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)
Trial Status: active
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.
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. 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.
Additional locations may be listed on ClinicalTrials.gov for NCT05633654.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not AvailableCalifornia
San Francisco
University of California San Francisco
Status: Active
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
District of Columbia
Washington
MedStar Washington Hospital Center
Status: Active
Name Not AvailableFlorida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not AvailableMiami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not AvailableIllinois
Chicago
Northwestern University
Status: Active
Name Not AvailableUniversity of Chicago Comprehensive Cancer Center
Status: Active
Name Not AvailableIowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not AvailableMaryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not AvailableMassachusetts
Boston
Beth Israel Deaconess Medical Center
Status: Active
Name Not AvailableBrigham and Women's Hospital
Status: Active
Name Not AvailableDana-Farber Cancer Institute
Status: Active
Name Not AvailableFoxborough
Dana-Farber Cancer Institute at Foxborough
Status: Active
Name Not AvailableMethuen
Dana Farber-Merrimack Valley
Status: Active
Name Not AvailableMilford
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Status: Active
Name Not AvailableSouth Weymouth
Dana-Farber/Brigham and Women's Cancer Center at South Shore
Status: Active
Name Not AvailableMinnesota
Minneapolis
University of Minnesota/Masonic Cancer Center
Status: Active
Name Not AvailableRochester
Mayo Clinic in Rochester
Status: Active
Name Not AvailableMissouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not AvailableNew Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not AvailableNew Mexico
Albuquerque
Lovelace Medical Center-Saint Joseph Square
Status: Active
Name Not AvailableUniversity of New Mexico Cancer Center
Status: Active
Name Not AvailablePresbyterian Kaseman Hospital
Status: Active
Name Not AvailableLas Cruces
Memorial Medical Center-Las Cruces
Status: Active
Name Not AvailableRio Rancho
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Status: Active
Name Not AvailableNew York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not AvailableBuffalo
Roswell Park Cancer Institute
Status: Active
Name Not AvailableMineola
NYU Langone Hospital - Long Island
Status: Active
Name Not AvailableNorth Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not AvailableDurham
Duke University Medical Center
Status: Active
Name Not AvailableWinston-Salem
Wake Forest University Health Sciences
Status: Active
Name Not AvailableOhio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not AvailableOklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not AvailableOregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not AvailablePennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: Approved
Name Not AvailableUniversity of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not AvailablePittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Approved
Name Not AvailableWillow Grove
Asplundh Cancer Pavilion
Status: Approved
Name Not AvailableSouth Carolina
Charleston
Medical University of South Carolina
Status: Active
Name Not AvailableTexas
Houston
M D Anderson Cancer Center
Status: Active
Name Not AvailableUtah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not AvailableVirginia
Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not AvailableWisconsin
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Status: Active
Contact: Kari Braun Wisinski
Email: kbwisinski@medicine.wisc.edu
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationGilead
- Primary IDGS-US-595-6184
- Secondary IDsNCI-2023-03800, 2024-512279-10
- ClinicalTrials.gov IDNCT05633654