Overview
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).
Eligibility
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.
- Individuals must have completed treatment for Stage I to 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 for this study.
- TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
- Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
- 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:
- Positive serum pregnancy test or women who are lactating.
- Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor.
- Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment.
- Individuals 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.
- Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.
- Have an active second malignancy.
- Have active serious infection requiring antibiotics.
- Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.