[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587510":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":11,"studyPopulation":11,"armGroups":40,"interventions":52,"overallOfficials":11,"centralContacts":65,"locations":71,"responsibleParty":86,"collaborators":11,"id":88,"slug":11,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":11,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":11,"enrollmentInfo":96,"targetDuration":11,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":11,"overallStatus":105,"whyStopped":11,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-free Survival（PFS）",null,"Up to ~24 months",[14,17,19,21,23,25,27],{"measure":15,"description":11,"timeFrame":16},"Overall Survival（OS）","Up to ~36 months",{"measure":18,"description":11,"timeFrame":12},"Overall response rate（ORR）",{"measure":20,"description":11,"timeFrame":12},"Clinical benefit rate（CBR）",{"measure":22,"description":11,"timeFrame":12},"Disease control rate（DCR）",{"measure":24,"description":11,"timeFrame":12},"Duration of Response（DOR）",{"measure":26,"description":11,"timeFrame":12},"Safety and Tolerability：the incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)",{"measure":28,"description":11,"timeFrame":12},"PK metrics：plasma concentration of sirolimus",{"allocation":30,"interventionModel":31,"interventionModelDescription":11,"primaryPurpose":32,"observationalModel":11,"timePerspective":11,"maskingInfo":33},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":34,"maskingDescription":11,"whoMasked":35},"QUADRUPLE",[36,37,38,39],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[41,47],{"label":42,"type":43,"description":11,"interventionNames":44},"Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant","EXPERIMENTAL",[45,46],"Drug: Sirolimus for Injection (Albumin-bound)","Drug: Fulvestrant Injection",{"label":48,"type":49,"description":11,"interventionNames":50},"Placebo Combined with Fulvestrant","ACTIVE_COMPARATOR",[46,51],"Drug: Placebo for Sirolimus for Injection (Albumin-bound)",[53,58,62],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":11},"DRUG","Sirolimus for Injection (Albumin-bound)","IV infusion, every 2 weeks, 4 weeks per treatment cycle",[42],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"Fulvestrant Injection","IM injection, 500 mg, on day 1 and day 15 of Cycle 1, and then on day 1 of each cycle thereafter, 4 weeks per treatment cycle",[48,42],{"type":54,"name":63,"description":56,"armGroupLabels":64,"otherNames":11},"Placebo for Sirolimus for Injection (Albumin-bound)",[48],[66],{"name":67,"role":68,"phone":69,"phoneExt":11,"email":70},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",[72],{"facility":73,"status":11,"city":74,"state":75,"zip":11,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Clinical Trials Information Group","Shijiazhuang","Hebei","China","CN",{"type":79,"coordinates":80},"Point",[81,82],114.47861,38.04139,{"lat":82,"lon":81},[85],{"name":67,"role":68,"phone":69,"phoneExt":11,"email":70},{"type":87,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":97,"type":98},312,"ESTIMATED","INTERVENTIONAL",[101],"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.",[104],"HR+\u002FHER2- Advanced\u002FMetastatic Breast Cancer","NOT_YET_RECRUITING","2025-04-14",{"date":108,"type":109},"2025-04-16","ACTUAL",{"date":111,"type":98},"2025-04",{"date":113,"type":98},"2027-12",{"name":5,"class":6},1]