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)
NCT05633654
This study is recruiting at 122 US sites in 38 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Triple Negative Breast Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Gilead Sciences
- Last updated on ClinicalTrials.gov
- October 13, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 2
- Alabama Oncology · Birmingham, AL
- Clearview Cancer Institute · Huntsville, AL
Arizona · 1
- Palo Verde Hematology Oncology · Glendale, AZ
California · 9
- Alta Bates Summit Medical Center · Berkeley, CA
- PIH Health Whittier Hospital · Downey, CA
- Cedars-Sinai Cancer at Beverly Hills · Los Angeles, CA
- Hoag Memorial Hospital Presbyterian · Newport Beach, CA
- Sutter Institute for Medical Research · Sacramento, CA
- City of Hope (Duarte) · San Francisco, CA
- UCSF Medical Center · San Francisco, CA
- Sansum Clinic · Santa Barbara, CA
- Stockton Hematology Oncology Medical Group · Stockton, CA
Connecticut · 1
- Stamford Hospital · Stamford, CT
District of Columbia · 2
- MedStar Georgetown University Hospital · Washington D.C., DC
- MedStar Washington Hospital Center · Washington D.C., DC
Florida · 7
- Cancer Specialists of North Florida · Jacksonville, FL
- Mayo Clinic Florida · Jacksonville, FL
- Jupiter Medical Center · Jupiter, FL
- Mount Sinai Comprehensive Cancer Center · Miami Beach, FL
- Cancer Care Centers of Brevard, Inc · Palm Bay, FL
- Memorial Healthcare System · Pembroke Pines, FL
- Sylvester Comprehensive Cancer Center · Plantation, FL
Georgia · 6
- University Cancer & Blood Center, LLC. · Athens, GA
- Northside Hospital · Atlanta, GA
- Piedmont Cancer Institute · Atlanta, GA
- Northwest Georgia Oncology Centers, PC · Marietta, GA
- Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta · Newnan, GA
- Pearlman Cancer Center · Valdosta, GA
Idaho · 1
- Kootenai Health · Coeur d'Alene, ID
Illinois · 6
- Northwestern Medicine · Chicago, IL
- Rush University Medical Center · Chicago, IL
- University of Chicago Medical Center · Chicago, IL
- NorthShore University Healthsystem · Evanston, IL
- Edward Hospital · Naperville, IL
- Carle Cancer Center · Urbana, IL
Indiana · 1
- Franciscan Health Indianapolis · Indianapolis, IN
Iowa · 2
- Mission Cancer & Blood - John Stoddard Cancer Center · Des Moines, IA
- University of Iowa Hospitals and Clinics · Iowa City, IA
Kansas · 1
- Cancer Center of Kansas · Wichita, KS
Kentucky · 2
- Norton Healthcare, Inc. · Louisville, KY
- Mercy Health · Paducah, KY
Louisiana · 2
- Mary Bird Perkins Cancer Center · Baton Rouge, LA
- University Medical Center - New Orleans · New Orleans, LA
Maine · 1
- New England Cancer Specialists · Scarborough, ME
Maryland · 5
- Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center · Baltimore, MD
- Sinai Hospital of Baltimore, Inc. · Baltimore, MD
- St. Agnes Hospital · Baltimore, MD
- James M Stockman Cancer Institute · Frederick, MD
- Greater Baltimore Medical Center · Towson, MD
Massachusetts · 8
- Beth Israel Deaconess Medical Center · Boston, MA
- Dana Farber Cancer Institute · Boston, MA
- Massachusetts General Hospital · Boston, MA
- Tufts Medical Center · Boston, MA
- Dana-Farber Cancer Institute @Foxborough · Foxborough, MA
- Dana-Farber Cancer Institude at Merrimack Valley · Methuen, MA
- Dana Farber Cancer Institute @ Milford Regional Hospital · Milford, MA
- Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital · South Weymouth, MA
Michigan · 2
- Cancer and Hematology Centers of Western Michigan · Grand Rapids, MI
- William Beaumont Hospital · Royal Oak, MI
Minnesota · 5
- Minnesota Oncology Hematology, PA · Maplewood, MN
- University of Minnesota Medical Center, Fairview · Minneapolis, MN
- Virginia Piper Cancer Center (Allina Health) · Minneapolis, MN
- Mayo Clinic Rochester · Rochester, MN
- Metro Minnesota Community Oncology · Saint Louis Park, MN
Missouri · 1
- Washington University School of Medicine · St Louis, MO
Nebraska · 2
- Nebraska Methodist Hospital (change from Chi Health Bergan Mercy) · Omaha, NE
- Oncology Hematology West - Methodist · Omaha, NE
New Jersey · 4
- Regional Cancer Care Associates LLC · East Brunswick, NJ
- Hunterdon Medical Center · Flemington, NJ
- Rutgers Health · New Brunswick, NJ
- Overlook Medical Center · Summit, NJ
New Mexico · 2
- University of New Mexico · Albuquerque, NM
- San Juan Oncology Associates · Farmington, NM
New York · 8
- Hematology Oncology Associates of Central New York, PC · East Syracuse, NY
- Northwell Health · Lake Success, NY
- Laura and Isaac Perlmutter Cancer Canter · New York, NY
- Lipson Cancer Institute - Linden Oaks · Rochester, NY
- New York Cancer and Blood Specialists · Shirley, NY
- Stony Brook Medicine · Stony Brook, NY
- SUNY Upstate Medical University · Syracuse, NY
- White Plains Hospital Physician Associates · White Plains, NY
North Carolina · 5
- Lineberger Comprehensive Cancer Center · Chapel Hill, NC
- Novant Health Cancer Institute - Elizabeth (Breast) · Charlotte, NC
- Duke Cancer Institute · Durham, NC
- Cone Health Medical Group (Moses Cone Health System) · Greensboro, NC
- Atrium Health Wake Forest Baptist · Winston-Salem, NC
Ohio · 5
- Good Samaritan Hospital · Cincinnati, OH
- Oncology Hematology Care, Inc. · Cincinnati, OH
- Anita Stewart Oncology Center · Columbus, OH
- Ohio Health Research Institute · Columbus, OH
- Ohio State University CRS · Columbus, OH
Oregon · 4
- St. Charles Health System, Inc. DBA St. Charles Medical Center · Bend, OR
- Samaritan Hospital · Corvallis, OR
- Willamette Valley Cancer Institute and Research Center · Eugene, OR
- Oregon Health & Science University · Portland, OR
Pennsylvania · 6
- Lancaster General Health · Lancaster, PA
- University of Pennsylvania Abramson Cancer Center · Philadelphia, PA
- UPMC Magee-Womens Hospital · Pittsburgh, PA
- Guthrie Clinical Research · Sayre, PA
- Lankenau Medical Center · Wynnewood, PA
- Cancer Care Associates of York · York, PA
Rhode Island · 1
- Providence Health · Providence, RI
South Carolina · 3
- Medical University of South Carolina · Charleston, SC
- St. Francis Cancer Center · Greenville, SC
- Spartanburg Medical Center · Spartanburg, SC
South Dakota · 2
- Monument Health Cancer Care Institute · Rapid City, SD
- Avera Cancer Institute · Sioux Falls, SD
Tennessee · 1
- University of Tennessee · Knoxville, TN
Texas · 4
- Texas Oncology · Austin, TX
- Texas Oncology · El Paso, TX
- MD Anderson Cancer Center · Houston, TX
- Texas Oncology · San Antonio, TX
Utah · 1
- Huntsman Cancer Institute · Salt Lake City, UT
Virginia · 4
- University of Virginia · Charlottesville, VA
- Inova Fairfax Hospital · Fairfax, VA
- Bon Secours Cancer Institute at St. Francis · Midlothian, VA
- Oncology and Hematology Associates of Southwest Virginia, Inc · Wytheville, VA
Washington · 3
- Providence Regional Cancer System · Lacey, WA
- MultiCare Regional Cancer Center - Tacoma · Puyallup, WA
- Northwest Medical Specialties, PLLC · Puyallup, WA
West Virginia · 1
- West Virginia University Hospital · Morgantown, WV
Wisconsin · 1
- Ascension St. Francis Reiman Cancer Center · Franklin, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.