[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596068":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":27,"locations":36,"responsibleParty":54,"collaborators":27,"id":56,"slug":27,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":27,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":27,"enrollmentInfo":64,"targetDuration":27,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":81,"whyStopped":27,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"SG plus Toripalimab","EXPERIMENTAL","Participants will receive sacituzumab govitecan at 10 mg\u002Fkg via IV infusion on Days 1 and 8 of each 21-day cycle, and toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.",[13,14],"Drug: Sacituzumab Govitecan (SG)","Drug: Toripalimab",{"label":16,"type":17,"description":18,"interventionNames":19},"Nab-Paclitaxel plus Toripalimab","ACTIVE_COMPARATOR","Participants will receive toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle, and nab-paclitaxel at 125 mg\u002Fm² via IV infusion on Days 1 and 8 of each cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.",[14,20],"Drug: Nab-paclitaxel",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Sacituzumab Govitecan (SG)","Sacituzumab govitecan will be administered at 10 mg\u002Fkg via intravenous infusion on Days 1 and 8 of each 21-day cycle. The treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Toripalimab","Toripalimab will be administered at a fixed dose of 240 mg via intravenous infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.",[16,9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Nab-paclitaxel","Nab-paclitaxel will be administered at 125 mg\u002Fm² via intravenous infusion on Days 1 and 8 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.",[16],[37],{"facility":38,"status":27,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Sun Yat-sen Memorial Hospital of Sun Yat-sen University","Guangzhou","Guangdong","510120","China",{"type":44,"coordinates":45},"Point",[46,47],113.25,23.11667,{"lat":47,"lon":46},[50],{"name":38,"role":51,"phone":52,"phoneExt":27,"email":53},"CONTACT","+86 20 8133 2536","jiangzefei@csco.org.cn",{"type":55,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100596068",false,"NCT07040644","A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC","A Multi-center, Open-label, Randomized, Phase II Trial of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel as First-line Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer","Inclusion Criteria:\n\n* Female patients aged ≥18 years.\n* Histologically or cytologically confirmed triple-negative breast cancer (TNBC).\n* Unresectable locally advanced or metastatic disease.\n* PD-L1 positive (CPS ≥1 as assessed by central laboratory).\n* No prior systemic treatment for advanced or metastatic TNBC.\n* Measurable disease per RECIST v1.1.\n* ECOG performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal function.\n* Willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Prior treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.\n* Known active central nervous system metastases.\n* Active autoimmune disease or history of autoimmune disorders requiring systemic treatment.\n* Active infection requiring systemic therapy.\n* Pregnancy or lactation.\n* Other active malignancies requiring treatment within the past 5 years.\n* History of severe hypersensitivity reactions to study drugs.","FEMALE","18 Years",{"count":65,"type":66},150,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","This is a multicenter, open-label, randomized phase II trial evaluating the efficacy and safety of sacituzumab govitecan plus toripalimab versus toripalimab plus nab-paclitaxel in patients with previously untreated, unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) that is PD-L1 positive.\n\nEligible patients will be randomized in a 1:1 ratio to receive either sacituzumab govitecan plus toripalimab or toripalimab plus nab-paclitaxel. Tumor response will be assessed by investigators according to RECIST v1.1 at baseline, every 6 weeks during the first year, and every 12 weeks thereafter.\n\nThe primary objective is to evaluate progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to response (TTR), and safety profile according to NCI-CTCAE v5.0.",[72],"Triple Negative Breast Neoplasms",[74,75,29,76,77,78,79,80],"PD-L1 Positive","Sacituzumab Govitecan","Nab-Paclitaxel","Advanced Breast Cancer","Metastatic TNBC","Randomized Controlled Trial","Progression-Free Survival","NOT_YET_RECRUITING","2025-08-29",{"date":84,"type":85},"2025-09-08","ACTUAL",{"date":87,"type":66},"2025-09",{"date":89,"type":66},"2028-06",{"name":5,"class":6},1]