks prior to the first dose of the investigational product, including but not limited to bacteremia or severe pneumonia requiring hospitalization; or active infection with CTCAE Grade ≥2 requiring systemic antibiotic therapy within 2 weeks before the first dose (prophylactic antibiotics excluded) ;\n15. Patients meeting any of the following criteria will be excluded: patients with active hepatitis B or hepatitis C；For patients positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb), enrollment is permitted only if quantitative hepatitis B virus DNA (HBV-DNA) is below the upper limit of normal (ULN) of the study site laboratory；For patients positive for hepatitis C antibody (HCV-Ab), enrollment is permitted only if HCV RNA is below the ULN of the study site laboratory；Positive human immunodeficiency virus (HIV) antibody test; active syphilis infection; active tuberculosis infection;\n16. Patients with unresolved prior anti-tumor treatment-related toxicities (alopecia excluded) remaining at Grade \\>1 or not recovered to baseline, except adverse events (AEs) deemed not to pose a safety risk by the Investigator;\n17. Patients with Grade ≥2 peripheral neuropathy; or prior history of Grade ≥3 neurotoxicity \u002F peripheral neuropathy; or permanent discontinuation of previous anti-tumor treatment due to neurotoxicity or peripheral neuropathy;\n18. Patients with a history of allogeneic stem cell transplantation or solid organ transplantation, or those planning to receive allogeneic stem cell transplantation or solid organ transplantation during the study;\n19. Patients who have participated in any other clinical trial within 4 weeks or 5 half-lives prior to the first dose of the investigational product, whichever is shorter;\n20. Patients who received radiotherapy within 4 weeks prior to the first dose of the investigational product are excluded, except palliative radiotherapy administered for symptom control within 2 weeks before the first dose of investigational product;\n21. Patients who received systemic anti-tumor therapy within 4 weeks prior to the first dose of the investigational product are excluded, except for the following： 1) Enrollment is permitted only if at least 6 weeks have elapsed between the completion of prior nitrosourea or mitomycin chemotherapy and the first dose of the investigational product; 2) Enrollment is allowed only if a minimum of 1 week has passed between the discontinuation of prior small-molecule targeted therapy and the first dose of the investigational product; 3) Enrollment is permitted only if a minimum of 2 weeks have elapsed between discontinuation of prior traditional Chinese medicine with anti-tumor effects and the first dose of the investigational product;\n22. articipants who have undergone major surgery within 4 weeks prior to the first dose of the investigational product, or are expected to receive major surgery during the study period (diagnostic surgery excluded); those who received diagnostic or minimally invasive surgery within 1 week before the first dose are also excluded;\n23. Patients requiring long-term treatment with corticosteroids or immunosuppressive agents (e.g., active autoimmune diseases requiring systemic therapy). Replacement therapies such as thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency are permitted;\n24. Prior documented history of neurological or psychiatric disorders, including epilepsy or dementia;\n25. Female Patients who are pregnant, breastfeeding, or planning to become pregnant during the study;\n26. Patients with severe concomitant diseases that may compromise patient safety or interfere with study completion as judged by the Investigator (e.g., severe hypertension, diabetes mellitus, thyroid disorders), or any other conditions deemed inappropriate for study participation by the Investigator .",{"count":568,"type":22},60,[25],"The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor antibody-drug conjugate (ADC) treatment. It will also evaluate the safety of SMP-656 and identify the optimal dose for future trials. The main questions it aims to answer are:\n\nWhat is the objective tumor response rate (DOR, PFS, DCR, OS) of two different dose regimens of intravenous SMP-656? What are the side effects and safety risks of these two SMP-656 dose regimens? Which dose level achieves the best balance of anti-cancer activity and tolerability? This is a randomized, open-label, dose-optimization Phase II clinical trial. Participants will be randomly assigned 1:1 to receive one of two fixed doses of SMP-656 given intravenously once every 3 weeks.\n\nParticipants will:\n\nComplete screening tests within 28 days before the first SMP-656 infusion to confirm eligibility Receive study treatment every 3 weeks until cancer progression, intolerable side effects, withdrawal, or other stopping criteria Have regular tumor imaging scans, physical exams, vital sign checks, and blood tests to monitor tumor response and safety Attend a safety follow-up visit 30 days after the last dose of SMP-656 Complete longer-term survival follow-up after the 30-day safety check Provide optional blood and tumor tissue samples for additional research studies",[572,28,573],"HER2-positive Breast Cancer","Locally Advanced Breast Cancer (LABC)",[575,576,577,578,579,580,581,582,28],"SMP-656","Randomized Open-Label Trial","HER2","Antibody-Drug Conjugate","Trastuzumab Deruxtecan resistant","Phase II Trial","Dose Optimization","Topoisomerase Inhibitor","2026-07-22",{"date":530,"type":33},{"date":586,"type":22},"2026-07-16",{"date":588,"type":22},"2027-10-20",{"name":590,"class":78},"Chengdu SciMount Pharmatech Co., Ltd.",15,{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":602,"briefSummary":603,"conditions":604,"keywords":607,"overallStatus":243,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"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":601,"type":22},200,[118],"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.",[56,28,605,606],"HER2 Positive","HR Positive",[56,28,608,609,610],"T-DXd","HER2 positive","HR positive",{"date":612,"type":33},"2026-07-23",{"date":614,"type":22},"2026-09-04",{"date":616,"type":22},"2030-08-28",{"name":618,"class":78},"Daiichi Sankyo",{"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":89,"phases":4,"briefSummary":629,"conditions":630,"keywords":631,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":636,"leadSponsor":638,"locationsCount":168},"100548192","minimally-interventional-study-on-prevalence-of-emerging-esr1-mutations-in-liquid-biopsy-in-three-cohorts-of-patients-with-breast-cancer-in-comparison-with-patients-baseline-esr1-mutation-status-as-defined-by-tissue-profiling-100548192","NCT06417801","Minimally Interventional Study on Prevalence of Emerging ESR1 Mutations in Liquid Biopsy in Three Cohorts of Patients With Breast Cancer in Comparison With Patient's Baseline ESR1 Mutation Status as Defined by Tissue Profiling.","Minimally Interventional Study on Prevalence of Emerging ESR1 Mutations in Liquid Biopsy in Three Cohorts of Patients With Breast Cancer, With and Without Prior Therapies inMetastatic Setting, and During First-line Aromatase InhibitorPlus CDK4\u002F6 Inhibitor Therapy, in Comparison With Patient's Baseline ESR1 Mutation Status as Defined by Tissue Profiling.","Pangeia-2","Inclusion Criteria:\n\nCohort 1:\n\n* BC patients, male and female,\n* 18 years old and older,\n* Pre or post menopausal,\n* With HR+ (ER and\u002For PR positive) and Her-2 negative (confirmed centrally),\n* Locally advanced irresectable and\u002For metastatic disease\n* Confirmation of HR and Her-2 status may be performed in the primary tumor or in the metastatic lesion (patients with discordant results may be included),\n* Patients must be candidates to CDK4\u002F6i therapy in combination with endocrine therapy in the first line setting (with or without ovarian suppression)\n* Patients may have received one previous line of chemotherapy in the metastatic setting, but no endocrine therapy in the metastatic setting is allowed,\n* Patients may have received chemotherapy in the neo\u002Fadjuvant setting,\n* Patients may have received endocrine therapy (with or without ovarian suppression) in the neo\u002Fadjuvant setting,\n* Patients may have received a CDK4\u002F6i in the adjuvant setting, provided they are still candidates for CDK4\u002F6i therapy in the metastatic setting,\n* Patients must be able to undergo a liquid biopsy procedure before starting their first line treatment,\n* All patients must fill and sign an informed consent form.\n\nCohort 2:\n\n* BC patients,\n* Male and female,\n* 18 years old and older,\n* pre or post menopausal,\n* With HR+ (ER and\u002For PR positive) and Her-2 negative (confirmed centrally),\n* Locally advanced irresectable and\u002For metastatic disease who have progressed on a CDK4\u002F6i in combination with endocrine therapy (with or without ovarian suppression) in the first or second line setting,\n* All other non-conflicting inclusion criteria for cohort 1 apply.\n\nCohort 3:\n\n* BC Patients,\n* Male and female,\n* 18 years or older,\n* pre- or post-menopausal,\n* With HR+ (ER and\u002For PR positive), HER2-negative (centrally confirmed) locally advanced unresectable and\u002For metastatic disease,\n* Confirmation of HR and HER2 status may be performed on the primary tumour or the metastatic lesion (patients with discordant results may be included),\n* Patients must be on first-line hormonal therapy with an aromatase inhibitor plus a CDK4\u002F6 inhibitor (with or without ovarian suppression) for at least 6 months,\n* No clinical or radiological evidence of progressive disease,\n* Patients may have received a prior line of chemotherapy in the metastatic setting; however, prior endocrine therapy in the metastatic setting is not permitted,\n* Patients may have received chemotherapy in the neoadjuvant\u002Fadjuvant setting,\n* Patients may have received endocrine therapy (with or without ovarian suppression) in the neoadjuvant\u002Fadjuvant setting,\n* Patients may have received a CDK4\u002F6 inhibitor in the adjuvant setting, provided they are still eligible for CDK4\u002F6 inhibitor therapy in the metastatic setting,\n* Patients must be able to undergo a liquid biopsy procedure before starting their first-line treatment,\n* All patients must read and sign an Informed Consent Form.\n\nExclusion Criteria:\n\n* Patients WITHOUT HR+ (ER- and\u002For PR-positive)\u002FHER2-negative disease,\n* Patients without radiological and\u002For pathological confirmation of locally unresectable and\u002For metastatic breast cancer,\n* Patients who are NOT candidates for further systemic treatment following a diagnosis of metastatic disease or disease progression,\n* Patients who have already started a CDK4\u002F6 inhibitor in combination with endocrine therapy (with or without ovarian suppression) for first-line metastatic disease (for Cohort 1);\n* Patients who have already started a new line of treatment for metastatic disease following progression on a CDK4\u002F6 inhibitor in combination with endocrine therapy (with or without ovarian suppression) (for Cohort 2);\n* Patients with any suspicion of clinical or radiological disease progression at the time of the first liquid biopsy collection (for Cohort 3),\n* Patients who are NOT able to undergo a liquid biopsy procedure,\n* Patients who are NOT able to provide informed consent.","100 Years",{"count":5,"type":22},"Minimally interventional study on prevalence of emerging ESR1 mutations in liquid biopsy in three cohorts of patients with breast cancer (with and without prior therapies in metastatic setting, and during first-line aromatase inhibitor plus CDK4\u002F6 inhibitor therapy) in comparison with patient's baseline ESR1 mutation status as defined by tissue profiling.",[28],[632],"Breast Cancer; ER-positive; ESR-1 mutation","2026-07-21",{"date":583,"type":33},{"date":290,"type":33},{"date":637,"type":22},"2027-12-30",{"name":639,"class":78},"AstraZeneca",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":23,"phases":649,"briefSummary":650,"conditions":651,"keywords":653,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":670},"100579664","phase-1-a-clinical-study-to-find-the-optimal-dose-of-an-investigational-treatment-called-bnt323-when-used-in-combination-with-another-investigational-treatment-bnt327-and-to-test-if-that-combination-treatment-is-safe-and-beneficial-for-patients-with-advanced-breast-cancer-100579664","NCT06827236","A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer","A Phase I\u002FII, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer","Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified):\n\n* Have pathologically documented BC that:\n\n  * Is locally advanced, unresectable or metastatic.\n  * Has a confirmed HER2 status as determined by the local laboratory as standard of care testing prior to study screening (Part 1, Part 2 Cohorts 2 and 4) or the central laboratory (Part 2, Cohorts 1 and 3) from the most recently collected pre-randomization tumor sample.\n  * Has a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Clinical Oncology\u002FCollege of American Pathologists guidelines.\n* Have measurable disease defined by RECIST v1.1.\n* Has left ventricular ejection fraction ≥55% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization\u002Fenrollment.\n\nKey Exclusion Criteria:\n\n* Have history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.\n* Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization\u002Fenrollment.\n* Have a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Had prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads such as trastuzumab deruxtecan.\n* Have received any of the following therapies or drugs prior to the initiation of the study:\n\n  * Participants who have received prior treatment with BNT323.\n  * Participants who received prior treatment with a programmed death-ligand 1 (PD-L1) \u002F vascular endothelial growth factor (VEGF) bispecific antibody. Note: Prior treatment with programmed death 1 (PD-1)\u002FVEGF bispecific antibodies, PD-1\u002FPD-L1 inhibitors or anti-VEGF therapies are permitted.\n  * Have received other systemic immunostimulatory agents or immunosuppressive therapies (such as interferon-α, interleukin-2, or methotrexate) within 4 weeks prior to the initiation of study treatment or are within five half-lives of the treatment drug (whichever is longer). Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).\n  * Have received systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 3 weeks prior to the initiation of study treatment.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":648,"type":22},380,[52,25],"This is a Phase I\u002FII, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \\[IHC\\] 1+ or IHC 2+\u002Fin situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).",[182,652,28],"Unresectable Breast Carcinoma",[654,655,656,657,658,659,660,661],"Breast Cancer (BC)","Human epidermal growth factor receptor 2 (HER2)","IHC scores 0, 1+, 2+, and 3+","Antibody drug conjugate (ADC)","Programmed Death-1 (PD-1)","Programmed Death Ligand-1 (PD-L1)","Programmed Death-1 monoclonal antibodies","Anti vascular endothelial growth factor-A (anti-VEGF-A)","2026-07-20",{"date":633,"type":33},{"date":665,"type":33},"2025-04-23",{"date":667,"type":22},"2029-08",{"name":669,"class":78},"BioNTech SE",68]