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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)
Sponsor: Gilead Sciences
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1514
Start Date
2022-12-12
Completion Date
2031-08
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Sacituzumab govitecan-hziy (SG)
Administered intravenously
Pembrolizumab
Administered intravenously
Capecitabine
Tablets administered orally
Locations (376)
Alabama Oncology
Birmingham, Alabama, United States
Clearview Cancer Institute
Huntsville, Alabama, United States
Palo Verde Hematology Oncology
Glendale, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Arizona Oncology Associates
Prescott Valley, Arizona, United States
Alta Bates Summit Medical Center
Berkeley, California, United States
Community Cancer Institute
Clovis, California, United States
PIH Health Whittier Hospital
Downey, California, United States
Compassionate Cancer Care Medical Group - Inc
Fountain Valley, California, United States
Los Angeles Cancer Network
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Cedars-Sinai Cancer at Beverly Hills
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Emad Ibrahim, MD, INC
Redlands, California, United States
Sutter Institute for Medical Research
Sacramento, California, United States
City of Hope (Duarte)
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
Sansum Clinic
Santa Barbara, California, United States
Stockton Hematology Oncology Medical Group
Stockton, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Norwalk Hospital
Danbury, Connecticut, United States
Stamford Hospital
Stamford, Connecticut, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Morton Plant Hospital - Bay Care
Clearwater, Florida, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Midland Florida Clinical Research Center, L
Orange City, Florida, United States
Orlando Health
Orlando, Florida, United States
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, United States
Memorial Healthcare System
Pembroke Pines, Florida, United States
Sacred Heart Medical Oncology Group
Pensacola, Florida, United States
Sylvester Comprehensive Cancer Center
Plantation, Florida, United States
Cleveland Clinic Florida, Martin North Hospital
Stuart, Florida, United States
St. Joseph's Hospital
Tampa, Florida, United States
Weston Hospital
Weston, Florida, United States
University Cancer & Blood Center, LLC.
Athens, Georgia, United States
Piedmont Cancer Institute
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States
Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
Newnan, Georgia, United States
Pearlman Cancer Center
Valdosta, Georgia, United States
St Lukes Mountain States Tumor Institute
Boise, Idaho, United States
Kootenai Health
Coeur d'Alene, Idaho, United States
Northwestern Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
NorthShore University Healthsystem
Evanston, Illinois, United States
Edward Hospital
Naperville, Illinois, United States
West Suburban Medical Center- River Forest
River Forest, Illinois, United States
Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
Skokie, Illinois, United States
Springfield Clinic LLP
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, United States
IU Health Arnett Hospital
Lafayette, Indiana, United States
Franciscan Health Munster
Munster, Indiana, United States
Mercy Medical Center
Cedar Rapids, Iowa, United States
Mission Cancer & Blood - John Stoddard Cancer Center
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Cancer Center of Kansas
Wichita, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Norton Healthcare, Inc.
Louisville, Kentucky, United States
Mercy Health
Paducah, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
University Medical Center - New Orleans
New Orleans, Louisiana, United States
New England Cancer Specialists
Scarborough, Maine, United States
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland, United States
St. Agnes Hospital
Baltimore, Maryland, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
James M Stockman Cancer Institute
Frederick, Maryland, United States
Greater Baltimore Medical Center
Towson, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber Cancer Institute @Foxborough
Foxborough, Massachusetts, United States
Dana-Farber Cancer Institude at Merrimack Valley
Methuen, Massachusetts, United States
Dana Farber Cancer Institute @ Milford Regional Hospital
Milford, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
South Weymouth, Massachusetts, United States
Baystate Medical Center Inc.
Springfield, Massachusetts, United States
University of Massachusetts Worcester
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Ascension
Grosse Pointe Woods, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Ascension Providence Hospital Southfield Cancer Center
Southfield, Michigan, United States
Trinity Health St. Joseph Mercy Ann Arbor
Ypsilanti, Michigan, United States
Minnesota Oncology Hematology, PA
Maplewood, Minnesota, United States
Virginia Piper Cancer Center (Allina Health)
Minneapolis, Minnesota, United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Metro Minnesota Community Oncology
Saint Louis Park, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States