Actively Recruiting
Phase 12 Study of Sacituzumab Govitecan Given at a New Dose and Schedule for Advanced Triple-Negative Breast Cancer
Led by Gilead Sciences · Updated on 2026-01-30
100
Participants Needed
16
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the study drug sacituzumab govitecan-hziy SG given at an alternative dose and schedule in participants with advanced triple-negative breast cancer TNBC. The study aims to assess the safety, tolerability, and effects on tumor response and progression-free survival. This trial includes Phase 1 and Phase 2 stages to explore both preliminary and expanded safety and efficacy of SG. During Phase 1, participants receive SG intravenously to evaluate initial safety, tolerability, pharmacokinetics, and early efficacy. Phase 2 expansion continues the evaluation of safety, efficacy, and pharmacokinetics with the alternative dosing schedule. Participants will receive SG until their disease progresses, unacceptable side effects occur, or other discontinuation reasons arise. Participants will be monitored through various assessments including imaging scans to measure tumor response, blood tests for safety and drug levels, and tracking of side effects and treatment tolerability. The main outcomes measured include dose-limiting toxicities, adverse events, laboratory abnormalities, objective response rate, and progression-free survival over up to nine months. Safety and drug concentration data will be collected for up to three years, supporting long-term evaluation.
CONDITIONS
Brief Title
A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
Research Team
G
Gilead Clinical Study Information Center
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