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Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

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研究单位: [1]Gilead Sciences [2]Texas Oncology-Denison,Denison,Texas,United States,75020 [3]The Center for Cancer & Blood Disorders - Magnolia,Fort Worth,Texas,United States,76104 [4]Oncology Consultants,1631 North Loop West,Houston,Texas,United States,77008 [5]Oncology Consultants,925 Gessner,Houston,Texas,United States,77024 [6]Oncology Consultants,Houston,Texas,United States,77030 [7]Mays Cancer Center,San Antonio,Texas,United States,78229 [8]The Center for Cancer & Blood Disorders - Magnolia,920 Santa Fe Drive,Weatherford,Texas,United States,76086 [9]Virginia Oncology Associates,744 N. Battlefield Blvd,Chesapeake,Virginia,United States,23320 [10]Virginia Cancer Specialists, PC,7501 Right Flank Road,Mechanicsville,Virginia,United States,23116 [11]Virginia Oncology Associates,1051 Loftis Blvd Suite 100,Newport News,Virginia,United States,23606 [12]Virginia Oncology Associates,Norfolk,Virginia,United States,23502 [13]Virginia Cancer Specialists, PC,210 Medical Park Boulevard,Petersburg,Virginia,United States,23805 [14]Virginia Cancer Specialists, PC,1401 Johnston-Willis Drive,Richmond,Virginia,United States,23235 [15]Virginia Cancer Specialists, PC,Richmond,Virginia,United States,23298 [16]Virginia Oncology Associates,1950 Glenn Mitchell Drive,Virginia Beach,Virginia,United States,23456 [17]Swedish Cancer Institute-First Hill,21632 Highway 99,Edmonds,Washington,United States,98026 [18]Swedish Cancer Institute-First Hill,751 NE Blakely Drive,Issaquah,Washington,United States,98029 [19]Swedish Cancer Institute-First Hill,Seattle,Washington,United States,98104 [20]Swedish Cancer Institute-First Hill,747 Broadway,Seattle,Washington,United States,98122 [21]Northwest Cancer Specialists, P.C,210 SE 136th Avenue,Vancouver,Washington,United States,98684 [22]Hospital Británico de Buenos Aires,Buenos Aires,Argentina,1426 [23]Instituto de Oncologia Angel H.Roffo,Caba,Argentina,1417 [24]Fundacion CORI para la Investigacion y Prevencion del Cancer,Capital,Argentina,F5300COE [25]Instituto de Oncología de Rosario,Rosario,Argentina,2000 [26]Centro para la Atencion Integral del Paciente Oncologico Centro Médico C.A.I.P.O,San Miguel de Tucumán,Argentina,4000 [27]Clinica Viedma,Viedma,Argentina,8500 [28]Border Medical Oncology,Albury,New South Wales,Australia,2640 [29]Saint George Hospital - Australia,Kogarah,New South Wales,Australia,2217 [30]Mater Hospital - North Sydney,North Sydney,New South Wales,Australia,2060 [31]GenesisCare - North Shore,St Leonards,New South Wales,Australia,2065 [32]Mater Misericordiae Limited and Mater Research Limited,South Brisbane,Queensland,Australia,4101 [33]Princess Alexandra Hospital,Woolloongabba,Queensland,Australia,4102 [34]Cancer Research SA (CRSA),Adelaide,South Australia,Australia,5000 [35]Icon Cancer Centre Hobart,Hobart,Tasmania,Australia,7000 [36]Monash Medical Centre,Clayton,Victoria,Australia,3168 [37]Austin Hospital,Melbourne,Victoria,Australia,3084 [38]Breast Cancer Research Center - Western Australia,Nedlands,Western Australia,Australia,6009 [39]Universitätsklinikum Graz,Graz,Austria,8036 [40]Medizinische Universität Innsbruck,Innsbruck,Austria,06020 [41]Ordensklinikum Linz GmbH Barmherzige Schwestern,Linz,Austria,4010 [42]Landeskrankenhaus Salzburg,Salzburg,Austria,A-5020 [43]Universitätsklinikum Sankt Pölten,Sankt Poelten,Austria,3100 [44]Landesklinikum Wiener Neustadt,Wiener Neustadt,Austria,2700 [45]Medizinische Universität Wien,Wien,Austria,1090 [46]Algemeen Ziekenhuis Klina,Brasschaat,Belgium,2930 [47]Cliniques Universitaires Saint-Luc,Brussels,Belgium,1200 [48]Universitair Ziekenhuis Brussel,Brussels,Belgium [49]Grand Hopital de Charleroi - Notre Dame,Charleroi,Belgium,6000 [50]Universitair Ziekenhuis Gent,Gent,Belgium,9000 [51]UZ Leuven,Leuven,Belgium,3000 [52]Centre Hospitalier Universitaire Université Cathol,Namur,Belgium,5000 [53]Hospital Araújo Jorge - Associação de Combate ao Câncer em Goiás - ACCG,Goiânia,Brazil,74605-070 [54]ONCOSITE - Centro de Pesquisa Clinica em Oncologia,Ijui,Brazil,98700-000 [55]Catarina Pesquisa Clínica,Itajai,Brazil,88331-10 [56]Hospital Amaral Carvalho,Jau,Brazil,17210080 [57]Hospital Moinhos de Vento,Porto Alegre,Brazil,90035-00 [58]Hospital de Clinicas de Porto Alegre - HCPA,Porto Alegre,Brazil,90035-903 [59]Hospital Sao Lucas da PUCRS,Porto Alegre,Brazil,90610001 [60]Instituto Nacional de Câncer - INCA - HCIII,Rio de Janeiro,Brazil [61]Núcleo de Oncologia da Bahia,Salvador,Brazil,40170170 [62]CEPHO - Centro de Estudos e PesquisaS de Hematologia e Oncologia,Santo Andre,Brazil,09060-650 [63]Real e Portuguesa de Beneficéncia - Hospital Beneficéncia Portuguesa (BP) - Unidade Paulista,São Paulo,Brazil,01323-001 [64]Clinica de Pesquisas e Centro de Estudos em Oncolo,São Paulo,Brazil,1317000 [65]Fundação Pio XII - Hospital de Amor de Barretos,São Paulo,Brazil,14784400 [66]Nucleo de Pesquisa Clinica da Rede Sao Camilo,São Paulo,Brazil,4014002 [67]Cross Cancer Institute,Edmonton,Canada,T6G 1Z2 [68]QEII Health Sciences Centre,Halifax,Canada,B3H 1V7 [69]Grand River Regional Cancer Centre at Grand River Hospital,Kitchener,Canada,N2G 1G3 [70]London Health Sciences Centre,London,Canada,N6A 5W9 [71]McGill University Health Centre,Montreal,Canada,H4A 3J1 [72]Jewish General Hospital,Montréal,Canada,H3T 1E2 [73]Ottawa Hospital - General Campus,Ottawa,Canada,K1H 8L6 [74]CISSS du Bas-Saint-Laurent - Hôpital régional de Rimouski,Rimouski,Canada,G5L 5T1 [75]Sunnybrook Research Institute,Toronto,Canada,M4N 3M5 [76]Mount Sinai Hospital,Toronto,Canada,M5G 1X5 [77]British Columbia Cancer - Vancouver,Vancouver,Canada,V5Z 4E6 [78]Oncovida - Santiago,Providencia,Chile,7510035 [79]Clínica IRAM,Santiago DE CHILE,Chile [80]Centro de Oncología de Precisión,Santiago Region,Chile,8330032 [81]Clínica Alemana,Santiago,Chile,7630000 [82]James Lind Centro de Investigacion del Cancer,Temuco,Chile [83]Cancer Hospital Chinese Academy of Medical Sciences,Beijing,China,100021 [84]Peking University People's Hospital,Beijing,China,100044 [85]Beijing Cancer Hospital,Beijing,China,100142 [86]The First Medical Center of Chinese PLA General Hospital,Beijing,China,100853 [87]Sichuan Cancer Hospital,Chengdu,China,610041 [88]West China Hospital, Sichuan University,Chengdu,China,610041 [89]Chongqing University Cancer Hospital,Chongqing,China,404100 [90]Deyang People's Hospital,Deyang,China,618000

研究目的:
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

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