Home › Triple-Negative Breast Cancer › 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)
RecruitingPhase 3
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Key Inclusion Criteria:
* Age \> 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:
* TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)).
* Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
* Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment.
* Adequate organ function.
Key Exclusion Criteria:
* Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
* Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for \> 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment.
* Evidence of recurrent disease following preoperative therapy and surgery.
* Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
* Individuals with germline breast cancer gene (BRCA) mutations.
* Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of \< 50%
* Active serious infections requiring anti-microbial therapy.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
About the study
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.
What is being tested
- Sacituzumab govitecan-hziy (SG) (drug)
- Pembrolizumab (drug)
- Capecitabine (drug)
Sponsor: Gilead Sciences · Participants: 1,514 · Started: Dec 12, 2022
Contact the study team
Official record on ClinicalTrials.gov — NCT05633654
Locations in the U.S.
| Alabama | Alabama Oncology, Birmingham Clearview Cancer Institute, Huntsville |
| Arizona | Palo Verde Hematology Oncology, Glendale |
| California | Alta Bates Summit Medical Center, Berkeley PIH Health Whittier Hospital, Downey Cedars-Sinai Cancer at Beverly Hills, Los Angeles Hoag Memorial Hospital Presbyterian, Newport Beach Sutter Institute for Medical Research, Sacramento City of Hope (Duarte), San Francisco UCSF Medical Center, San Francisco Sansum Clinic, Santa Barbara Stockton Hematology Oncology Medical Group, Stockton |
| Connecticut | Stamford Hospital, Stamford |
| District of Columbia | MedStar Georgetown University Hospital, Washington D.C. MedStar Washington Hospital Center, Washington D.C. |
| Florida | Cancer Specialists of North Florida, Jacksonville Mayo Clinic Florida, Jacksonville Jupiter Medical Center, Jupiter Mount Sinai Comprehensive Cancer Center, Miami Beach Cancer Care Centers of Brevard, Inc, Palm Bay Memorial Healthcare System, Pembroke Pines Sylvester Comprehensive Cancer Center, Plantation |
| Georgia | University Cancer & Blood Center, LLC., Athens Northside Hospital, Atlanta Piedmont Cancer Institute, Atlanta Northwest Georgia Oncology Centers, PC, Marietta Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta, Newnan Pearlman Cancer Center, Valdosta |
| Idaho | Kootenai Health, Coeur d'Alene |
| Illinois | Northwestern Medicine, Chicago Rush University Medical Center, Chicago University of Chicago Medical Center, Chicago NorthShore University Healthsystem, Evanston Edward Hospital, Naperville Carle Cancer Center, Urbana |
| Indiana | Franciscan Health Indianapolis, Indianapolis |
| Iowa | Mission Cancer & Blood - John Stoddard Cancer Center, Des Moines University of Iowa Hospitals and Clinics, Iowa City |
| Kansas | Cancer Center of Kansas, Wichita |
| Kentucky | Norton Healthcare, Inc., Louisville Mercy Health, Paducah |
| Louisiana | Mary Bird Perkins Cancer Center, Baton Rouge University Medical Center - New Orleans, New Orleans |
| Maine | New England Cancer Specialists, Scarborough |
| Maryland | Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center, Baltimore Sinai Hospital of Baltimore, Inc., Baltimore St. Agnes Hospital, Baltimore James M Stockman Cancer Institute, Frederick Greater Baltimore Medical Center, Towson |
| Massachusetts | Beth Israel Deaconess Medical Center, Boston Dana Farber Cancer Institute, Boston Massachusetts General Hospital, Boston Dana-Farber Cancer Institute @Foxborough, Foxborough Dana-Farber Cancer Institude at Merrimack Valley, Methuen Dana Farber Cancer Institute @ Milford Regional Hospital, Milford Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital, South Weymouth |
| Michigan | Cancer and Hematology Centers of Western Michigan, Grand Rapids William Beaumont Hospital, Royal Oak |
| Minnesota | Minnesota Oncology Hematology, PA, Maplewood University of Minnesota Medical Center, Fairview, Minneapolis Virginia Piper Cancer Center (Allina Health), Minneapolis Mayo Clinic Rochester, Rochester Metro Minnesota Community Oncology, Saint Louis Park |
| Missouri | Washington University School of Medicine, St Louis |
| Nebraska | Nebraska Methodist Hospital (change from Chi Health Bergan Mercy), Omaha Oncology Hematology West - Methodist, Omaha |
| New Jersey | Regional Cancer Care Associates LLC, East Brunswick Hunterdon Medical Center, Flemington Rutgers Health, New Brunswick Overlook Medical Center, Summit |
| New Mexico | University of New Mexico, Albuquerque San Juan Oncology Associates, Farmington |
| New York | Hematology Oncology Associates of Central New York, PC, East Syracuse Northwell Health, Lake Success Laura and Isaac Perlmutter Cancer Canter, New York Lipson Cancer Institute - Linden Oaks, Rochester New York Cancer and Blood Specialists, Shirley Stony Brook Medicine, Stony Brook SUNY Upstate Medical University, Syracuse White Plains Hospital Physician Associates, White Plains |
| North Carolina | Lineberger Comprehensive Cancer Center, Chapel Hill Novant Health Cancer Institute - Elizabeth (Breast), Charlotte Duke Cancer Institute, Durham Cone Health Medical Group (Moses Cone Health System), Greensboro Atrium Health Wake Forest Baptist, Winston-Salem |
| Ohio | Good Samaritan Hospital, Cincinnati Oncology Hematology Care, Inc., Cincinnati Anita Stewart Oncology Center, Columbus Ohio Health Research Institute, Columbus Ohio State University CRS, Columbus |
| Oregon | St. Charles Health System, Inc. DBA St. Charles Medical Center, Bend Samaritan Hospital, Corvallis Willamette Valley Cancer Institute and Research Center, Eugene Oregon Health & Science University, Portland |
| Pennsylvania | Lancaster General Health, Lancaster University of Pennsylvania Abramson Cancer Center, Philadelphia UPMC Magee-Womens Hospital, Pittsburgh Guthrie Clinical Research, Sayre Lankenau Medical Center, Wynnewood Cancer Care Associates of York, York |
| Rhode Island | Providence Health, Providence |
| South Carolina | Medical University of South Carolina, Charleston St. Francis Cancer Center, Greenville Spartanburg Medical Center, Spartanburg |
| South Dakota | Monument Health Cancer Care Institute, Rapid City Avera Cancer Institute, Sioux Falls |
| Tennessee | University of Tennessee, Knoxville |
| Texas | Texas Oncology, Austin Texas Oncology, El Paso MD Anderson Cancer Center, Houston Texas Oncology, San Antonio |
| Utah | Huntsman Cancer Institute, Salt Lake City |
| Virginia | University of Virginia, Charlottesville Inova Fairfax Hospital, Fairfax Bon Secours Cancer Institute at St. Francis, Midlothian Oncology and Hematology Associates of Southwest Virginia, Inc, Wytheville |
| Washington | Providence Regional Cancer System, Lacey MultiCare Regional Cancer Center - Tacoma, Puyallup Northwest Medical Specialties, PLLC, Puyallup |
| West Virginia | West Virginia University Hospital, Morgantown |
| Wisconsin | Ascension St. Francis Reiman Cancer Center, Franklin |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.