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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)

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

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.

AlabamaAlabama Oncology, Birmingham
Clearview Cancer Institute, Huntsville
ArizonaPalo Verde Hematology Oncology, Glendale
CaliforniaAlta 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
ConnecticutStamford Hospital, Stamford
District of ColumbiaMedStar Georgetown University Hospital, Washington D.C.
MedStar Washington Hospital Center, Washington D.C.
FloridaCancer 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
GeorgiaUniversity 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
IdahoKootenai Health, Coeur d'Alene
IllinoisNorthwestern Medicine, Chicago
Rush University Medical Center, Chicago
University of Chicago Medical Center, Chicago
NorthShore University Healthsystem, Evanston
Edward Hospital, Naperville
Carle Cancer Center, Urbana
IndianaFranciscan Health Indianapolis, Indianapolis
IowaMission Cancer & Blood - John Stoddard Cancer Center, Des Moines
University of Iowa Hospitals and Clinics, Iowa City
KansasCancer Center of Kansas, Wichita
KentuckyNorton Healthcare, Inc., Louisville
Mercy Health, Paducah
LouisianaMary Bird Perkins Cancer Center, Baton Rouge
University Medical Center - New Orleans, New Orleans
MaineNew England Cancer Specialists, Scarborough
MarylandJohns 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
MassachusettsBeth 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
MichiganCancer and Hematology Centers of Western Michigan, Grand Rapids
William Beaumont Hospital, Royal Oak
MinnesotaMinnesota 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
MissouriWashington University School of Medicine, St Louis
NebraskaNebraska Methodist Hospital (change from Chi Health Bergan Mercy), Omaha
Oncology Hematology West - Methodist, Omaha
New JerseyRegional Cancer Care Associates LLC, East Brunswick
Hunterdon Medical Center, Flemington
Rutgers Health, New Brunswick
Overlook Medical Center, Summit
New MexicoUniversity of New Mexico, Albuquerque
San Juan Oncology Associates, Farmington
New YorkHematology 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 CarolinaLineberger 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
OhioGood Samaritan Hospital, Cincinnati
Oncology Hematology Care, Inc., Cincinnati
Anita Stewart Oncology Center, Columbus
Ohio Health Research Institute, Columbus
Ohio State University CRS, Columbus
OregonSt. 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
PennsylvaniaLancaster 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 IslandProvidence Health, Providence
South CarolinaMedical University of South Carolina, Charleston
St. Francis Cancer Center, Greenville
Spartanburg Medical Center, Spartanburg
South DakotaMonument Health Cancer Care Institute, Rapid City
Avera Cancer Institute, Sioux Falls
TennesseeUniversity of Tennessee, Knoxville
TexasTexas Oncology, Austin
Texas Oncology, El Paso
MD Anderson Cancer Center, Houston
Texas Oncology, San Antonio
UtahHuntsman Cancer Institute, Salt Lake City
VirginiaUniversity of Virginia, Charlottesville
Inova Fairfax Hospital, Fairfax
Bon Secours Cancer Institute at St. Francis, Midlothian
Oncology and Hematology Associates of Southwest Virginia, Inc, Wytheville
WashingtonProvidence Regional Cancer System, Lacey
MultiCare Regional Cancer Center - Tacoma, Puyallup
Northwest Medical Specialties, PLLC, Puyallup
West VirginiaWest Virginia University Hospital, Morgantown
WisconsinAscension 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.