STATUS Recruiting

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)

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Recruiting

GILEAD STUDY ID

GS-US-595-6184

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

July 15, 2026

Clinicaltrials.gov ID

NCT05633654

CTSID

2024-512279-10

OVERVIEW

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

PROTOCOL 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.

Participation requirements

Age

18 years +

Sex

All

Healthy Volunteers

Study details

Medical Condition

Triple Negative Breast Cancer

Gender

N/A

Date

December 2022 - June 2027

Study Type

Interventional

Study Phase

Phase 3

Product

Sacituzumab govitecan-hziy (SG), Pembrolizumab, Capecitabine

Eligibility information

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.

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.

Locations

Locations (356)

Alabama Oncology

Birmingham, Alabama, United States, 35243

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)

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (356)

Alabama Oncology

Clearview Cancer Institute

Palo Verde Hematology Oncology

Mayo Clinic Hospital

Arizona Oncology Associates

Alta Bates Summit Medical Center

Community Cancer Institute

PIH Health Whittier Hospital

Compassionate Cancer Care Medical Group - Inc

Los Angeles Cancer Network

USC Norris Comprehensive Cancer Center

Cedars-Sinai Cancer at Beverly Hills

Hoag Memorial Hospital Presbyterian

Emad Ibrahim, MD, INC

Sutter Institute for Medical Research

City of Hope (Duarte)

UCSF Medical Center

Sansum Clinic

Stockton Hematology Oncology Medical Group

University of Colorado Cancer Center

Norwalk Hospital

Stamford Hospital

MedStar Georgetown University Hospital

MedStar Washington Hospital Center

Morton Plant Hospital - Bay Care

University of Florida

Mayo Clinic Florida

Cancer Specialists of North Florida

Jupiter Medical Center

Mount Sinai Comprehensive Cancer Center

Midland Florida Clinical Research Center, L

Orlando Health

Cancer Care Centers of Brevard, Inc

Memorial Healthcare System

Sacred Heart Medical Oncology Group

Sylvester Comprehensive Cancer Center

Cleveland Clinic Florida, Martin North Hospital

St. Joseph's Hospital

Weston Hospital

University Cancer & Blood Center, LLC.

Piedmont Cancer Institute

Northside Hospital

Northwest Georgia Oncology Centers, PC

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

Pearlman Cancer Center

St Lukes Mountain States Tumor Institute

Kootenai Health

Northwestern Medicine

Rush University Medical Center

University of Illinois

University of Chicago Medical Center

NorthShore University Healthsystem

Edward Hospital

West Suburban Medical Center- River Forest

Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore

Springfield Clinic LLP

Carle Cancer Center

Franciscan Health Indianapolis

Investigative Clinical Research of Indiana, LLC

IU Health Arnett Hospital

Franciscan Health Munster

Mercy Medical Center

Mission Cancer & Blood - John Stoddard Cancer Center

University of Iowa Hospitals and Clinics

Cancer Center of Kansas

University of Kentucky

Norton Healthcare, Inc.

Mercy Health