Breast Cancer Clinical Trial
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician’s Choice in Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Summary
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.
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.
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There are 36 Locations for this study
Anchorage Alaska, 99508, United States
Tucson Arizona, 85711, United States
Hot Springs Arkansas, 71913, United States
Santa Barbara California, 93105, United States
Boulder Colorado, 80303, United States
Norwich Connecticut, 06360, United States
Altamonte Springs Florida, 32701, United States
Fort Myers Florida, 33901, United States
Saint Petersburg Florida, 33705, United States
West Palm Beach Florida, 33401, United States
Atlanta Georgia, 30318, United States
Atlanta Georgia, 30342, United States
Marietta Georgia, 30060, United States
Skokie Illinois, 60077, United States
Baton Rouge Louisiana, 70809, United States
Omaha Nebraska, 68130, United States
Florham Park New Jersey, 07932, United States
New Brunswick New Jersey, 08901, United States
East Syracuse New York, 13057, United States
Columbus Ohio, 43219, United States
Tigard Oregon, 97223, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78731, United States
Dallas Texas, 75246, United States
Denison Texas, 75020, United States
Houston Texas, 77030, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23298, United States
Nantes , 44202, France
Ponce , 00732, Puerto Rico
San Juan , 00909, Puerto Rico
Barcelona , 8041, Spain
Sevilla , 41071, Spain
Liestal , 4410, Switzerland
St. Gallen , 9007, Switzerland
Zürich , 8008, Switzerland
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