Recruiting

Phase 3

Sacituzumab Govitecan-hziy & PembrolizumabStudy 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

Code:

NCT05633654

Conditions

Triple Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab govitecan-hziy (SG)

Pembrolizumab

Capecitabine

Study Details

Brief 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.

Conditions

Triple Negative Breast Cancer

Study ID

NCT05633654

Start date

Dec 12, 2022

Status verified date

Jul, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1514 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sacituzumab govitecan-hziy (SG) + Pembrolizumab

Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles.

Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.

active comparator: Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine

Participants will receive one of the following TPC regimens determined prior to randomization:

Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles OR
Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles and capecitabine 1000 mg/m\^2 orally twice daily on Days 1 through 14 of 21-day cycles for 8 cycles.

Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.

Interventions

Sacituzumab govitecan-hziy (SG)

Administered intravenously

Pembrolizumab

Administered intravenously

Capecitabine

Tablets administered orally

Primary outcome measure

Invasive Disease-free Survival (iDFS) [ Time Frame: Up to 60 months ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

Alabama Oncology

Recruiting

Birmingham, Alabama, United States, 35243

Clearview Cancer Institute

Recruiting

Huntsville, Alabama, United States, 35805

Palo Verde Hematology Oncology

Recruiting

Glendale, Arizona, United States, 85304

Alta Bates Summit Medical Center

Recruiting

Berkeley, California, United States, 94704

PIH Health Whittier Hospital

Recruiting

Downey, California, United States, 90241

Compassionate Cancer Care Medical Group - Inc

Recruiting

Fountain Valley, California, United States, 92708

Los Angeles Cancer Network

Recruiting

Los Angeles, California, United States, 90017

Cedars-Sinai Cancer at Beverly Hills

Recruiting

Los Angeles, California, United States, 90048

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Sutter Institute for Medical Research

Recruiting

Sacramento, California, United States, 95816

City of Hope (Duarte)

Recruiting

San Francisco, California, United States, 94143

UCSF Medical Center

Recruiting

San Francisco, California, United States, 94143

Sansum Clinic

Recruiting

Santa Barbara, California, United States, 93105

Stockton Hematology Oncology Medical Group

Recruiting

Stockton, California, United States, 95204

Stamford Hospital

Recruiting

Stamford, Connecticut, United States, 06902

MedStar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Cancer Specialists of North Florida

Recruiting

Jacksonville, Florida, United States, 32256

Jupiter Medical Center

Recruiting

Jupiter, Florida, United States, 33458

Mount Sinai Comprehensive Cancer Center

Recruiting

Miami Beach, Florida, United States, 33140

Cancer Care Centers of Brevard, Inc

Recruiting

Palm Bay, Florida, United States, 32909

Memorial Healthcare System

Recruiting

Pembroke Pines, Florida, United States, 33028

Sylvester Comprehensive Cancer Center

Recruiting

Plantation, Florida, United States, 33324

University Cancer & Blood Center, LLC.

Recruiting

Athens, Georgia, United States, 30607

Piedmont Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30318

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Northwest Georgia Oncology Centers, PC

Recruiting

Marietta, Georgia, United States, 30060

Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta

Recruiting

Newnan, Georgia, United States, 30265

Pearlman Cancer Center

Recruiting

Valdosta, Georgia, United States, 31602

Kootenai Health

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Northwestern Medicine

Recruiting

Chicago, Illinois, United States, 60611

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

NorthShore University Healthsystem

Recruiting

Evanston, Illinois, United States, 60201

Edward Hospital

Recruiting

Naperville, Illinois, United States, 60540

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Franciscan Health Indianapolis

Recruiting

Indianapolis, Indiana, United States, 46237

Mission Cancer & Blood - John Stoddard Cancer Center

Recruiting

Des Moines, Iowa, United States, 50309

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Cancer Center of Kansas

Recruiting

Wichita, Kansas, United States, 67214

Norton Healthcare, Inc.

Recruiting

Louisville, Kentucky, United States, 40207

Mercy Health

Recruiting

Paducah, Kentucky, United States, 42003

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

New England Cancer Specialists

Recruiting

Scarborough, Maine, United States, 04074

Sinai Hospital of Baltimore, Inc.

Recruiting

Baltimore, Maryland, United States, 21215

St. Agnes Hospital

Recruiting

Baltimore, Maryland, United States, 21229

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21231

James M Stockman Cancer Institute

Recruiting

Frederick, Maryland, United States, 21702

Greater Baltimore Medical Center

Recruiting

Towson, Maryland, United States, 21204

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Dana-Farber Cancer Institute @Foxborough

Recruiting

Foxborough, Massachusetts, United States, 02035

Dana-Farber Cancer Institude at Merrimack Valley

Recruiting

Methuen, Massachusetts, United States, 01844

Dana Farber Cancer Institute @ Milford Regional Hospital

Recruiting

Milford, Massachusetts, United States, 01757

Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital

Recruiting

South Weymouth, Massachusetts, United States, 02190

Cancer and Hematology Centers of Western Michigan

Recruiting

Grand Rapids, Michigan, United States, 49503

William Beaumont Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Minnesota Oncology Hematology, PA

Recruiting

Maplewood, Minnesota, United States, 55109

Virginia Piper Cancer Center (Allina Health)

Recruiting

Minneapolis, Minnesota, United States, 55407

University of Minnesota Medical Center, Fairview

Recruiting

Minneapolis, Minnesota, United States, 55455

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Metro Minnesota Community Oncology

Recruiting

Saint Louis Park, Minnesota, United States, 55426

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Baptist Clinical Research Institute

Recruiting

St Louis, Missouri, United States, 63131

Oncology Hematology West - Methodist

Recruiting

Omaha, Nebraska, United States, 68114

Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)

Recruiting

Omaha, Nebraska, United States, 68124

Regional Cancer Care Associates LLC

Recruiting

East Brunswick, New Jersey, United States, 08816

Hunterdon Medical Center

Recruiting

Flemington, New Jersey, United States, 08822

Rutgers Health

Recruiting

New Brunswick, New Jersey, United States, 08901

Overlook Medical Center

Recruiting

Summit, New Jersey, United States, 07901

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

San Juan Oncology Associates

Recruiting

Farmington, New Mexico, United States, 87401

Hematology Oncology Associates of Central New York, PC

Recruiting

East Syracuse, New York, United States, 13057

Northwell Health

Recruiting

Lake Success, New York, United States, 11042

Laura and Isaac Perlmutter Cancer Canter

Recruiting

New York, New York, United States, 10016

Lipson Cancer Institute - Linden Oaks

Recruiting

Rochester, New York, United States, 14618

New York Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

Stony Brook Medicine

Recruiting

Stony Brook, New York, United States, 11794

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

White Plains Hospital Physician Associates

Recruiting

White Plains, New York, United States, 10601

Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27514

Novant Health Cancer Institute - Elizabeth (Breast)

Recruiting

Charlotte, North Carolina, United States, 28204

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Cone Health Medical Group (Moses Cone Health System)

Recruiting

Greensboro, North Carolina, United States, 27403

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Good Samaritan Hospital

Recruiting

Cincinnati, Ohio, United States, 45220

Oncology Hematology Care, Inc.

Recruiting

Cincinnati, Ohio, United States, 45242

Ohio State University CRS

Recruiting

Columbus, Ohio, United States, 43212

Ohio Health Research Institute

Recruiting

Columbus, Ohio, United States, 43214

Columbus NCORP

Recruiting

Columbus, Ohio, United States, 43215

Anita Stewart Oncology Center

Recruiting

Columbus, Ohio, United States, 43221

St. Charles Health System, Inc. DBA St. Charles Medical Center

Recruiting

Bend, Oregon, United States, 97701

Samaritan Hospital

Recruiting

Corvallis, Oregon, United States, 97330

Willamette Valley Cancer Institute and Research Center

Recruiting

Eugene, Oregon, United States, 97401

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Lancaster General Health

Recruiting

Lancaster, Pennsylvania, United States, 17601

University of Pennsylvania Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

UPMC Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Guthrie Clinical Research

Recruiting

Sayre, Pennsylvania, United States, 18840

Lankenau Medical Center

Recruiting

Wynnewood, Pennsylvania, United States, 19106

Cancer Care Associates of York

Recruiting

York, Pennsylvania, United States, 17403

Providence Health

Recruiting

Providence, Rhode Island, United States, 02905

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Spartanburg Medical Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Monument Health Cancer Care Institute

Recruiting

Rapid City, South Dakota, United States, 57701

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

University of Tennessee

Recruiting

Knoxville, Tennessee, United States, 37920

Texas Oncology

Recruiting

Austin, Texas, United States, 78731

Texas Oncology

Recruiting

El Paso, Texas, United States, 79902

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Texas Oncology

Recruiting

San Antonio, Texas, United States, 78240

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Inova Fairfax Hospital

Recruiting

Fairfax, Virginia, United States, 22031

Bon Secours Cancer Institute at St. Francis

Recruiting

Midlothian, Virginia, United States, 23114

Oncology and Hematology Associates of Southwest Virginia, Inc

Recruiting

Wytheville, Virginia, United States, 24382

Providence Regional Cancer System

Recruiting

Lacey, Washington, United States, 98503

MultiCare Regional Cancer Center - Tacoma

Recruiting

Puyallup, Washington, United States, 98372

Northwest Medical Specialties, PLLC

Recruiting

Puyallup, Washington, United States, 98373

West Virginia University Hospital

Recruiting

Morgantown, West Virginia, United States, 26505

Ascension St. Francis Reiman Cancer Center

Recruiting

Franklin, Wisconsin, United States, 53132

More Information

Sponsor

Gilead Sciences

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

AFT-65
GBG 119
NSABP B-63
OptimICE-RD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-07-15.