Sacituzumab Govitecan for Breast Cancer
Trial Summary
What is the purpose of this trial?
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).
Research Team
Gilead Study Director
Principal Investigator
Gilead Sciences
Eligibility Criteria
This trial is for adults with advanced triple-negative breast cancer (TNBC) who have tried at least one chemotherapy or systemic therapy. For phase 2, tumors must be PD-L1 negative or ineligible for anti-PD-(L)1 treatment due to other health issues. Participants need measurable disease and a good performance status score.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Participants receive sacituzumab govitecan until progressive disease, death, or unacceptable toxicity
Phase 2 Treatment
Further evaluation of safety, efficacy, and pharmacokinetics of sacituzumab govitecan
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Sacituzumab Govitecan-hziy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gilead Sciences
Lead Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine