[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587325":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":46,"studyPopulation":11,"armGroups":47,"interventions":58,"overallOfficials":67,"centralContacts":71,"locations":77,"responsibleParty":226,"collaborators":11,"id":228,"slug":11,"hasResults":229,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":11,"eligibilityCriteria":233,"healthyVolunteers":229,"sex":234,"minAge":235,"maxAge":11,"enrollmentInfo":236,"targetDuration":11,"studyType":239,"phases":240,"briefSummary":243,"conditions":244,"keywords":11,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":11},[9,13,16,19,21,25],{"measure":10,"description":11,"timeFrame":12},"Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)",null,"First dose up to 28 days",{"measure":14,"description":11,"timeFrame":15},"Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs)","First dose up to 30 days post last dose (Up to 3 years)",{"measure":17,"description":11,"timeFrame":18},"Phases 1 and 2: Percentages of Participants Experiencing Laboratory Abnormalities","First dose up to 30 days post last dose (Up to 3 years).",{"measure":20,"description":11,"timeFrame":18},"Phases 1 and 2: Percentages of Participants Experiencing AEs Leading to Dose Reductions, Dose Interruptions, and Treatment Discontinuations",{"measure":22,"description":23,"timeFrame":24},"Phases 1 and 2: Objective Response Rate (ORR)","ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.","Up to 9 months",{"measure":26,"description":27,"timeFrame":24},"Phase 2: Progression-Free Survival (PFS)","PFS is defined as the time from the date of the first SG dose until the date of progressive disease (PD) as assessed by the investigator according to RECIST Version 1.1, or death from any cause, whichever occurs first.",[29,32,34,37],{"measure":30,"description":11,"timeFrame":31},"Phases 1 and 2: Serum Concentrations of SG","Up to End of Treatment (3 years)",{"measure":33,"description":11,"timeFrame":18},"Phase 1 and 2: Percentage of Participants who Develop Antidrug Antibodies (ADAs) Against SG",{"measure":35,"description":36,"timeFrame":18},"Phase 2: Duration of Response (DOR)","DOR is defined as the time from the first documentation of CR or PR to the first documentation of PD as assessed by the investigator according to RECIST Version 1.1, or death from any cause, whichever occurs first.",{"measure":38,"description":39,"timeFrame":24},"Phase 2: Disease Control Rate (DCR)","DCR is defined as the proportion of participants who achieve CR, PR, or stable disease as assessed by the investigator according to RECIST Version 1.1.",{"allocation":41,"interventionModel":42,"interventionModelDescription":11,"primaryPurpose":43,"observationalModel":11,"timePerspective":11,"maskingInfo":44},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":45,"maskingDescription":11,"whoMasked":11},"NONE","Phase 1 of this study will evaluate the preliminary safety, tolerability, pharmacokinetics (PK), and efficacy of SG. Phase 2 expansion of this study will further evaluate the safety, efficacy, and PK of SG.",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Phase 1","EXPERIMENTAL","Participants will receive SG until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.",[53],"Drug: Sacituzumab Govitecan-hziy (SG)",{"label":55,"type":50,"description":56,"interventionNames":57},"Phase 2: Expansion","Participants will receive SG until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.",[53],[59],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"DRUG","Sacituzumab Govitecan-hziy (SG)","Administered intravenously",[49,55],[65,66],"GS-0132","Trodelvy",[68],{"name":69,"affiliation":5,"role":70},"Gilead Study Director","STUDY_DIRECTOR",[72],{"name":73,"role":74,"phone":75,"phoneExt":11,"email":76},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[78,92,102,112,122,132,141,146,156,166,178,188,197,207,214,220],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":11},"Los Angeles Cancer Network (LACN) - Good Sam","RECRUITING","Los Angeles","California","90017","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-118.24368,34.05223,{"lat":90,"lon":89},{"facility":93,"status":80,"city":94,"state":95,"zip":96,"country":84,"countryCode":85,"cosmosGeoPoint":97,"geoPoint":101,"contacts":11},"Winship Cancer Institute - Emory University","Atlanta","Georgia","30322",{"type":87,"coordinates":98},[99,100],-84.38798,33.749,{"lat":100,"lon":99},{"facility":103,"status":80,"city":104,"state":105,"zip":106,"country":84,"countryCode":85,"cosmosGeoPoint":107,"geoPoint":111,"contacts":11},"The University of Kansas Hospital","Westwood","Kansas","66205",{"type":87,"coordinates":108},[109,110],-94.6169,39.04056,{"lat":110,"lon":109},{"facility":113,"status":80,"city":114,"state":115,"zip":116,"country":84,"countryCode":85,"cosmosGeoPoint":117,"geoPoint":121,"contacts":11},"Siteman Cancer Center","St Louis","Missouri","63110",{"type":87,"coordinates":118},[119,120],-90.19789,38.62727,{"lat":120,"lon":119},{"facility":123,"status":80,"city":124,"state":125,"zip":126,"country":84,"countryCode":85,"cosmosGeoPoint":127,"geoPoint":131,"contacts":11},"West Cancer Centre","Germantown","Tennessee","38138",{"type":87,"coordinates":128},[129,130],-89.81009,35.08676,{"lat":130,"lon":129},{"facility":133,"status":80,"city":134,"state":125,"zip":135,"country":84,"countryCode":85,"cosmosGeoPoint":136,"geoPoint":140,"contacts":11},"SCRI Oncology Partners","Nashville","37203",{"type":87,"coordinates":137},[138,139],-86.78444,36.16589,{"lat":139,"lon":138},{"facility":142,"status":80,"city":134,"state":125,"zip":135,"country":84,"countryCode":85,"cosmosGeoPoint":143,"geoPoint":145,"contacts":11},"Tennessee Oncology, PLLC",{"type":87,"coordinates":144},[138,139],{"lat":139,"lon":138},{"facility":147,"status":80,"city":148,"state":149,"zip":150,"country":84,"countryCode":85,"cosmosGeoPoint":151,"geoPoint":155,"contacts":11},"Texas Oncology - DFW","Dallas","Texas","75246",{"type":87,"coordinates":152},[153,154],-96.80667,32.78306,{"lat":154,"lon":153},{"facility":157,"status":80,"city":158,"state":159,"zip":160,"country":84,"countryCode":85,"cosmosGeoPoint":161,"geoPoint":165,"contacts":11},"Virginia Oncology Associates","Norfolk","Virginia","23502",{"type":87,"coordinates":162},[163,164],-76.28522,36.84681,{"lat":164,"lon":163},{"facility":167,"status":80,"city":168,"state":169,"zip":170,"country":171,"countryCode":172,"cosmosGeoPoint":173,"geoPoint":177,"contacts":11},"St. Vincent's Hospital - Kinghorn Cancer Center","Darlinghurst","New South Wales","2010","Australia","AU",{"type":87,"coordinates":174},[175,176],151.21925,-33.87939,{"lat":176,"lon":175},{"facility":179,"status":80,"city":180,"state":181,"zip":182,"country":171,"countryCode":172,"cosmosGeoPoint":183,"geoPoint":187,"contacts":11},"Sunshine Coast University Private Hospital","Birtinya","Queensland","4575",{"type":87,"coordinates":184},[185,186],153.11913,-26.74322,{"lat":186,"lon":185},{"facility":189,"status":80,"city":190,"state":181,"zip":191,"country":171,"countryCode":172,"cosmosGeoPoint":192,"geoPoint":196,"contacts":11},"John Flynn Private Hospital","Tugun","4224",{"type":87,"coordinates":193},[194,195],153.5,-28.15,{"lat":195,"lon":194},{"facility":198,"status":80,"city":199,"state":11,"zip":200,"country":201,"countryCode":11,"cosmosGeoPoint":202,"geoPoint":206,"contacts":11},"Seoul National University Hospital","Seoul","03080","South Korea",{"type":87,"coordinates":203},[204,205],126.9784,37.566,{"lat":205,"lon":204},{"facility":208,"status":209,"city":199,"state":11,"zip":210,"country":201,"countryCode":11,"cosmosGeoPoint":211,"geoPoint":213,"contacts":11},"Severance Hospital, Yonsei University Health System","NOT_YET_RECRUITING","03722",{"type":87,"coordinates":212},[204,205],{"lat":205,"lon":204},{"facility":215,"status":80,"city":199,"state":11,"zip":216,"country":201,"countryCode":11,"cosmosGeoPoint":217,"geoPoint":219,"contacts":11},"Asan Medical Center","05505",{"type":87,"coordinates":218},[204,205],{"lat":205,"lon":204},{"facility":221,"status":80,"city":199,"state":11,"zip":222,"country":201,"countryCode":11,"cosmosGeoPoint":223,"geoPoint":225,"contacts":11},"Samsung Medical Center","06351",{"type":87,"coordinates":224},[204,205],{"lat":205,"lon":204},{"type":227,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100587325",false,"NCT06926920","A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer","A Phase 1\u002F2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer","Key Inclusion Criteria:\n\n* Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent.\n* Histologically or cytologically locally confirmed TNBC.\n* Phase 1: Individuals with unresectable, locally advanced or metastatic TNBC who are refractory to or relapsed after at least one prior standard-of-care chemotherapy regimen or systemic therapy given for locally advanced or metastatic disease.\n* Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease.\n* Phase 2: Tumors must be PD-L1 negative, defined as tumor PD-L1 combined positive score (CPS) \\\u003C 10 using the PD-L1 immunohistochemistry (IHC) 22C3 assay. 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":237,"type":238},100,"ESTIMATED","INTERVENTIONAL",[241,242],"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).",[245],"Triple Negative Breast Cancer","2026-01-29",{"date":248,"type":249},"2026-01-30","ACTUAL",{"date":251,"type":249},"2025-04-30",{"date":253,"type":238},"2028-06",{"name":5,"class":6},16]