Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer (ASCENT-03)
Triple Negative Breast Cancer, PD-L1 Negative
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer
Eligibility Criteria
Key Inclusion Criteria:
Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
- Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo)adjuvant setting
- Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
- Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence
- Individuals presenting with de novo metastatic TNBC are eligible
- Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Demonstrates adequate organ function
- Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
- Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
Key Exclusion Criteria:
- Positive serum pregnancy test or women who are lactating
- Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
- Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
- May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
- Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
- Active second malignancy
- Active serious infection requiring antibiotics
- Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Alaska Oncology and HematologyRecruiting
- Arizona Oncology Associates, PC-Hope,1845 W Orange Grove RdRecruiting
- Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd.Recruiting
- Arizona Oncology Associates, PC-HopeRecruiting
- Arizona Oncology Associates, PC-Hope,1620 West St. Mary's RoadRecruiting
- Genesis Cancer and Blood Institute,1455 Higdon Ferry Road Suite B.Recruiting
- Genesis Cancer and Blood InstituteRecruiting
- Saint Bernards Medical CenterRecruiting
- Saint Bernards Medical Center,4000 Linwood DriveRecruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200Recruiting
- University of California San Diego Moores CancerRecruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200Recruiting
- Cancer and Blood Specialty ClinicRecruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240Recruiting
- Sansum ClinicRecruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600Recruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304Recruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer CenterRecruiting
- Sansum Clinic,2040 Viborg RoadRecruiting
- Torrance Memorial Physician Network - Cancer CareRecruiting
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100Recruiting
- Rocky Mountain Cancer Centers,1700 South Potomac StreetRecruiting
- Rocky Mountain Cancer CentersRecruiting
- Rocky Mountain Cancer Centers,2312 N. Nevada AvenueRecruiting
- Rocky Mountain Cancer Centers,6031 E. Woodman Rd.Recruiting
- Rocky Mountain Cancer Centers,4700 E. Hale ParkwayRecruiting
- Rocky Mountain Cancer Centers,11750 West 2nd PlaceRecruiting
- Rocky Mountain Cancer Centers,22 West Dry Creek CircleRecruiting
- Rocky Mountain Cancer Centers,10107 Ridge Gate ParkwayRecruiting
- Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210Recruiting
- Rocky Mountain Cancer Centers,3676 Parker BlvdRecruiting
- Rocky Mountain Cancer Centers,525 W. 15th StreetRecruiting
- Rocky Mountain Cancer Centers,8820 Huron StreetRecruiting
- Eastern Connecticut Hematology and Oncology AssociatesRecruiting
- AdventHealth Medical GroupRecruiting
- Florida Cancer Specialists - North Region Research Office,106 Boston AveRecruiting
- Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 ARecruiting
- Florida Cancer Specialists,3630 Manatee Avenue WestRecruiting
- Florida Cancer Specialists,5985 Silver Falls RunRecruiting
- Florida Cancer Specialists - North Region Research Office,403 S. Kings Ave.Recruiting
- Florida Cancer Specialists,1030 Commerce Creek BlvdRecruiting
- Florida Cancer Specialists - North Region Research Office,3280 McMullen Booth RoadRecruiting
- Florida Cancer Specialists - West Palm Beach,224 Memorial Medical Parkway, Suite 300Recruiting
- Holy Cross Hospital, IncRecruiting
- Florida Cancer SpecialistsRecruiting
- Florida Cancer Specialists,8981 Colonial Center DriveRecruiting
- Florida Cancer Specialists,8260 Gladiolus DrRecruiting
- Florida Cancer Specialists - North Region Research Office,6420 W. Newberry RoadRecruiting
- Florida Cancer Specialists - North Region Research Office,100 Highland AvenueRecruiting
- Florida Cancer Specialists - North Region Research Office,521 North Lecanto HighwayRecruiting
- Florida Cancer Specialists,1100 Goodlette RoadRecruiting
- Florida Cancer Specialists,681 4th Avenue NorthRecruiting
- Florida Cancer Specialists - North Region Research Office,4945 SW 49th PlaceRecruiting
- Florida Cancer Specialists - North Region Research Office,765 Image WayRecruiting
- AdventHealth Medical Group,2501 North Orange AveRecruiting
- Florida Cancer Specialists - North Region Research Office,70 W. Gore StreetRecruiting
- Sacred Heart Heatlh System, Inc., d/b/a Ascension Sacred HeartRecruiting
- Florida Cancer Specialists,22395 Edgewater DriveRecruiting
- Florida Cancer Specialists - North Region Research Office,1201 Fifth Avenue NorthRecruiting
- Florida Cancer Specialists - North Region Research OfficeRecruiting
- Sacred Heart Heatlh System, Inc., d/b/a Ascension Sacred Heart,27 Mack Bayou LoopRecruiting
- Florida Cancer Specialists,600 North Cattlemen RoadRecruiting
- Florida Cancer Specialists,1970 Golf StreetRecruiting
- Florida Cancer Specialists - North Region Research Office,7154 Medical Center DriveRecruiting
- Florida Cancer Specialists - West Palm Beach,301 SE Ocean Blvd, Suite 102Recruiting
- Florida Cancer Specialists - North Region Research Office,3402 West Dr. Martin Luther King Jr. BoulevardRecruiting
- Florida Cancer Specialists - North Region Research Office,4100 Waterman WayRecruiting
- Florida Cancer Specialists - North Region Research Office,1400 US Highway 441 NRecruiting
- Florida Cancer Specialists - North Region Research Office,9320 State Road 54Recruiting
- Florida Cancer Specialists,901 South Tamiami TrailRecruiting
- Florida Cancer Specialists,836 Sunset Lake BlvdRecruiting
- Florida Cancer Specialists - West Palm Beach,3730 7th Terrace, Suite 101Recruiting
- Florida Cancer Specialists - West Palm Beach,1037 S. State Road 7, Bldg B, Suite 303Recruiting
- Florida Cancer Specialists - West Palm BeachRecruiting
- Florida Cancer Specialists - North Region Research Office,460 N Orlando AveRecruiting
- Northside Hospital,125 King AvenueRecruiting
- Piedmont Cancer Institute - Atlanta,1267 Hwy 54WRecruiting
- Piedmont Cancer Institute - AtlantaRecruiting
- Northside Hospital,5670 Peachtree Dunwoody Rd.Recruiting
- Northside HospitalRecruiting
- Northside Hospital,308 Deep South Farm Rd, Suite 200Recruiting
- Northside Hospital,228 Riverstone Dr.Recruiting
- Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,157 Clinic AvenueRecruiting
- Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,100 Market Place BlvdRecruiting
- Northside Hospital,1505 Northside Blvd, Suite 4600Recruiting
- Northside Hospital,3855 Pleasant Hill Rd., Suite 480Recruiting
- Northside Hospital,308 Coliseum Dr.Recruiting
- Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PCRecruiting
- Piedmont Cancer Institute - Atlanta,775 Poplar RoadRecruiting
- Piedmont Cancer Institute - Atlanta,1240 Eagles Landing PkwyRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityRecruiting
- University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)Recruiting
- Orchard Healthcare Research Inc,2845 North Sheridan Road, 1st FloorRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1 Kish Hospital DriveRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,10 Health Services DriveRecruiting
- Orchard Healthcare Research Inc,800 Austin Street, Suite 360, East TowerRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,300 Randall RoadRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,304 Randall RoadRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1000 N. Westmoreland RoadRecruiting
- Orchard Healthcare Research IncRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4405 Weaver ParkwayRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4455 Weaver ParkwayRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,25 N Winfield RoadRecruiting
- Fort Wayne Medical Oncology and Hematology - FortRecruiting
- The University of Kansas Cancer Center,2000 Olathe BlvdRecruiting
- The University of Kansas Cancer Center,12200 W. 110th StreetRecruiting
- The University of Kansas Cancer Center,10710 Nall AvenueRecruiting
- The University of Kansas Cancer Center,10730 Nall AvenueRecruiting
- The University of Kansas Cancer CenterRecruiting
- Norton Cancer Institute - Saint Matthews,234 E. Gray StrretRecruiting
- Norton Cancer Institute - Saint Matthews,676 S. Floyd StreetRecruiting
- Norton Cancer Institute - Saint MatthewsRecruiting
- Norton Cancer Institute - Saint Matthews,4955 Norton Healthcare BlvdRecruiting
- Hematology Oncology Clinic - Baton RougeRecruiting
- Hematology Oncology Clinic - Baton Rouge,1673 E Mount Please DriveRecruiting
- Mercy Medical CenterRecruiting
- Cancer Institute Ascension Saint AgnesRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Massachusetts General HospitalRecruiting
- Massachusetts General Hospital,102 Endicott StreetRecruiting
- Massachusetts General Hospital,2014 Washington StRecruiting
- Ascension St. John HospitalRecruiting
- Ascension Providence HospitalRecruiting
- The West Clinic, PLLC dba West Cancer Center,7668 Airways BlvdRecruiting
- The University of Kansas Cancer Center,2750 Clay Edwards DriveRecruiting
- The University of Kansas Cancer Center,8700 North Green Hills RoadRecruiting
- The University of Kansas Cancer Center,4881 N.E. Goodview CircleRecruiting
- Nebraska Cancer Specialists,2730 W. Faidley AveRecruiting
- Nebraska Cancer Specialists,8303 Dodge StreetRecruiting
- Nebraska Cancer SpecialistsRecruiting
- Nebraska Cancer Specialists,611 Fenwick DrRecruiting
- Summit Medical Group Eastside Clinic,1 Diamond Hill RoadRecruiting
- Summit Medical Group Eastside ClinicRecruiting
- Rutgers Cancer Institute of New Jersey,414 Grand StreetRecruiting
- Rutgers Cancer Institute of New Jersey,600 River AvenueRecruiting
- Rutgers Cancer Institute of New Jersey,94 Old Short Hills RoadRecruiting
- Rutgers Cancer Institute of New Jersey,300 Second AveRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Rutgers Cancer Institute of New Jersey,150 Bergen St.Recruiting
- Rutgers Cancer Institute of New Jersey,201 Lyons AvenueRecruiting
- Capital Health Medical Center - HopewellRecruiting
- Rutgers Cancer Institute of New Jersey,110 Rehill AveRecruiting
- Rutgers Cancer Institute of New Jersey,99 Highway 37 WestRecruiting
- Rutgers Cancer Institute of New Jersey,100 State Route 36Recruiting
- New York Cancer & Blood Specialists - Port Jeffers,72 East Main St.Recruiting
- New York Cancer & Blood Specialists - Port Jeffers,12 East 86th St, Suite 4Recruiting
- Montefiore Medical Center - Montefiore Medical ParkRecruiting
- New York Cancer & Blood Specialists - Port Jeffers,2330 Eastchester Road, Suite 360Recruiting
- Hematology Oncology Associates of Central New YorkRecruiting
- Queens Hospital CenterRecruiting
- New York Cancer & Blood Specialists - Port Jeffers,1 Delaware Dr.Recruiting
- NYP/Columbia Univeresity Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
- New York Cancer & Blood Specialists - Port Jeffers,365 East Main St.Recruiting
- New York Cancer & Blood Specialists - Port Jeffers,49 Rte. 347, Newconset HwyRecruiting
- New York Cancer & Blood Specialists - Port JeffersRecruiting
- New York Cancer & Blood Specialists - Port Jeffers,1500 Rte, 112, Building 4Recruiting
- New York Cancer & Blood Specialists - Port Jeffers,750 Old County Rd. Suite 4Recruiting
- Novant Health Cancer Institute - Forsyth,125 Queens Road, Suite 650Recruiting
- Novant Health Cancer Institute - Forsyth,2131 S. 17th StreetRecruiting
- Novant Health Cancer Institute - ForsythRecruiting
- Zangmeister Cancer CenterRecruiting
- Northwest Cancer Specialists, P.C,5050 NE Hoyt St.Recruiting
- Northwest Cancer Specialists, P.C,265 N. BroadwayRecruiting
- Northwest Cancer Specialists, P.CRecruiting
- Magee-Womens Hospital of UPMC,2500 West 12th StreetRecruiting
- Magee-Womens Hospital of UPMC,201 State Street, 6 MainRecruiting
- Magee-Womens Hospital of UPMC,4300 Londonberry RoadRecruiting
- Magee-Womens Hospital of UPMC,2035 Technology ParkwayRecruiting
- University of Pennsylvania Abramson Cancer CenterRecruiting
- Magee-Womens Hospital of UPMCRecruiting
- Magee-Womens Hospital of UPMC,5115 Centre AvenueRecruiting
- Magee-Womens Hospital of UPMC,1703 Innovation DriveRecruiting
- Tennessee Oncology, PLLC,103 Natchez Park DriveRecruiting
- Tennessee Oncology, PLLC,4488 Carothers ParkwayRecruiting
- Tennessee Oncology, PLLC,225 Big Station Camp BlvdRecruiting
- The West Clinic, PLLC dba West Cancer CenterRecruiting
- Tennessee Oncology, PLLC,353 New Shackle Island RoadRecruiting
- Tennessee Oncology, PLLC,5653 First Blvd.Recruiting
- Tennessee Oncology, PLLC,103 Physicians WayRecruiting
- Tennessee Oncology, PLLC,1840 Medical Center ParkwayRecruiting
- Tennessee Oncology, PLLC,2004 Hayes StreetRecruiting
- Tennessee Oncology, PLLCRecruiting
- Tennessee Oncology, PLLC,4220 Harding RdRecruiting
- Tennessee Oncology, PLLC,3443 Dickerson RoadRecruiting
- Tennessee Oncology, PLLC,397 Wallace RoadRecruiting
- Tennessee Oncology, PLLC,120 Frank Martin RoadRecruiting
- Tennessee Oncology, PLLC,300 Stonecrest BlvdRecruiting
- The Center for Cancer & Blood Disorders - Magnolia,515 W. Mayfield Rd.Recruiting
- Texas Oncology PA,901 West 38th StreetRecruiting
- Texas Oncology PARecruiting
- Texas Oncology PA,4101 James Casey, Suite 100Recruiting
- The Center for Cancer & Blood Disorders - Magnolia,11805 South FreewayRecruiting
- Texas Oncology-Baylor Charles A. Sammons Cancer CenterRecruiting
- Texas Oncology-DenisonRecruiting
- The Center for Cancer & Blood Disorders - MagnoliaRecruiting
- Oncology Consultants,1631 North Loop WestRecruiting
- Oncology Consultants,925 GessnerRecruiting
- Oncology ConsultantsRecruiting
- Mays Cancer CenterRecruiting
- The Center for Cancer & Blood Disorders - Magnolia,920 Santa Fe DriveRecruiting
- Virginia Oncology Associates,744 N. Battlefield BlvdRecruiting
- Virginia Cancer Specialists, PC,7501 Right Flank RoadRecruiting
- Virginia Oncology Associates,1051 Loftis Blvd Suite 100Recruiting
- Virginia Oncology AssociatesRecruiting
- Virginia Cancer Specialists, PC,210 Medical Park BoulevardRecruiting
- Virginia Cancer Specialists, PC,1401 Johnston-Willis DriveRecruiting
- Virginia Cancer Specialists, PCRecruiting
- Virginia Oncology Associates,1950 Glenn Mitchell DriveRecruiting
- Swedish Cancer Institute-First Hill,21632 Highway 99Recruiting
- Swedish Cancer Institute-First Hill,751 NE Blakely DriveRecruiting
- Swedish Cancer Institute-First HillRecruiting
- Swedish Cancer Institute-First Hill,747 BroadwayRecruiting
- Northwest Cancer Specialists, P.C,210 SE 136th AvenueRecruiting
- Hospital Británico de Buenos AiresRecruiting
- Instituto de Oncologia Angel H.RoffoRecruiting
- Fundacion CORI para la Investigacion y Prevencion del CancerRecruiting
- Instituto de Oncología de RosarioRecruiting
- Centro para la Atencion Integral del Paciente Oncologico Centro Médico C.A.I.P.ORecruiting
- Clinica ViedmaRecruiting
- Border Medical OncologyRecruiting
- Saint George Hospital - AustraliaRecruiting
- Mater Hospital - North SydneyRecruiting
- GenesisCare - North ShoreRecruiting
- Mater Misericordiae Limited and Mater Research LimitedRecruiting
- Princess Alexandra HospitalRecruiting
- Cancer Research SA (CRSA)Recruiting
- Icon Cancer Centre HobartRecruiting
- Monash Medical CentreRecruiting
- Austin HospitalRecruiting
- Breast Cancer Research Center - Western AustraliaRecruiting
- Universitätsklinikum GrazRecruiting
- Medizinische Universität InnsbruckRecruiting
- Ordensklinikum Linz GmbH Barmherzige SchwesternRecruiting
- Landeskrankenhaus SalzburgRecruiting
- Universitätsklinikum Sankt PöltenRecruiting
- Landesklinikum Wiener NeustadtRecruiting
- Medizinische Universität WienRecruiting
- Algemeen Ziekenhuis KlinaRecruiting
- Cliniques Universitaires Saint-LucRecruiting
- Universitair Ziekenhuis BrusselRecruiting
- Grand Hopital de Charleroi - Notre DameRecruiting
- Universitair Ziekenhuis GentRecruiting
- UZ LeuvenRecruiting
- Centre Hospitalier Universitaire Université CatholRecruiting
- Hospital Araújo Jorge - Associação de Combate ao Câncer em Goiás - ACCGRecruiting
- ONCOSITE - Centro de Pesquisa Clinica em OncologiaRecruiting
- Catarina Pesquisa ClínicaRecruiting
- Hospital Amaral CarvalhoRecruiting
- Hospital Moinhos de VentoRecruiting
- Hospital de Clinicas de Porto Alegre - HCPARecruiting
- Hospital Sao Lucas da PUCRSRecruiting
- Instituto Nacional de Câncer - INCA - HCIIIRecruiting
- Núcleo de Oncologia da BahiaRecruiting
- CEPHO - Centro de Estudos e PesquisaS de Hematologia e OncologiaRecruiting
- Real e Portuguesa de Beneficéncia - Hospital Beneficéncia Portuguesa (BP) - Unidade PaulistaRecruiting
- Clinica de Pesquisas e Centro de Estudos em OncoloRecruiting
- Fundação Pio XII - Hospital de Amor de BarretosRecruiting
- Nucleo de Pesquisa Clinica da Rede Sao CamiloRecruiting
- Cross Cancer InstituteRecruiting
- QEII Health Sciences CentreRecruiting
- Grand River Regional Cancer Centre at Grand River HospitalRecruiting
- London Health Sciences CentreRecruiting
- McGill University Health CentreRecruiting
- Jewish General HospitalRecruiting
- Ottawa Hospital - General CampusRecruiting
- CISSS du Bas-Saint-Laurent - Hôpital régional de RimouskiRecruiting
- Sunnybrook Research InstituteRecruiting
- Mount Sinai HospitalRecruiting
- British Columbia Cancer - VancouverRecruiting
- Oncovida - SantiagoRecruiting
- Clínica IRAMRecruiting
- Centro de Oncología de PrecisiónRecruiting
- Clínica AlemanaRecruiting
- James Lind Centro de Investigacion del CancerRecruiting
- Masarykuv onkologicky ustav, klinika komplexni onkologickie peceRecruiting
- Fakultní Thomayerova nemocniceRecruiting
- Fakultni nemocnice Hradec Kravlove, Klinika onkologie a radioterapieRecruiting
- Fakultni nemocnice Olomouc, Onkologicka klinikaRecruiting
- Vseobecna Fakultni Nemocnice v PrazeRecruiting
- Fakultni nemocnice Karlovske Vinohrady, Radioterapeuticka a onkologicka klinikaRecruiting
- Sainte Catherine Institut du Cancer Avignon ProvenceRecruiting
- Centre Hospitalier Régional et Universitaire de BeRecruiting
- Hôpital Morvan, Institut de cancérologieRecruiting
- Centre francois BaclesseRecruiting
- Centre Jean PerrinRecruiting
- Centre de Cancérologie du Grand MontpellierRecruiting
- Hôpital Privé du ConfluentRecruiting
- Hospices Civils de Lyon Hôpital Lyon SudRecruiting
- Centre Armoricain de Radiothérapie, dImagerie MédRecruiting
- Centre Eugène MarquisRecruiting
- Institut Claudius Regaud - IUCT-ORecruiting
- Institut Gustave RoussyRecruiting
- Helios Klinikum Berlin-BuchRecruiting
- Gynakologisches Zentrum Bonn, Schwerpunkt Gyn. Onkologie,Recruiting
- Universitätsklinikum Erlangen, Frauen klinikRecruiting
- Kliniken Essen-Mitte - Evangelische Huyssens-Stift Breast UnitRecruiting
- Praxis für interdisziplinäre Onkologie & HämatologRecruiting
- Universitatsklinikum Hamburg-EppendorfRecruiting
- Facharztzentrum EppendorfRecruiting
- Nationales Centrum für Tumorerkrankungen - HeidelbRecruiting
- Klinik Frauenheilkunde, Uniklinik ClO, StudienzentraleRecruiting
- Universitätsklinikum Schleswig-Holstein Institut fur Klinische ChermieRecruiting
- Universitatsklinikum Mannheim GmBH, FrauenklinikRecruiting
- Universitätsklinikum Münster, Bereich Senologie an der klinik fur Frauenheilkunde und GerburtschilfeRecruiting
- Evangelisches Krankenhaus Bethesda MönchengladbachRecruiting
- Rotkreuzklinikum MunchenRecruiting
- Klinik und Poliklinik für FrauenheilkundeRecruiting
- Universitätsklinikum TübingenRecruiting
- St. Josefs-Hospital Wiesbaden GmbH , Gynäkologie und GeburtshilfeRecruiting
- Hong Kong Integrated Oncology CentreRecruiting
- Queen Mary HospitalRecruiting
- Prince of Wales Hospital - Hong KongRecruiting
- Queen Mary HospitalRecruiting
- Uzsoki Utcai Kornaz, Onkoradiologiai OsztalyRecruiting
- Debreceni Egyetem Klinikai KözpontRecruiting
- Petz Aladar Egyetemi Oktaté Kérhaz - OsztalyRecruiting
- Soroka Medical CenterRecruiting
- Rambam Health Care CampusRecruiting
- Shaare Zedek Medical CenterRecruiting
- Hadassah - Hebrew University Medical CenterRecruiting
- Meir Medical CenterRecruiting
- Rabin Medical CenterRecruiting
- Kaplan Medical CenterRecruiting
- Sheba Medical Center Hospital - Tel HashomerRecruiting
- Tel Aviv Sourasky Medical CenterRecruiting
- IRCCS Istituto Tumori "G.Paolo II"Recruiting
- SSD Oncologia Medica Addarii-Zamagni, IRCSS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'OrsolaRecruiting
- UO Oncologia, ASST degli Spedali Civili di BresciaRecruiting
- IRCSS Ospedale Policlinico San MartinoRecruiting
- S.C. Oncologia medica, ASST di LeccoRecruiting
- Presidio Ospedaliero di LuccaRecruiting
- Fondazione IRCCS - Istituto Nazionale dei TumoriRecruiting
- Azienda Socio Sanitaria TerritorialeRecruiting
- Oncologia Medica Senologica Sperimentale - Istituto Nazionale Tumori IRCCS Fondazione G. PascaleRecruiting
- Azienda Ospedaliero-Universitaria Maggiore della CRecruiting
- Istituto Oncologico Veneto - IRCCSRecruiting
- S.O.C Patologia Clinica (Laboratorio Analisi), Nuovo Ospedale di Prato - Santo StefanoRecruiting
- AOU Policlinico Umberto IRecruiting
- Fondazione Policlinico Universitario Agostino GemeRecruiting
- Azienda Ospedaliera Universitaria Senese - LospedRecruiting
- Aichi Cancer Center HospitalRecruiting
- Tohoku University HospitalRecruiting
- Juntendo University HospitalRecruiting
- Chiba Cancer CenterRecruiting
- Osaka Prefectural Hospital Organization - Osaka InRecruiting
- Shikoku Cancer CenterRecruiting
- Fukushima Medical University HospitalRecruiting
- Saitama Cancer CenterRecruiting
- Hakuaikai Sagara HospitalRecruiting
- National Cancer Center Hospital EastRecruiting
- Kumamoto University HospitalRecruiting
- Kure Medical Center And Chugoku Cancer CenterRecruiting
- Mie University HospitalRecruiting
- National Hospital Organization Kyushu Cancer CenterRecruiting
- Nagoya University HospitalRecruiting
- Nagoya City University HospitalRecruiting
- Hiroshima City Hiroshima Citizens HospitalRecruiting
- Niigata Cancer Center HospitalRecruiting
- Okayama University HospitalRecruiting
- Gunma Prefectural Cancer CenterRecruiting
- Kyoto University HospitalRecruiting
- Hokkaido Cancer CenterRecruiting
- Shizuoka General HospitalRecruiting
- Shizuoka Cancer CenterRecruiting
- Osaka University HospitalRecruiting
- Showa University HospitalRecruiting
- Kanagawa Cancer CenterRecruiting
- National Cancer CenterRecruiting
- Seoul National University Bundang HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- Icaro Investigaciones en MedicinaRecruiting
- Cryptex Investigación ClínicaRecruiting
- Sinacor - Centro para el Desarrollo de la MedicinaRecruiting
- Panamerican Clinical Research Mexico - GuadalajaraRecruiting
- Medical Care and Research S.A. de C.V.Recruiting
- Avix Investigacion Clinica S.C.Recruiting
- Fucam A.C.Recruiting
- Oncológico PotosinoRecruiting
- FAICIC Clínical ResearchRecruiting
- iBiomed - Investigacion Biomedica para el DesarrolRecruiting
- Amphia Ziekenhuis - Breda LangendijkRecruiting
- Universitair Medisch Centrum GroningenRecruiting
- Medisch Centrum LeeuwardenRecruiting
- Maastricht Universitair Medisch CentrumRecruiting
- Erasmus Medisch CentrumRecruiting
- Narodowy Instytut Onkologii im. Marii SklodowskiejRecruiting
- SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza KoszarowskiegoRecruiting
- Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-CurieRecruiting
- Mazowiecki Szpital Wojewódzki im. w. Jana Pawa IIRecruiting
- Wojskowy Instytut MedycznyRecruiting
- Narodowy Instytut Onkologii im.Marii Marii SklodowskiejRecruiting
- Ponce Medical School Foundation Inc.Recruiting
- Clinical Research Puerto RicoRecruiting
- Spitalul Clinic FilantropiaRecruiting
- SC Medisprof SRLRecruiting
- Institutal Oncologic, Prof. Dr Ion ChiricutaRecruiting
- Centrul De Oncologie Sf NectarieRecruiting
- S.C. Oncomed S.R.LRecruiting
- Onkologicky Ustav Sv. AlzbetyRecruiting
- Národný onkologický ústavRecruiting
- Vychodoslovensky onkologicky ustav, a.s., Oddelenie klinickej onkologieRecruiting
- Nemocnica PartizánskeRecruiting
- Hopelands Cancer CentreRecruiting
- Wits Clinical ResearchRecruiting
- The Medical Oncology Centre of RosebankRecruiting
- University of PretoriaRecruiting
- Hospital Teresa Herrera - Materno InfantilRecruiting
- Hospital Universitari DexeusRecruiting
- Hospital Clinic BarcelonaRecruiting
- Hospital Universitari Vall d'HebrónRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Hospital Universitario de BasurtoRecruiting
- Hospital Universitari Arnau de VilanovaRecruiting
- Hospital General Universitario Gregorio MaranonRecruiting
- MD Anderson Cancer Center MadridRecruiting
- Hospital Universitario Fundación Jiménez DíazRecruiting
- Hospital Universitario Virgen de la VictoriaRecruiting
- Hospital General Universitario Morales MeseguerRecruiting
- Hospital Unviersitario Virgen del RocioRecruiting
- Hospital Universitario Virgen MacarenaRecruiting
- Hospital Universitario de CanariasRecruiting
- Hospital Clínico Universitario de ValenciaRecruiting
- Kantonsspital BadenRecruiting
- Kantonsspital Baselland - Standort LiestalRecruiting
- Kantonsspital St.GallenRecruiting
- Kantonsspital WinterthurRecruiting
- Brust-Zentrum AGRecruiting
- E-DA Cancer HospitalRecruiting
- KaohsiungRecruiting
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and WelfareRecruiting
- TaichungRecruiting
- National Cheng Kung University HospitalRecruiting
- Chi Mei Hospital, LioyingRecruiting
- National Taiwan University HospitalRecruiting
- Tri-Service General HospitalRecruiting
- Chang Gung Memorial Hospital, LinkouRecruiting
- Baskent Uni. Dr Turgut Noyan Uyg. ve Aras. MerkeziRecruiting
- Memorial Ankara HastanesiRecruiting
- Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve ARecruiting
- Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma HastanesiRecruiting
- Hacettepe Üniversitesi HastanesiRecruiting
- Trakya Universitesi Tip Fakultesi HastanesiRecruiting
- Istanbul Il Saglik Mudurlugu Goztepe Prof. Dr. SulRecruiting
- Medipol Mega Universite HastanesiRecruiting
- Medicana International Izmir HastanesiRecruiting
- Acibadem Maslak HastanesiRecruiting
- Gloucestershire Hospitals NHS Foundation TrustRecruiting
- Cancer Research UK Beatson InstituteRecruiting
- Leeds Teaching Hospitals NHS TrustRecruiting
- Barts Health NHS TrustRecruiting
- Guy's and Saint Thomas' NHS Foundation TrustRecruiting
- University College London Hospitals NHS FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sacituzumab Govitecan-hziy (SG)
Treatment of Physician's Choice (TPC)
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens: Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle