Clinical Trial

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
Protocol Amendment History 3 changes
notable Trial sites expanded: 350 -> 356 locations 2026-07-16
notable Trial sites expanded: 339 -> 350 locations 2026-06-11
notable Trial sites expanded: 288 -> 339 locations 2026-05-01
Trial Details
NCT Number NCT05633654
Lead Sponsor Gilead Sciences
Collaborators: Alliance Foundation Trials, LLC., NSABP Foundation Inc, GBG Forschungs GmbH
Conditions Triple Negative Breast Cancer
Enrollment 1,514 participants
Start Date 2022-12-12
Primary Completion 2027-06 (estimated)
Study Completion 2031-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-15