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/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 or concurrent treatment with any endocrine therapy agent.
- 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 (165)
Alabama Oncology
๐บ๐ธBirmingham, Alabama, United States
Clearview Cancer Institute
๐บ๐ธHuntsville, Alabama, United States
Northwestern Medicine
๐บ๐ธChicago, Illinois, United States
Palo Verde Hematology Oncology
๐บ๐ธGlendale, Arizona, United States
Mayo Clinic Hospital
๐บ๐ธPhoenix, Arizona, United States
PIH Health Whittier Hospital
๐บ๐ธDowney, California, United States
Compassionate Cancer Care Medical Group - Inc
๐บ๐ธFountain Valley, California, United States
Los Angeles Cancer Network
๐บ๐ธLos Angeles, California, United States
Arizona Oncology Associates
๐บ๐ธPrescott Valley, Arizona, United States
Alta Bates Summit Medical Center
๐บ๐ธBerkeley, California, United States
Community Cancer Institute
๐บ๐ธClovis, California, United States
USC Norris Comprehensive Cancer Center
๐บ๐ธLos Angeles, California, United States
Hoag Memorial Hospital Presbyterian
๐บ๐ธNewport Beach, California, United States
Emad Ibrahim, MD, INC
๐บ๐ธRedlands, California, United States
Sutter Institute for Medical Research
๐บ๐ธSacramento, California, United States
UCSF Medical Center
๐บ๐ธSan Francisco, California, United States
Sansum Clinic
๐บ๐ธSanta Barbara, California, United States
Stockton Hematology Oncology Medical Group
๐บ๐ธStockton, California, United States
University of Colorado Cancer Center
๐บ๐ธAurora, Colorado, United States
Norwalk Hospital
๐บ๐ธDanbury, Connecticut, United States
Stamford Hospital
๐บ๐ธStamford, Connecticut, United States
Morton Plant Hospital - Bay Care
๐บ๐ธClearwater, Florida, United States
University of Florida
๐บ๐ธGainesville, Florida, United States
Mayo Clinic Florida
๐บ๐ธJacksonville, Florida, United States
Cancer Specialists of North Florida
๐บ๐ธJacksonville, Florida, United States
Jupiter Medical Center
๐บ๐ธJupiter, Florida, United States
Mount Sinai Comprehensive Cancer Center
๐บ๐ธMiami Beach, Florida, United States
Midland Florida Clinical Research Center, L
๐บ๐ธOrange City, Florida, United States
Orlando Health
๐บ๐ธOrlando, Florida, United States
Cancer Care Centers of Brevard, Inc
๐บ๐ธPalm Bay, Florida, United States
Memorial Healthcare System
๐บ๐ธPembroke Pines, Florida, United States
Sacred Heart Medical Oncology Group
๐บ๐ธPensacola, Florida, United States
Sylvester Comprehensive Cancer Center
๐บ๐ธPlantation, Florida, United States
Cleveland Clinic Florida, Martin North Hospital
๐บ๐ธStuart, Florida, United States
St. Joseph's Hospital
๐บ๐ธTampa, Florida, United States
Weston Hospital
๐บ๐ธWeston, Florida, United States
University Cancer & Blood Center, LLC.
๐บ๐ธAthens, Georgia, United States
Piedmont Cancer Institute
๐บ๐ธAtlanta, Georgia, United States
Northside Hospital
๐บ๐ธAtlanta, Georgia, United States
Northwest Georgia Oncology Centers, PC
๐บ๐ธMarietta, Georgia, United States
Pearlman Cancer Center
๐บ๐ธValdosta, Georgia, United States
St Lukes Mountain States Tumor Institute
๐บ๐ธBoise, Idaho, United States
Kootenai Health
๐บ๐ธCoeur d'Alene, Idaho, United States
Rush University Medical Center
๐บ๐ธChicago, Illinois, United States
University of Illinois
๐บ๐ธChicago, Illinois, United States
NorthShore University Healthsystem
๐บ๐ธEvanston, Illinois, United States
Edward Hospital
๐บ๐ธNaperville, Illinois, United States
West Suburban Medical Center- River Forest
๐บ๐ธRiver Forest, Illinois, United States
Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
๐บ๐ธSkokie, Illinois, United States
Springfield Clinic LLP
๐บ๐ธSpringfield, Illinois, United States
Carle Cancer Center
๐บ๐ธUrbana, Illinois, United States
IU Health Arnett Hospital
๐บ๐ธLafayette, Indiana, United States
Investigative Clinical Research of Indiana, LLC
๐บ๐ธIndianapolis, Indiana, United States
Franciscan Health Munster
๐บ๐ธMunster, Indiana, United States
Mission Cancer & Blood - John Stoddard Cancer Center
๐บ๐ธDes Moines, Iowa, United States
University of Iowa Hospitals and Clinics
๐บ๐ธFairfield, Iowa, United States
Franciscan Health Indianapolis
๐บ๐ธIndianapolis, Iowa, United States
University of Kentucky
๐บ๐ธLexington, Kentucky, United States
Mercy Medical Center
๐บ๐ธCedar Rapids, Iowa, United States
Norton Healthcare, Inc.
๐บ๐ธLouisville, Kentucky, United States
Mercy Health
๐บ๐ธPaducah, Kentucky, United States
Mary Bird Perkins Cancer Center
๐บ๐ธBaton Rouge, Louisiana, United States
University Medical Center New Orleans
๐บ๐ธNew Orleans, Louisiana, United States
New England Cancer Specialists
๐บ๐ธScarborough, Maine, United States
Sinai Hospital of Baltimore, Inc.
๐บ๐ธBaltimore, Maryland, United States
St. Agnes Hospital
๐บ๐ธBaltimore, Maryland, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
๐บ๐ธBaltimore, Maryland, United States
Medstar Franklin Square Medical Center
๐บ๐ธBaltimore, Maryland, United States
American Oncology Partners of Maryland, PA
๐บ๐ธBethesda, Maryland, United States
James M Stockman Cancer Institute
๐บ๐ธFrederick, Maryland, United States
Dana Farber Cancer Institute
๐บ๐ธBoston, Massachusetts, United States
Greater Baltimore Medical Center
๐บ๐ธTowson, Maryland, United States
Baystate Medical Center Inc.
๐บ๐ธSpringfield, Massachusetts, United States
Tufts Medical Center
๐บ๐ธBoston, Massachusetts, United States
Beth Israel Deaconess Medical Center
๐บ๐ธBoston, Massachusetts, United States
Henry Ford Health System
๐บ๐ธDetroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan
๐บ๐ธGrand Rapids, Michigan, United States
Ascension
๐บ๐ธGrosse Pointe Woods, Michigan, United States
William Beaumont Hospital
๐บ๐ธRoyal Oak, Michigan, United States
Ascension Providence Hospital Southfield Cancer Center
๐บ๐ธSouthfield, Michigan, United States
Trinity Health St. Joseph Mercy Ann Arbor
๐บ๐ธYpsilanti, Michigan, United States
Minnesota Oncology Hematology, PA
๐บ๐ธMaplewood, Minnesota, United States
Virginia Piper Cancer Center (Allina Health)
๐บ๐ธMinneapolis, Minnesota, United States
University of Minnesota Medical Center, Fairview
๐บ๐ธMinneapolis, Minnesota, United States
Mayo Clinic Rochester
๐บ๐ธRochester, Minnesota, United States
Metro Minnesota Community Oncology
๐บ๐ธSaint Louis Park, Minnesota, United States
Baptist Clinical Research Institute
๐บ๐ธSaint Louis, Missouri, United States
Mercy Hospital
๐บ๐ธSaint Louis, Missouri, United States
Mary Lanning Healthcare - Morrison Cancer Center
๐บ๐ธHastings, Nebraska, United States
Oncology Hematology West - Methodist
๐บ๐ธOmaha, Nebraska, United States
Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
๐บ๐ธOmaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
๐บ๐ธLas Vegas, Nevada, United States
Cancer Care & Hematology Specialists
๐บ๐ธReno, Nevada, United States
Regional Cancer Care Associates LLC
๐บ๐ธEast Brunswick, New Jersey, United States
Hunterdon Medical Center
๐บ๐ธFlemington, New Jersey, United States
Summit Medical Group, P.A.
๐บ๐ธFlorham Park, New Jersey, United States
Rutgers Health
๐บ๐ธNew Brunswick, New Jersey, United States
Overlook Medical Center
๐บ๐ธSummit, New Jersey, United States
University of New Mexico
๐บ๐ธAlbuquerque, New Mexico, United States
San Juan Oncology Associates
๐บ๐ธFarmington, New Mexico, United States
New York Oncology Hematology (NYOH)
๐บ๐ธAmsterdam, New York, United States
Montefiore Medical Center
๐บ๐ธBronx, New York, United States
Hematology Oncology Associates of Central New York, PC
๐บ๐ธEast Syracuse, New York, United States
Northwell Health
๐บ๐ธLake Success, New York, United States
Laura and Isaac Perlmutter Cancer Canter
๐บ๐ธNew York, New York, United States
Lipson Cancer Institute - Linden Oaks
๐บ๐ธRochester, New York, United States
New York Cancer and Blood Specialists
๐บ๐ธShirley, New York, United States
Stony Brook Medicine
๐บ๐ธStony Brook, New York, United States
SUNY Upstate Medical University
๐บ๐ธSyracuse, New York, United States
Clinical Research Alliance
๐บ๐ธWestbury, New York, United States
Cone Health Medical Group (Moses Cone Health System)
๐บ๐ธGreensboro, North Carolina, United States
East Carolina University Health Medical Center
๐บ๐ธGreenville, North Carolina, United States
White Plains Hospital Physician Associates
๐บ๐ธWhite Plains, New York, United States
Lineberger Comprehensive Cancer Center
๐บ๐ธChapel Hill, North Carolina, United States
Duke Cancer Institute
๐บ๐ธDurham, North Carolina, United States
FirstHealth Outpatient Cancer Center
๐บ๐ธPinehurst, North Carolina, United States
UNC Rex Cancer Center
๐บ๐ธRaleigh, North Carolina, United States
UNC Nash Cancer Center
๐บ๐ธRocky Mount, North Carolina, United States
Atrium Health Wake Forest Baptist
๐บ๐ธWinston-Salem, North Carolina, United States
Good Samaritan Hospital
๐บ๐ธCincinnati, Ohio, United States
Oncology Hematology Care, Inc.
๐บ๐ธCincinnati, Ohio, United States
Ohio State University CRS
๐บ๐ธColumbus, Ohio, United States
Anita Stewart Oncology Center
๐บ๐ธColumbus, Ohio, United States
MultiCare Regional Cancer Center - Tacoma
๐บ๐ธMiddletown, Ohio, United States
Ohio Health Research Institute
๐บ๐ธColumbus, Ohio, United States
Toledo Clinic Cancer Center
๐บ๐ธToledo, Ohio, United States
University of Oklahoma Health Sciences Center
๐บ๐ธOklahoma City, Oklahoma, United States
St. Charles Health System, Inc. DBA St. Charles Medical Center
๐บ๐ธBend, Oregon, United States
Samaritan Hospital
๐บ๐ธCorvallis, Oregon, United States
Willamette Valley Cancer Institute and Research Center
๐บ๐ธEugene, Oregon, United States
Asante Rogue Regional Medical Center
๐บ๐ธMedford, Oregon, United States
Providence Cancer Institute - Oncology Clinical Trials
๐บ๐ธPortland, Oregon, United States
Oregon Health & Science University
๐บ๐ธPortland, Oregon, United States
Saint Luke's University Hospital
๐บ๐ธBethlehem, Pennsylvania, United States
Lancaster General Health
๐บ๐ธLancaster, Pennsylvania, United States
University of Pennsylvania Abramson Cancer Center
๐บ๐ธPhiladelphia, Pennsylvania, United States
Guthrie Clinical Research
๐บ๐ธSayre, Pennsylvania, United States
Reading Hospital and Medical Center
๐บ๐ธWest Reading, Pennsylvania, United States
Lankenau Medical Center
๐บ๐ธWynnewood, Pennsylvania, United States
Cancer Care Associates of York
๐บ๐ธYork, Pennsylvania, United States
Providence Health
๐บ๐ธProvidence, Rhode Island, United States
Medical University of South Carolina
๐บ๐ธCharleston, South Carolina, United States
Spartanburg Medical Center
๐บ๐ธSpartanburg, South Carolina, United States
Avera Cancer Institute
๐บ๐ธSioux Falls, South Dakota, United States
Monument Health Cancer Care Institute
๐บ๐ธRapid City, South Dakota, United States
Ballad Health Cancer Care - Kingsport
๐บ๐ธKingsport, Tennessee, United States
Center for Biomedical Research, LLC
๐บ๐ธKnoxville, Tennessee, United States
University of Tennessee
๐บ๐ธKnoxville, Tennessee, United States
Hendrick Health System
๐บ๐ธAbilene, Texas, United States
Texas Oncology
๐บ๐ธSan Antonio, Texas, United States
MD Anderson Cancer Center
๐บ๐ธHouston, Texas, United States
Joe Arrington Cancer Research and Treatment Center
๐บ๐ธLubbock, Texas, United States
University of Virginia
๐บ๐ธCharlottesville, Virginia, United States
Virginia Commonwealth University Medical Center
๐บ๐ธRichmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc
๐บ๐ธWytheville, Virginia, United States
Providence Regional Cancer System
๐บ๐ธLacey, Washington, United States
Huntsman Cancer Institute
๐บ๐ธSalt Lake City, Utah, United States
Northwest Medical Specialties, PLLC
๐บ๐ธPuyallup, Washington, United States
University of Washington
๐บ๐ธRenton, Washington, United States
Medical Oncology Associates
๐บ๐ธSpokane, Washington, United States
West Virginia University Hospital
๐บ๐ธMorgantown, West Virginia, United States
ThedaCare Regional Cancer Center
๐บ๐ธAppleton, Wisconsin, United States
Ascension St. Francis Reiman Cancer Center
๐บ๐ธFranklin, Wisconsin, United States
HSHS Saint Mary's Hospital Medical Center - Green Bay
๐บ๐ธGreen Bay, Wisconsin, United States
University of Wisconsin
๐บ๐ธMadison, Wisconsin, United States
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