[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592312":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Sacituzumab govitecan combined with Toripalimab",null,[12],"Drug: Sacituzumab Govitecan (SG)+Toripalimab",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Sacituzumab Govitecan (SG)+Toripalimab","Sacituzumab govitecan (Trodelvy): 10mg\u002Fkg, administered by intravenous infusion on day 1 and day 8.\n\nToripalimab: 240mg, administered by intravenous infusion on day 1.",[9],[20,21,22,23],"IMMU-132","Trodelvy™","GS-0132","Toripalimab",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Guohong Song, Doctor of Medicine (M.D.)","CONTACT","0086-88121122-2066","songguohong918@hotmail.com",[31],{"facility":32,"status":33,"city":34,"state":10,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Beijing Cancer Hospital","RECRUITING","Beijing","100142","China","CN",{"type":39,"coordinates":40},"Point",[41,42],116.39723,39.9075,{"lat":42,"lon":41},[45],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","songguohong","Chief Physician, Deputy Director of the Department, Medical Oncology of Breast Cancer","100592312","sacituzumab-govitecan--toripalimab-as-first---line-therapy-for-advanced-triple---negative-breast-cancer-and-biomarker-exploration-100592312",false,"NCT06991790","Sacituzumab Govitecan + Toripalimab as First - Line Therapy for Advanced Triple - Negative Breast Cancer and Biomarker Exploration","A Prospective, Single-arm, Multicenter Phase II Clinical Study of Sacituzumab Govitecan in Combination With Toripalimab as First-line Treatment for Advanced Triple-negative Breast Cancer and an Exploratory Study of Biomarkers for Predicting Efficacy","Inclusion Criteria:\n\n1. Female breast cancer patients aged 18 to 75 years old;\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0 to 1;\n3. Patients with histologically or cytologically confirmed advanced triple-negative breast cancer;\n4. Patients who have not received systemic treatment (including chemotherapy, targeted therapy and immunotherapy) for advanced triple-negative breast cancer;\n5. According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, having at least one measurable lesion;\n6. Deciding to receive anti-tumor treatment with the combination of sacituzumab govitecan and toripalimab.\n\nExclusion Criteria:\n\n1. Patients with symptomatic brain metastases (such as increased intracranial pressure, epilepsy, etc.) who require emergency radiotherapy or surgical intervention;\n2. Patients who have previously received HER2-targeted therapy or Trop-2-targeted therapy;\n3. Patients who have previously used or are currently using PD-(L)1 inhibitors and\u002For ADC drugs containing topoisomerase inhibitors, such as sacituzumab govitecan, Dato-DXd, etc., as well as topoisomerase inhibitors;\n4. Patients who are considered by the investigator to be unsuitable for participating in this study.","FEMALE","18 Years","75 Years",{"count":61,"type":62},51,"ESTIMATED","OBSERVATIONAL","The goal of this study is to explore the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment in patients with advanced triple - negative breast cancer.\n\nThe main questions it aims to answer are:\n\n1. To investigate the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer.\n2. To explore the biomarkers that can predict the efficacy of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer.\n\nParticipants will:\n\nHave their progression - free survival (PFS) observed and evaluated. Have all adverse events and immune - related adverse events monitored to assess safety.\n\nHave their objective response rate measured as a secondary outcome. Have their survival period tracked as a secondary outcome. Have biomarkers associated with efficacy observed and explored as a secondary outcome.",[66],"TNBC",[68,69,70,71,72,73],"sacituzumab govetican","toripalimab","ADC","triple-negative breast cancer","first-line therapy","immune-checkpoint inhibitor","2025-05-18",{"date":76,"type":77},"2025-05-28","ACTUAL",{"date":79,"type":77},"2025-05-01",{"date":81,"type":62},"2028-05-01",{"name":5,"class":6},1]