A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
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.
Key Inclusion Criteria:
Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
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:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Burbank, California 91505, United States
Laguna Hills, California 91505, United States
San Luis Obispo, California 93401, United States
Santa Monica, California 90404, United States
Santa Monica, California 90404, United States
Santa Monica, California 90404, United States
Westlake Village, California 91361, United States
Altamonte Springs, Florida 32701, United States
Bonita Springs, Florida 34135, United States
Brandon, Florida 33511, United States
Clearwater, Florida 33761, United States
Gainesville, Florida 32605, United States
Largo, Florida 33770, United States
Lecanto, Florida 34461, United States
Ocala, Florida 34474, United States
Orange City, Florida 32763, United States
Orlando, Florida 32806, United States
Spring Hill, Florida 34608, United States
St. Petersburg, Florida 33705, United States
St. Petersburg, Florida 33705, United States
Tampa, Florida 33607, United States
Tavares, Florida 32778, United States
The Villages, Florida 32159, United States
Trinity, Florida 34655, United States
Winter Park, Florida 32789, United States
Carrollton, Georgia 30117, United States
Cartersville, Georgia 30121, United States
Marietta, Georgia 30060, United States
Chicago, Illinois 60611, United States
DeKalb, Illinois 60115, United States
DeKalb, Illinois 60115, United States
Geneva, Illinois 60134, United States
Geneva, Illinois 60134, United States
Lake Forest, Illinois 60045, United States
Warrenville, Illinois 25731, United States
Warrenville, Illinois 60555, United States
Winfield, Illinois 60190, United States
Louisville, Kentucky 40202, United States
Louisville, Kentucky 40202, United States
Louisville, Kentucky 40241, United States
Southaven, Mississippi 38671, United States
Babylon, New York 11702, United States
New Hyde Park, New York 11042, United States
Patchogue, New York 11772, United States
Port Jefferson, New York 11776, United States
Port Jefferson Station, New York 11776, United States
Port Jefferson Station, New York 11776, United States
Riverhead, New York 11901, United States
The Bronx, New York 10028, United States
The Bronx, New York 10469, United States
Charlotte, North Carolina 28204, United States
Wilmington, North Carolina 28401, United States
Mechanicsburg, Pennsylvania 17050, United States
CABA, 1417, Argentina
Capital, F5300COE, Argentina
San Miguel de Tucumán, 4000, Argentina
São Paulo, 01323-001, Brazil
Santiago Region, 8330032, Chile
Jilin Sheng, 130041, China
Wuhan, 430022, China
Wuhan, 430030, China
Prague, 100 34, Czechia
Bologna, Italy
Genova GE, 16132, Italy
Naples, 80131, Italy
Ehime, 791-0280, Japan
Sakyo-ku, 606-8507, Japan
Sarawak, 93586, Malaysia
Goyang-si Gyeonggi-do, 10408, South Korea
Taipei, 104217, Taiwan