A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
Key Inclusion Criteria:
Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Demonstrates adequate organ function
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
Individuals with 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.
Hot Springs, Arkansas 71914, United States
Burbank, California 91505, United States
Costa Mesa, California 92627, 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
Santa Rosa, California 95403, United States
Westlake Village, California 91361, United States
Altamonte Springs, Florida 32701, United States
Aventura, Florida 33180, United States
Bonita Springs, Florida 34135, United States
Brandon, Florida 33511, United States
Clearwater, Florida 33761, United States
Coral Gables, Florida 33146, United States
Daytona Beach, Florida 32117, United States
Deerfield Beach, Florida 33442, United States
Gainesville, Florida 32605, United States
Hollywood, Florida 33021, United States
Largo, Florida 33770, United States
Lecanto, Florida 34461, United States
Miami, Florida 33136, United States
Miami, Florida 33176, United States
Ocala, Florida 34474, United States
Orange City, Florida 32763, United States
Orlando, Florida 32806, United States
Plantation, Florida 33324, United States
Spring Hill, Florida 34608, United States
St. Petersburg, Florida 33705, United States
Stuart, Florida 34994, United States
Tampa, Florida 33607, United States
Tavares, Florida 32778, United States
The Villages, Florida 32159, United States
Trinity, Florida 34655, United States
Vero Beach, Florida 32960, United States
Wellington, Florida 33414, United States
Winter Park, Florida 32789, United States
Atlanta, Georgia 30308, United States
Atlanta, Georgia 30342, United States
Stockbridge, Georgia 30281, United States
Chicago, Illinois 60611, United States
Chicago, Illinois 60612, United States
Chicago, Illinois 60657, United States
DeKalb, Illinois 60115, United States
DeKalb, Illinois 60115, United States
Evanston, Illinois 60202, 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
Overland Park, Kansas 66210, United States
Louisville, Kentucky 40202, United States
Louisville, Kentucky 40202, United States
Louisville, Kentucky 40241, United States
Zachary, Louisiana 70791, United States
Southaven, Mississippi 38671, United States
Kansas City, Missouri 64116, United States
Kansas City, Missouri 64154, United States
Lee's Summit, Missouri 64064, United States
Henderson, Nevada 89052, United States
Henderson, Nevada 89052, United States
Henderson, Nevada 89074, United States
Las Vegas, Nevada 89144, United States
Las Vegas, Nevada 89148, United States
Las Vegas, Nevada 89169, United States
Livingston, New Jersey 07039, United States
Monroe, New Jersey 08831, United States
New Brunswick, New Jersey 08820, United States
Somerset, New Jersey 08873, United States
Toms River, New Jersey 08755, United States
West Long Branch, New Jersey 07764, United States
Babylon, New York 11702, United States
Mineola, New York 11501, United States
New Hyde Park, New York 11042, United States
New York, New York 10032, 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
Columbus, Ohio 43212, United States
Cranberry Township, Pennsylvania 16066, United States
Arlington, Texas 76104, United States
Burleson, Texas 76028, United States
Weatherford, Texas 76086, United States
Farmington, Utah 84025, United States
Salt Lake City, Utah 84106, United States
South Jordan, Utah 84009, United States
CABA, 1417, Argentina
Capital, F5300COE, Argentina
Jaú, 17210080, Brazil
Santo André, 09060-650, Brazil
São Paulo, 01323-001, Brazil
Ontario, M5G 2M9, Canada
Santiago Region, 8330032, Chile
Prague, 100 34, Czechia
Mönchengladbach, 41061, Germany
Münster, 48149, Germany
Bologna, Italy
Genova GE, 16132, Italy
Naples, 80131, Italy
Aoba-ku, 980-8574, Japan
Ehime, 791-0280, Japan
Inamachi, 362-0806, Japan
Sakyo-ku, 606-8507, Japan
Sarawak, 93586, Malaysia
Goyang-si Gyeonggi-do, 10408, South Korea
Ankara, 6200, Turkey (Türkiye)