[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hrher2--advancedmetastatic-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hrher2--advancedmetastatic-breast-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100587510","phase-3-sirolimus-for-injection-albumin-bound-combined-with-fulvestrant-for-hrher2--advancedmetastatic-breast-cancer-patients-previously-treated-with-cdk46-inhibitors-100587510",false,"NCT06929325","Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+\u002FHER2- Advanced\u002FMetastatic Breast Cancer Patients Previously Treated With CDK4\u002F6 Inhibitors","A Randomized, Double-blind, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant Versus Placebo Combined With Fulvestrant in HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer Patients After Prior CDK4\u002F6 Inhibitor Treatment.","Inclusion Criteria:\n\n* 1\\. Aged 18 or above, regardless of gender; female patients must be postmenopausal, or premenopausal\u002Fperimenopausal.\n* 2\\. Pathologically confirmed HR+, HER2- breast cancer.\n* 3\\. Locally advanced or metastatic breast cancer, not suitable for curative surgery or radiotherapy, and no current clinical indication for chemotherapy.\n* 4\\. Previously received at least one, up to two lines of systemic therapy (including at least one line of endocrine therapy combined with CDK4\u002F6 inhibitor therapy).\n* 5\\. At least one measurable lesion according to RECIST 1.1 criteria.\n* 6\\. Willing to provide tumor and\u002For blood samples for biomarker testing; if unable to provide, subject to investigator and sponsor evaluation for eligibility.\n* 7\\. ECOG performance status score of 0-1.\n* 8\\. Investigator-assessed life expectancy ≥6 months.\n* 9\\. Adequate organ and bone marrow function.\n* 10\\. Premenopausal female patients using LHRH agonists to suppress ovarian function must agree to use two acceptable forms of highly effective contraception during the study and for 2 years after stopping study treatment; female patients of childbearing potential must have a negative pregnancy blood test before starting study treatment and must not be breastfeeding.\n* 11\\. Male patients must agree to use barrier contraception (i.e., condoms) during the study and for 2 years after stopping study treatment; for men with future fertility plans, sperm freezing is recommended before starting study treatment.\n* 12\\. Participants must provide informed consent before the trial and voluntarily sign the written ICF.\n\nExclusion Criteria:\n\n* 1\\. Previous pathological diagnosis of HER2-positive breast cancer.\n* 2\\. Patients judged by the investigator to be unsuitable for endocrine therapy.\n* 3\\. Patients who have previously received PI3K\u002FAKT\u002FmTOR inhibitors, fulvestrant, or other ER-targeted therapies (including oral SERDs, ER protein degraders PROTAC, etc.).\n* 4\\. Received chemotherapy, radiotherapy, biological therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before randomization.\n* 5\\. Received other unapproved investigational drugs within 4 weeks before randomization.\n* 6\\. Underwent major surgery within 4 weeks before randomization or has not fully recovered from any previous invasive procedures.\n* 7\\. Received systemic glucocorticoids (prednisone \\>10 mg\u002Fday or equivalent) or other immunosuppressive treatments within 2 weeks before randomization.\n* 8\\. Had an infection within 2 weeks before randomization requiring systemic (oral or IV) anti-infective treatment (uncomplicated urinary tract infections or upper respiratory tract infections excluded).\n* 9\\. Received inactivated or live attenuated vaccines or COVID-19 vaccines within 4 weeks before randomization.\n* 10\\. Used strong inhibitors or inducers of CYP3A4 hepatic metabolic enzymes within 2 weeks before randomization or still need to continue using such drugs.\n* 11\\. Diagnosed with other malignancies within 5 years before randomization.\n* 12\\. Suffering from severe cardiovascular or cerebrovascular diseases.\n* 13\\. Adverse reactions from previous anti-tumor treatments have not recovered to CTCAE 5.0 grade ≤1.\n* 14\\. Active leptomeningeal disease or poorly controlled central nervous system metastases.\n* 15\\. Presence of pleural\u002Fabdominal effusion or pericardial effusion with clinical symptoms or requiring symptomatic treatment.\n* 16\\. Known bleeding tendency (constitution) or coagulation disorders.\n* 17\\. History of severe lung diseases such as interstitial lung disease and\u002For pneumonia, pulmonary hypertension, or radiation pneumonitis requiring glucocorticoid treatment.\n* 18\\. Known hypersensitivity or intolerance to any component of the study drug or its excipients, or LHRH agonists (if applicable).\n* 19\\. History of autoimmune diseases (except tuberous sclerosis), immunodeficiency diseases, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or organ transplant history.\n* 20\\. Active HBV, HCV, syphilis, or tuberculosis infection.\n* 21\\. Other conditions judged by the investigator to be unsuitable for participation in this study.","ALL","18 Years",{"count":19,"type":20},312,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","A randomized, double-blind, multicenter phase III clinical study to evaluate the efficacy and safety of sirolimus for injection (albumin-bound) combined with fulvestrant in patients with HR+ and HER2- advanced breast cancer.",[26],"HR+\u002FHER2- Advanced\u002FMetastatic Breast Cancer","NOT_YET_RECRUITING","2025-04-14",{"date":30,"type":31},"2025-04-16","ACTUAL",{"date":33,"type":20},"2025-04",{"date":35,"type":20},"2027-12",{"name":37,"class":38},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY"]