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 now · Phase 3
Conditions studied: Triple Negative Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT05633654
- Run by
- Gilead Sciences
- People needed
- 1514
- Starts
- 2022-12-12
- Expected to finish
- 2031-08-01
- Last updated by the study team
- 2026-07-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States (enrolling)
- Sylvester Comprehensive Cancer Center — Plantation, Florida, United States (enrolling)
- Clearview Cancer Institute — Huntsville, Alabama, United States (enrolling)
- Jupiter Medical Center — Jupiter, Florida, United States (enrolling)
- Cancer Care Centers of Brevard, Inc — Palm Bay, Florida, United States (enrolling)
- Memorial Healthcare System — Pembroke Pines, Florida, United States (enrolling)
- PIH Health Whittier Hospital — Downey, California, United States (enrolling)
- Compassionate Cancer Care Medical Group - Inc — Fountain Valley, California, United States (enrolling)
- Cancer Specialists of North Florida — Jacksonville, Florida, United States (enrolling)
- Alabama Oncology — Birmingham, Alabama, United States (enrolling)
- Alta Bates Summit Medical Center — Berkeley, California, United States (enrolling)
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
- Palo Verde Hematology Oncology — Glendale, Arizona, United States (enrolling)
- Sutter Institute for Medical Research — Sacramento, California, United States (enrolling)
- City of Hope (Duarte) — San Francisco, California, United States (enrolling)
- UCSF Medical Center — San Francisco, California, United States (enrolling)
- Sansum Clinic — Santa Barbara, California, United States (enrolling)
- Stockton Hematology Oncology Medical Group — Stockton, California, United States (enrolling)
- Los Angeles Cancer Network — Los Angeles, California, United States (enrolling)
- Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
- Stamford Hospital — Stamford, Connecticut, United States (enrolling)
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
- Cedars-Sinai Cancer at Beverly Hills — Los Angeles, California, United States (enrolling)
- University Cancer & Blood Center, LLC. — Athens, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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