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)
Recruiting · NCT05633654 · Interventional (participants receive a specific treatment) · Lead sponsor: Gilead Sciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 41 US states.
- 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
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Cedars-Sinai Cancer at Beverly Hills - Los Angeles, California, United States
- Hoag Memorial Hospital Presbyterian - Newport Beach, California, United States
- Emad Ibrahim, MD, INC - Redlands, California, United States
- Sutter Institute for Medical Research - Sacramento, California, United States
- City of Hope (Duarte) - San Francisco, California, United States
- UCSF Medical Center - San Francisco, California, United States
- Sansum Clinic - Santa Barbara, California, United States
- Stockton Hematology Oncology Medical Group - Stockton, California, United States
- University of Colorado Cancer Center - Aurora, Colorado, United States
- Norwalk Hospital - Danbury, Connecticut, United States
- Stamford Hospital - Stamford, Connecticut, United States
- MedStar Georgetown University Hospital - Washington D.C., District of Columbia, United States
- MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
- Morton Plant Hospital - Bay Care - Clearwater, Florida, United States
- University of Florida - Gainesville, Florida, United States
- Mayo Clinic Florida - Jacksonville, Florida, United States
- Cancer Specialists of North Florida - Jacksonville, Florida, United States
- Jupiter Medical Center - Jupiter, Florida, United States
- Mount Sinai Comprehensive Cancer Center - Miami Beach, Florida, United States
- Midland Florida Clinical Research Center, L - Orange City, Florida, United States
- Orlando Health - Orlando, Florida, United States
- Cancer Care Centers of Brevard, Inc - Palm Bay, Florida, United States
- Memorial Healthcare System - Pembroke Pines, Florida, United States
- Sacred Heart Medical Oncology Group - Pensacola, Florida, United States
- Sylvester Comprehensive Cancer Center - Plantation, Florida, United States
- Cleveland Clinic Florida, Martin North Hospital - Stuart, Florida, United States
- St. Joseph's Hospital - Tampa, Florida, United States
- Weston Hospital - Weston, Florida, United States
- University Cancer & Blood Center, LLC. - Athens, Georgia, United States
- Piedmont Cancer Institute - Atlanta, Georgia, United States
- Northside Hospital - Atlanta, Georgia, United States
- Northwest Georgia Oncology Centers, PC - Marietta, Georgia, United States
- Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta - Newnan, Georgia, United States
- Pearlman Cancer Center - Valdosta, Georgia, United States
- St Lukes Mountain States Tumor Institute - Boise, Idaho, United States
- Kootenai Health - Coeur d'Alene, Idaho, United States
- Northwestern Medicine - Chicago, Illinois, United States
- Rush University Medical Center - Chicago, Illinois, United States
- University of Illinois - Chicago, Illinois, United States
- University of Chicago Medical Center - Chicago, Illinois, United States
- NorthShore University Healthsystem - Evanston, Illinois, United States
- Edward Hospital - Naperville, Illinois, United States
- West Suburban Medical Center- River Forest - River Forest, Illinois, United States
- Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore - Skokie, Illinois, United States
- Springfield Clinic LLP - Springfield, Illinois, United States
- Carle Cancer Center - Urbana, Illinois, United States
- Franciscan Health Indianapolis - Indianapolis, Indiana, United States
- Investigative Clinical Research of Indiana, LLC - Indianapolis, Indiana, United States
- IU Health Arnett Hospital - Lafayette, Indiana, United States
Showing 60 of 356 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →