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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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)

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

NCT05633654•Gilead Sciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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.

Locations (288)

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

Key Dates

Start Date

December 12, 2022

Primary Completion Date

June 1, 2027

Completion Date

August 1, 2031

Last Updated

January 20, 2026

Enrollment

1,514

ESTIMATED participants

Conditions

Triple Negative Breast Cancer

Interventions

Sacituzumab govitecan-hziy (SG)

DRUG

Pembrolizumab

DRUG

Capecitabine

DRUG

Contacts

Gilead Clinical Study Information Center

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

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