Clinical Trial

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Study acronym: ASCENT-03
Active, Not Recruiting Phase 3
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Summary
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.
Protocol Amendment History 31 amendments
This ClinicalTrials.gov record has been amended 31 times since 2022-05-16; most recent amendment 2026-04-03.
Status change: Recruiting → Active, Not Recruiting 2025-09-03
Trial Details
NCT Number NCT05382299
Lead Sponsor Gilead Sciences
Conditions Triple Negative Breast Cancer, PD-L1 Negative
Enrollment 623 participants
Start Date 2022-07-20
Primary Completion 2028-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-06