ASCENT 04 - GS-US-592-6173

Breast cancer

Inclusion

• 8 Years and older 
• 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 as defined in the protocol

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 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.

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).

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