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Clinical Trials in Ireland / NCT05633654
Recruiting Phase 3

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)

NCT05633654 · tracked via the Priya Life Science Ireland tracker
Sponsor
Gilead Sciences
Phase
Phase 3
Started
2022-12-12
Last updated
2026-09-09

Condition(s) studied

Triple Negative Breast Cancer

Investigational drug(s) / intervention(s)

Sacituzumab govitecan-hziy (SG)PembrolizumabCapecitabine

Sacituzumab govitecan-hziy (SG): Administered intravenously

Pembrolizumab: Administered intravenously

Capecitabine: Tablets administered orally

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (372)

FacilityCityRegionStatus
Alabama Oncology Birmingham Alabama Recruiting
Clearview Cancer Institute Huntsville Alabama Recruiting
Palo Verde Hematology Oncology Glendale Arizona Recruiting
Mayo Clinic Hospital Phoenix Arizona Withdrawn
Arizona Oncology Associates Prescott Valley Arizona Withdrawn
Alta Bates Summit Medical Center Berkeley California Recruiting
Community Cancer Institute Clovis California Withdrawn
PIH Health Whittier Hospital Downey California Recruiting
Compassionate Cancer Care Medical Group - Inc Fountain Valley California Active Not Recruiting
Los Angeles Cancer Network Los Angeles California Active Not Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Withdrawn
Cedars-Sinai Cancer at Beverly Hills Los Angeles California Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
Emad Ibrahim, MD, INC Redlands California Withdrawn
Sutter Institute for Medical Research Sacramento California Recruiting
City of Hope (Duarte) San Francisco California Recruiting
UCSF Medical Center San Francisco California Recruiting
Sansum Clinic Santa Barbara California Recruiting
Stockton Hematology Oncology Medical Group Stockton California Recruiting
University of Colorado Cancer Center Aurora Colorado Withdrawn
Norwalk Hospital Danbury Connecticut Withdrawn
Stamford Hospital Stamford Connecticut Recruiting
MedStar Georgetown University Hospital Washington D.C. District of Columbia Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Recruiting
Morton Plant Hospital - Bay Care Clearwater Florida Withdrawn
University of Florida Gainesville Florida Withdrawn
Mayo Clinic Florida Jacksonville Florida Recruiting
Cancer Specialists of North Florida Jacksonville Florida Recruiting
Jupiter Medical Center Jupiter Florida Recruiting
Mount Sinai Comprehensive Cancer Center Miami Beach Florida Recruiting
Midland Florida Clinical Research Center, L Orange City Florida Withdrawn
Orlando Health Orlando Florida Active Not Recruiting
Cancer Care Centers of Brevard, Inc Palm Bay Florida Recruiting
Memorial Healthcare System Pembroke Pines Florida Recruiting
Sacred Heart Medical Oncology Group Pensacola Florida Withdrawn
Sylvester Comprehensive Cancer Center Plantation Florida Recruiting
Cleveland Clinic Florida, Martin North Hospital Stuart Florida Withdrawn
St. Joseph's Hospital Tampa Florida Withdrawn
Weston Hospital Weston Florida Withdrawn
University Cancer & Blood Center, LLC. Athens Georgia Recruiting

+ 332 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05633654 on ClinicalTrials.gov ↗ ← All trials in Ireland