[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587325":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":31,"locations":38,"responsibleParty":187,"collaborators":36,"id":189,"slug":190,"hasResults":191,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":36,"eligibilityCriteria":195,"healthyVolunteers":191,"sex":196,"minAge":197,"maxAge":36,"enrollmentInfo":198,"targetDuration":36,"studyType":201,"phases":202,"briefSummary":205,"conditions":206,"keywords":36,"overallStatus":41,"whyStopped":36,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1","EXPERIMENTAL","Participants will receive SG until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.",[13],"Drug: Sacituzumab Govitecan-hziy (SG)",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 2: Expansion","Participants will receive SG until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Sacituzumab Govitecan-hziy (SG)","Administered intravenously",[9,15],[25,26],"GS-0132","Trodelvy",[28],{"name":29,"affiliation":5,"role":30},"Gilead Study Director","STUDY_DIRECTOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)",null,"GileadClinicalTrials@gilead.com",[39,53,63,73,83,93,102,107,117,127,139,149,158,168,175,181],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":36},"Los Angeles Cancer Network (LACN) - Good Sam","RECRUITING","Los Angeles","California","90017","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-118.24368,34.05223,{"lat":51,"lon":50},{"facility":54,"status":41,"city":55,"state":56,"zip":57,"country":45,"countryCode":46,"cosmosGeoPoint":58,"geoPoint":62,"contacts":36},"Winship Cancer Institute - Emory University","Atlanta","Georgia","30322",{"type":48,"coordinates":59},[60,61],-84.38798,33.749,{"lat":61,"lon":60},{"facility":64,"status":41,"city":65,"state":66,"zip":67,"country":45,"countryCode":46,"cosmosGeoPoint":68,"geoPoint":72,"contacts":36},"The University of Kansas Hospital","Westwood","Kansas","66205",{"type":48,"coordinates":69},[70,71],-94.6169,39.04056,{"lat":71,"lon":70},{"facility":74,"status":41,"city":75,"state":76,"zip":77,"country":45,"countryCode":46,"cosmosGeoPoint":78,"geoPoint":82,"contacts":36},"Siteman Cancer Center","St Louis","Missouri","63110",{"type":48,"coordinates":79},[80,81],-90.19789,38.62727,{"lat":81,"lon":80},{"facility":84,"status":41,"city":85,"state":86,"zip":87,"country":45,"countryCode":46,"cosmosGeoPoint":88,"geoPoint":92,"contacts":36},"West Cancer Centre","Germantown","Tennessee","38138",{"type":48,"coordinates":89},[90,91],-89.81009,35.08676,{"lat":91,"lon":90},{"facility":94,"status":41,"city":95,"state":86,"zip":96,"country":45,"countryCode":46,"cosmosGeoPoint":97,"geoPoint":101,"contacts":36},"SCRI Oncology Partners","Nashville","37203",{"type":48,"coordinates":98},[99,100],-86.78444,36.16589,{"lat":100,"lon":99},{"facility":103,"status":41,"city":95,"state":86,"zip":96,"country":45,"countryCode":46,"cosmosGeoPoint":104,"geoPoint":106,"contacts":36},"Tennessee Oncology, PLLC",{"type":48,"coordinates":105},[99,100],{"lat":100,"lon":99},{"facility":108,"status":41,"city":109,"state":110,"zip":111,"country":45,"countryCode":46,"cosmosGeoPoint":112,"geoPoint":116,"contacts":36},"Texas Oncology - 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Alternatively, individuals with tumor CPS ≥ 10 will be eligible if they received an anti-PD-(L)1 agent (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant setting or if they cannot be treated with an anti-PD-(L)1 agent. due to a comorbidity.\n* Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype status.\n\nDuring Phase 1 safety run-in, individuals must be UGT1A1 wild-type.\n\nAfter Phase 1 safety run-in, individuals with any UGT1A1 genotype may be eligible.\n\n* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Adequate hematologic counts within 2 weeks prior to enrollment.\n* Adequate hepatic and renal function.\n\nKey Exclusion Criteria:\n\n* Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate (ADC) containing a topoisomerase inhibitor.\n* Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria will apply.","ALL","18 Years",{"count":199,"type":200},100,"ESTIMATED","INTERVENTIONAL",[203,204],"PHASE1","PHASE2","The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC).\n\nThe primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).",[207],"Triple Negative Breast Cancer","2026-01-29",{"date":210,"type":211},"2026-01-30","ACTUAL",{"date":213,"type":211},"2025-04-30",{"date":215,"type":200},"2028-06",{"name":5,"class":6},16]