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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Sacituzumab govitecan-hziy (SG): Administered intravenously
Pembrolizumab: Administered intravenously
Capecitabine: Tablets administered orally
Study 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.
Eligibility
Primary outcome measure(s)
- Invasive Disease-free Survival (iDFS) — Up to 60 months
iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer.
Trial sites (372)
| Facility | City | Region | Status |
|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | Recruiting |
| Clearview Cancer Institute | Huntsville | Alabama | Recruiting |
| Palo Verde Hematology Oncology | Glendale | Arizona | Recruiting |
| Mayo Clinic Hospital | Phoenix | Arizona | Withdrawn |
| Arizona Oncology Associates | Prescott Valley | Arizona | Withdrawn |
| Alta Bates Summit Medical Center | Berkeley | California | Recruiting |
| Community Cancer Institute | Clovis | California | Withdrawn |
| PIH Health Whittier Hospital | Downey | California | Recruiting |
| Compassionate Cancer Care Medical Group - Inc | Fountain Valley | California | Active Not Recruiting |
| Los Angeles Cancer Network | Los Angeles | California | Active Not Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | Withdrawn |
| Cedars-Sinai Cancer at Beverly Hills | Los Angeles | California | Recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | Recruiting |
| Emad Ibrahim, MD, INC | Redlands | California | Withdrawn |
| Sutter Institute for Medical Research | Sacramento | California | Recruiting |
| City of Hope (Duarte) | San Francisco | California | Recruiting |
| UCSF Medical Center | San Francisco | California | Recruiting |
| Sansum Clinic | Santa Barbara | California | Recruiting |
| Stockton Hematology Oncology Medical Group | Stockton | California | Recruiting |
| University of Colorado Cancer Center | Aurora | Colorado | Withdrawn |
| Norwalk Hospital | Danbury | Connecticut | Withdrawn |
| Stamford Hospital | Stamford | Connecticut | Recruiting |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | Recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | Recruiting |
| Morton Plant Hospital - Bay Care | Clearwater | Florida | Withdrawn |
| University of Florida | Gainesville | Florida | Withdrawn |
| Mayo Clinic Florida | Jacksonville | Florida | Recruiting |
| Cancer Specialists of North Florida | Jacksonville | Florida | Recruiting |
| Jupiter Medical Center | Jupiter | Florida | Recruiting |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | Recruiting |
| Midland Florida Clinical Research Center, L | Orange City | Florida | Withdrawn |
| Orlando Health | Orlando | Florida | Active Not Recruiting |
| Cancer Care Centers of Brevard, Inc | Palm Bay | Florida | Recruiting |
| Memorial Healthcare System | Pembroke Pines | Florida | Recruiting |
| Sacred Heart Medical Oncology Group | Pensacola | Florida | Withdrawn |
| Sylvester Comprehensive Cancer Center | Plantation | Florida | Recruiting |
| Cleveland Clinic Florida, Martin North Hospital | Stuart | Florida | Withdrawn |
| St. Joseph's Hospital | Tampa | Florida | Withdrawn |
| Weston Hospital | Weston | Florida | Withdrawn |
| University Cancer & Blood Center, LLC. | Athens | Georgia | Recruiting |
+ 332 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Gilead Sciences trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05633654 on ClinicalTrials.gov ↗ ← All trials in France