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)
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Registration Number
- NCT05633654
- Lead Sponsor
- Gilead Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1514
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sacituzumab govitecan-hziy (SG) + Pembrolizumab Sacituzumab govitecan-hziy (SG) Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death. Sacituzumab govitecan-hziy (SG) + Pembrolizumab Pembrolizumab Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death. Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine Pembrolizumab Participants will receive one of the following TPC regimens determined prior to randomization: * Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles OR * Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles and capecitabine 1000 mg/m\^2 orally twice daily on Days 1 through 14 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death. Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine Capecitabine Participants will receive one of the following TPC regimens determined prior to randomization: * Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles OR * Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles and capecitabine 1000 mg/m\^2 orally twice daily on Days 1 through 14 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.
- Primary Outcome Measures
Name Time Method Invasive Disease-free Survival (iDFS) Up to 60 months iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to 96 months OS is defined as the time from the date of randomization until death due to any cause.
Distant Disease-free Survival (dDFS) Up to 60 months dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer.
Recurrence-free Survival (RFS) Up to 60 months RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) First dose date up to 38 months plus 30 days Percentage of Participants Experiencing Laboratory Abnormalities First dose date up to 38 months plus 30 days Time to Worsening (TTW) of Quality of Life (QoL) Based on Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) Trial Outcome Index (TOI) Scores Up to 60 months TTW of FACT-B TOI scores will be analyzed for each index, the TTW of FACT-B scores will be measured from the randomization date and to the time the participants first experienced a first score of worsening.
Trial Locations
- Locations (189)
Hunterdon Medical Center
🇺🇸Flemington, New Jersey, United States
Franciscan Health Munster
🇺🇸Munster, Indiana, 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
Pearlman Cancer Center
🇺🇸Valdosta, Georgia, United States
St Lukes Mountain States Tumor Institute
🇺🇸Boise, Idaho, 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
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
University Medical Center New Orleans
🇺🇸New Orleans, Louisiana, United States
New England Cancer Specialists
🇺🇸Scarborough, Maine, United States
Sinai Hospital of Baltimore, Inc.
🇺🇸Baltimore, Maryland, United States
Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Mission Cancer & Blood - John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
🇺🇸Fairfield, Iowa, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Norton Healthcare, Inc.
🇺🇸Louisville, Kentucky, United States
Mercy Health
🇺🇸Paducah, Kentucky, United 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
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
St. Agnes Hospital
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Medstar Franklin Square Medical Center
🇺🇸Baltimore, Maryland, United States
American Oncology Partners of Maryland, PA
🇺🇸Bethesda, Maryland, United States
James M Stockman Cancer Institute
🇺🇸Frederick, Maryland, United States
Greater Baltimore Medical Center
🇺🇸Towson, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Summit Medical Group, P.A.
🇺🇸Florham Park, New Jersey, United States
Rutgers Health
🇺🇸New Brunswick, New Jersey, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Overlook Medical Center
🇺🇸Summit, New Jersey, United States
San Juan Oncology Associates
🇺🇸Farmington, New Mexico, United States
New York Oncology Hematology (NYOH)
🇺🇸Amsterdam, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Hematology Oncology Associates of Central New York, PC
🇺🇸East Syracuse, New York, United States
Northwell Health
🇺🇸Lake Success, New York, United States
Laura and Isaac Perlmutter Cancer Canter
🇺🇸New York, New York, United States
Lipson Cancer Institute - Linden Oaks
🇺🇸Rochester, New York, United States
New York Cancer and Blood Specialists
🇺🇸Shirley, New York, United States
Stony Brook Medicine
🇺🇸Stony Brook, New York, United States
Althaia Xarxa Assistencial de Manresa
🇪🇸Manresa, Spain
Hospital Universitario Morales Meseguer
🇪🇸Murcia, Spain
HU Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain
Isabel la Catolica nº 1-3
🇪🇸Zaragoza, Spain
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
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
Morton Plant Hospital - Bay Care
🇺🇸Clearwater, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, 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
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
Baystate Medical Center Inc.
🇺🇸Springfield, Massachusetts, United States
University of Massachusetts Worcester
🇺🇸Worcester, Massachusetts, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Ascension
🇺🇸Grosse Pointe Woods, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Ascension Providence Hospital Southfield Cancer Center
🇺🇸Southfield, Michigan, United States
Trinity Health St. Joseph Mercy Ann Arbor
🇺🇸Ypsilanti, Michigan, United States
Minnesota Oncology Hematology, PA
🇺🇸Maplewood, Minnesota, United States
Virginia Piper Cancer Center (Allina Health)
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Medical Center, Fairview
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Metro Minnesota Community Oncology
🇺🇸Saint Louis Park, Minnesota, United States
Baptist Clinical Research Institute
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital
🇺🇸Saint Louis, Missouri, United States
Mary Lanning Healthcare - Morrison Cancer Center
🇺🇸Hastings, Nebraska, United States
Oncology Hematology West - Methodist
🇺🇸Omaha, Nebraska, United States
Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
🇺🇸Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Cancer Care & Hematology Specialists
🇺🇸Reno, Nevada, United States
Regional Cancer Care Associates LLC
🇺🇸East Brunswick, New Jersey, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Clinical Research Alliance
🇺🇸Westbury, New York, United States
White Plains Hospital Physician Associates
🇺🇸White Plains, New York, United States
Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Cone Health Medical Group (Moses Cone Health System)
🇺🇸Greensboro, North Carolina, United States
East Carolina University Health Medical Center
🇺🇸Greenville, North Carolina, United States
FirstHealth Outpatient Cancer Center
🇺🇸Pinehurst, North Carolina, United States
UNC Rex Cancer Center
🇺🇸Raleigh, North Carolina, United States
UNC Nash Cancer Center
🇺🇸Rocky Mount, North Carolina, United States
Atrium Health Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care, Inc.
🇺🇸Cincinnati, Ohio, United States
Ohio State University CRS
🇺🇸Columbus, Ohio, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Anita Stewart Oncology Center
🇺🇸Columbus, Ohio, United States
Toledo Clinic Cancer Center
🇺🇸Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
St. Charles Health System, Inc. DBA St. Charles Medical Center
🇺🇸Bend, Oregon, United States
Samaritan Hospital
🇺🇸Corvallis, Oregon, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
Asante Rogue Regional Medical Center
🇺🇸Medford, Oregon, United States
Providence Cancer Institute - Oncology Clinical Trials
🇺🇸Portland, Oregon, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Saint Luke's University Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Lancaster General Health
🇺🇸Lancaster, Pennsylvania, United States
University of Pennsylvania Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Guthrie Clinical Research
🇺🇸Sayre, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸West Reading, Pennsylvania, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Cancer Care Associates of York
🇺🇸York, Pennsylvania, United States
Providence Health
🇺🇸Providence, Rhode Island, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Spartanburg Medical Center
🇺🇸Spartanburg, South Carolina, United States
Monument Health Cancer Care Institute
🇺🇸Rapid City, South Dakota, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Ballad Health Cancer Care - Kingsport
🇺🇸Kingsport, Tennessee, United States
Center for Biomedical Research, LLC
🇺🇸Knoxville, Tennessee, United States
University of Tennessee
🇺🇸Knoxville, Tennessee, United States
Hendrick Health System
🇺🇸Abilene, Texas, United States
Texas Oncology
🇺🇸San Antonio, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc
🇺🇸Wytheville, Virginia, United States
Providence Regional Cancer System
🇺🇸Lacey, Washington, United States
MultiCare Regional Cancer Center - Tacoma
🇺🇸Puyallup, Washington, United States
Northwest Medical Specialties, PLLC
🇺🇸Puyallup, Washington, United States
University of Washington
🇺🇸Renton, Washington, United States
Medical Oncology Associates
🇺🇸Spokane, Washington, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
ThedaCare Regional Cancer Center
🇺🇸Appleton, Wisconsin, United States
Ascension St. Francis Reiman Cancer Center
🇺🇸Franklin, Wisconsin, United States
HSHS Saint Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Hämatologie-Onkologie im Zentrum MVZ GmbH
🇩🇪Augsburg, Germany
Studien GbR Braunschweig
🇩🇪Braunschweig, Germany
Hämato-Onkologische Praxis im Medicum
🇩🇪Bremen, Germany
St. Johannes Hospital
🇩🇪Dortmund, Germany
Klinikum Esslingen
🇩🇪Esslingen, Germany
MVZ II der Niels Stensen Kliniken
🇩🇪Georgsmarienhütte, Germany
Elisabeth Krankenhaus Brustzentrum
🇩🇪Kassel, Germany
InVO - Institut für Versorgungsforschung in der Onkologie GbR / Praxis für Hämatologie und Onkologie
🇩🇪Koblenz, Germany
St. Elisabeth Krankenhaus GmbH
🇩🇪Köln, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Klinikum Worms Frauenklinik
🇩🇪Worms, Germany
Medical Oncology Unit. A Coruña University Hospital
🇪🇸A Coruña, Spain
Hospital Universitary of Cruces
🇪🇸Barakaldo, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Consorcio Hospitalario Provincial de Castellón
🇪🇸Castellón, Spain
Hospital General Universitario De Elche
🇪🇸Elche, Spain