NCT05633654

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)

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,514 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab govitecan-hziy (SG)	Administered intravenously
DRUG	Pembrolizumab	Administered intravenously
DRUG	Capecitabine	Tablets administered orally

Timeline

• Start date: 2022-12-12
• Primary completion: 2027-06-01
• Completion: 2031-08-01
• First posted: 2022-12-01
• Last updated: 2026-01-20

Locations

288 sites across 8 countries: United States, Australia, France, Germany, Ireland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study