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)

Official title

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan 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

Study identification

NCT ID

NCT05633654

Recruitment status

Recruiting

Study type

Interventional

Phase

Phase 3

Lead sponsor

Gilead Sciences

Industry

Enrollment

1,514 participants

Conditions and interventions

Eligibility (public fields only)

Age range

18 Years and older

Sex

All

Healthy volunteers

Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date

Dec 11, 2022

Primary completion

May 31, 2027

Completion

Jul 31, 2031

Last update posted

Apr 29, 2026

2022 – 2031

United States locations

U.S. sites

184

U.S. states

40

U.S. cities

158

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 155 non-U.S. sites.