Algemeen Ziekenhuis Klina | Cardiology Department
Status and phase
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About
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).
Enrollment
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Inclusion and exclusion criteria
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.
Primary purpose
Allocation
Interventional model
Masking
443 participants in 2 patient groups
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Central trial contact
Gilead Clinical Study Information Center
Data sourced from clinicaltrials.gov
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