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About
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC).
The primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).
Full description
Phase 1 of this study will evaluate the preliminary safety, tolerability, pharmacokinetics (PK), and efficacy of SG. Phase 2 expansion of this study will further evaluate the safety, efficacy, and PK of SG.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
During Phase 1 safety run-in, individuals must be UGT1A1 wild-type.
After Phase 1 safety run-in, individuals with any UGT1A1 genotype may be eligible.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria will apply.
Primary purpose
Allocation
Interventional model
Masking
100 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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