RECRUITING

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)

Talk to us

Conditions

Triple Negative Breast CancerOptimICE-RDAFT-65NSABP B-63

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan 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

Quick Facts

Study Start:2022-12-12
Study Completion:2031-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05633654

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:
  2. * 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)).
  3. * Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
  4. * Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
  5. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  6. * Individuals must have received appropriate radiotherapy and have recovered prior to starting study treatment.
  7. * Adequate organ function.
  1. * Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
  2. * 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.
  3. * Evidence of recurrent disease following preoperative therapy and surgery.
  4. * Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
  5. * Individuals with germline breast cancer gene (BRCA) mutations.
  6. * 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%
  7. * Active serious infections requiring anti-microbial therapy.

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center
CONTACT
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

Alabama Oncology
Birmingham, Alabama, 35243
United States
Clearview Cancer Institute
Huntsville, Alabama, 35805
United States
Palo Verde Hematology Oncology
Glendale, Arizona, 85304
United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054
United States
Arizona Oncology Associates
Prescott Valley, Arizona, 86314
United States
Alta Bates Summit Medical Center
Berkeley, California, 94704
United States
Community Cancer Institute
Clovis, California, 93611
United States
PIH Health Whittier Hospital
Downey, California, 90241
United States
Compassionate Cancer Care Medical Group - Inc
Fountain Valley, California, 92708
United States
Los Angeles Cancer Network
Los Angeles, California, 90017
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
Emad Ibrahim, MD, INC
Redlands, California, 92373
United States
Sutter Institute for Medical Research
Sacramento, California, 95816
United States
UCSF Medical Center
San Francisco, California, 94143
United States
Sansum Clinic
Santa Barbara, California, 93105
United States
Stockton Hematology Oncology Medical Group
Stockton, California, 95204
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045
United States
Norwalk Hospital
Danbury, Connecticut, 06810
United States
Stamford Hospital
Stamford, Connecticut, 06902
United States
Morton Plant Hospital - Bay Care
Clearwater, Florida, 00337
United States
University of Florida
Gainesville, Florida, 32610
United States
Mayo Clinic Florida
Jacksonville, Florida, 32224
United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
United States
Jupiter Medical Center
Jupiter, Florida, 33458
United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
United States
Midland Florida Clinical Research Center, L
Orange City, Florida, 32763
United States
Orlando Health
Orlando, Florida, 32806
United States
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, 32909
United States
Memorial Healthcare System
Pembroke Pines, Florida, 33028
United States
Sacred Heart Medical Oncology Group
Pensacola, Florida, 32504
United States
Sylvester Comprehensive Cancer Center
Plantation, Florida, 33324
United States
Cleveland Clinic Florida, Martin North Hospital
Stuart, Florida, 34994
United States
St. Joseph's Hospital
Tampa, Florida, 33614
United States
Weston Hospital
Weston, Florida, 33331
United States
University Cancer & Blood Center, LLC.
Athens, Georgia, 30607
United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060
United States
Pearlman Cancer Center
Valdosta, Georgia, 31602
United States
St Lukes Mountain States Tumor Institute
Boise, Idaho, 83712
United States
Kootenai Health
Coeur d'Alene, Idaho, 83814
United States
Northwestern Medicine
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
University of Illinois
Chicago, Illinois, 60612
United States
NorthShore University Healthsystem
Evanston, Illinois, 60201
United States
Edward Hospital
Naperville, Illinois, 60540
United States
West Suburban Medical Center- River Forest
River Forest, Illinois, 60305
United States
Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
Skokie, Illinois, 60076
United States
Springfield Clinic LLP
Springfield, Illinois, 62702
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46260
United States
IU Health Arnett Hospital
Lafayette, Indiana, 47904
United States
Franciscan Health Munster
Munster, Indiana, 46321
United States
Mercy Medical Center
Cedar Rapids, Iowa, 52403
United States
Mission Cancer & Blood - John Stoddard Cancer Center
Des Moines, Iowa, 50309
United States
University of Iowa Hospitals and Clinics
Fairfield, Iowa, 52556
United States
Franciscan Health Indianapolis
Indianapolis, Iowa, 46237
United States
University of Kentucky
Lexington, Kentucky, 40536
United States
Norton Healthcare, Inc.
Louisville, Kentucky, 40207
United States
Mercy Health
Paducah, Kentucky, 42003
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
New England Cancer Specialists
Scarborough, Maine, 04074
United States
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland, 21215
United States
St. Agnes Hospital
Baltimore, Maryland, 21229
United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
United States
Medstar Franklin Square Medical Center
Baltimore, Maryland, 21237
United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
United States
James M Stockman Cancer Institute
Frederick, Maryland, 21702
United States
Greater Baltimore Medical Center
Towson, Maryland, 21204
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Baystate Medical Center Inc.
Springfield, Massachusetts, 01199
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
United States
Ascension
Grosse Pointe Woods, Michigan, 48236
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
Ascension Providence Hospital Southfield Cancer Center
Southfield, Michigan, 48075
United States
Trinity Health St. Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197
United States
Minnesota Oncology Hematology, PA
Maplewood, Minnesota, 55109
United States
Virginia Piper Cancer Center (Allina Health)
Minneapolis, Minnesota, 55407
United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Metro Minnesota Community Oncology
Saint Louis Park, Minnesota, 55426
United States
Baptist Clinical Research Institute
Saint Louis, Missouri, 63131
United States
Mercy Hospital
Saint Louis, Missouri, 63141
United States
Mary Lanning Healthcare - Morrison Cancer Center
Hastings, Nebraska, 68901
United States
Oncology Hematology West - Methodist
Omaha, Nebraska, 68114
United States
Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
Omaha, Nebraska, 68124
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
United States
Cancer Care & Hematology Specialists
Reno, Nevada, 89511
United States
Regional Cancer Care Associates LLC
East Brunswick, New Jersey, 08816
United States
Hunterdon Medical Center
Flemington, New Jersey, 08822
United States
Summit Medical Group, P.A.
Florham Park, New Jersey, 07932
United States
Rutgers Health
New Brunswick, New Jersey, 08901
United States
Overlook Medical Center
Summit, New Jersey, 07901
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States
San Juan Oncology Associates
Farmington, New Mexico, 87401
United States
New York Oncology Hematology (NYOH)
Amsterdam, New York, 12010
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Hematology Oncology Associates of Central New York, PC
East Syracuse, New York, 13057
United States
Northwell Health
Lake Success, New York, 11042
United States
Laura and Isaac Perlmutter Cancer Canter
New York, New York, 10016
United States
Lipson Cancer Institute - Linden Oaks
Rochester, New York, 14618
United States
New York Cancer and Blood Specialists
Shirley, New York, 11967
United States
Stony Brook Medicine
Stony Brook, New York, 11794
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Clinical Research Alliance
Westbury, New York, 11590
United States
White Plains Hospital Physician Associates
White Plains, New York, 10601
United States
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
United States
Duke Cancer Institute
Durham, North Carolina, 27710
United States
Cone Health Medical Group (Moses Cone Health System)
Greensboro, North Carolina, 27403
United States
East Carolina University Health Medical Center
Greenville, North Carolina, 27834
United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374
United States
UNC Rex Cancer Center
Raleigh, North Carolina, 27607
United States
UNC Nash Cancer Center
Rocky Mount, North Carolina, 27804
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220
United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
United States
Ohio State University CRS
Columbus, Ohio, 43212
United States
Ohio Health Research Institute
Columbus, Ohio, 43214
United States
Anita Stewart Oncology Center
Columbus, Ohio, 43221
United States
MultiCare Regional Cancer Center - Tacoma
Middletown, Ohio, 45042
United States
Toledo Clinic Cancer Center
Toledo, Ohio, 43623
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
St. Charles Health System, Inc. DBA St. Charles Medical Center
Bend, Oregon, 97701
United States
Samaritan Hospital
Corvallis, Oregon, 97330
United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
United States
Asante Rogue Regional Medical Center
Medford, Oregon, 97504
United States
Providence Cancer Institute - Oncology Clinical Trials
Portland, Oregon, 97213
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Saint Luke's University Hospital
Bethlehem, Pennsylvania, 18015
United States
Lancaster General Health
Lancaster, Pennsylvania, 17601
United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Guthrie Clinical Research
Sayre, Pennsylvania, 18840
United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611
United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19106
United States
Cancer Care Associates of York
York, Pennsylvania, 17403
United States
Providence Health
Providence, Rhode Island, 02905
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
United States
Monument Health Cancer Care Institute
Rapid City, South Dakota, 57701
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660
United States
Center for Biomedical Research, LLC
Knoxville, Tennessee, 37909
United States
University of Tennessee
Knoxville, Tennessee, 37920
United States
Hendrick Health System
Abilene, Texas, 79601
United States
Texas Oncology
Austin, Texas, 78731
United States
Texas Oncology
El Paso, Texas, 79902
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
United States
Texas Oncology
San Antonio, Texas, 78240
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
United States
Oncology and Hematology Associates of Southwest Virginia, Inc
Wytheville, Virginia, 24382
United States
Providence Regional Cancer System
Lacey, Washington, 98503
United States
Northwest Medical Specialties, PLLC
Puyallup, Washington, 98373
United States
University of Washington
Renton, Washington, 98055
United States
Medical Oncology Associates
Spokane, Washington, 99208
United States
West Virginia University Hospital
Morgantown, West Virginia, 26505
United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
United States
Ascension St. Francis Reiman Cancer Center
Franklin, Wisconsin, 53132
United States
HSHS Saint Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303
United States
University of Wisconsin
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-12
Study Completion Date2031-08

Study Record Updates

Study Start Date2022-12-12
Study Completion Date2031-08

Terms related to this study

Keywords Provided by Researchers

  • OptimICE-RD
  • AFT-65
  • NSABP B-63

Additional Relevant MeSH Terms

  • Triple Negative Breast Cancer