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
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.
Arms & interventions
- DrugSacituzumab govitecan-hziy (SG)
Administered intravenously
- DrugPembrolizumab
Administered intravenously
- DrugCapecitabine
Tablets administered orally
Outcome measures
Primary
Invasive Disease-free Survival (iDFS)
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.
Time frame: Up to 60 months
Secondary
Overall Survival (OS)
Time frame: Up to 96 months
Distant Disease-free Survival (dDFS)
Time frame: Up to 60 months
Recurrence-free Survival (RFS)
Time frame: Up to 60 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose date up to 38 months plus 30 days
Percentage of Participants Experiencing Laboratory Abnormalities
Time frame: 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
Time frame: Up to 60 months
Eligibility criteria
Study locations (184)
Alabama Oncology
Birmingham, Alabama, 35243
Clearview Cancer Institute
Huntsville, Alabama, 35805
Palo Verde Hematology Oncology
Glendale, Arizona, 85304
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Arizona Oncology Associates
Prescott Valley, Arizona, 86314
Alta Bates Summit Medical Center
Berkeley, California, 94704
Community Cancer Institute
Clovis, California, 93611
PIH Health Whittier Hospital
Downey, California, 90241
Compassionate Cancer Care Medical Group - Inc
Fountain Valley, California, 92708
Los Angeles Cancer Network
Los Angeles, California, 90017
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Cedars-Sinai Cancer at Beverly Hills
Los Angeles, California, 90048
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Emad Ibrahim, MD, INC
Redlands, California, 92373
Sutter Institute for Medical Research
Sacramento, California, 95816
City of Hope (Duarte)
San Francisco, California, 94143
UCSF Medical Center
San Francisco, California, 94143
Sansum Clinic
Santa Barbara, California, 93105
Stockton Hematology Oncology Medical Group
Stockton, California, 95204
University of Colorado Cancer Center
Aurora, Colorado, 80045
Norwalk Hospital
Danbury, Connecticut, 06810
Stamford Hospital
Stamford, Connecticut, 06902
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Morton Plant Hospital - Bay Care
Clearwater, Florida, 00337
University of Florida
Gainesville, Florida, 32610
Mayo Clinic Florida
Jacksonville, Florida, 32224
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
Jupiter Medical Center
Jupiter, Florida, 33458
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Midland Florida Clinical Research Center, L
Orange City, Florida, 32763
Orlando Health
Orlando, Florida, 32806
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, 32909
Memorial Healthcare System
Pembroke Pines, Florida, 33028
Sacred Heart Medical Oncology Group
Pensacola, Florida, 32504
Sylvester Comprehensive Cancer Center
Plantation, Florida, 33324
Cleveland Clinic Florida, Martin North Hospital
Stuart, Florida, 34994
St. Joseph's Hospital
Tampa, Florida, 33614
Weston Hospital
Weston, Florida, 33331
University Cancer & Blood Center, LLC.
Athens, Georgia, 30607
Piedmont Cancer Institute
Atlanta, Georgia, 30318
Northside Hospital
Atlanta, Georgia, 30342
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060
Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
Newnan, Georgia, 30265
Pearlman Cancer Center
Valdosta, Georgia, 31602
St Lukes Mountain States Tumor Institute
Boise, Idaho, 83712
Kootenai Health
Coeur d'Alene, Idaho, 83814
Northwestern Medicine
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
NorthShore University Healthsystem
Evanston, Illinois, 60201
Edward Hospital
Naperville, Illinois, 60540
West Suburban Medical Center- River Forest
River Forest, Illinois, 60305
Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
Skokie, Illinois, 60076
Springfield Clinic LLP
Springfield, Illinois, 62702
Carle Cancer Center
Urbana, Illinois, 61801
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46260
IU Health Arnett Hospital
Lafayette, Indiana, 47904
Franciscan Health Munster
Munster, Indiana, 46321
Mercy Medical Center
Cedar Rapids, Iowa, 52403
Mission Cancer & Blood - John Stoddard Cancer Center
Des Moines, Iowa, 50309
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Cancer Center of Kansas
Wichita, Kansas, 67214
University of Kentucky
Lexington, Kentucky, 40536
Norton Healthcare, Inc.
Louisville, Kentucky, 40207
Mercy Health
Paducah, Kentucky, 42003
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
University Medical Center New Orleans
New Orleans, Louisiana, 70112
New England Cancer Specialists
Scarborough, Maine, 04074
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland, 21215
St. Agnes Hospital
Baltimore, Maryland, 21229
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
James M Stockman Cancer Institute
Frederick, Maryland, 21702
Greater Baltimore Medical Center
Towson, Maryland, 21204
Massachusetts General Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute @Foxborough
Foxborough, Massachusetts, 02035
Dana-Farber Cancer Institude at Merrimack Valley
Methuen, Massachusetts, 01844
Dana Farber Cancer Institute @ Milford Regional Hospital
Milford, Massachusetts, 01757
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
South Weymouth, Massachusetts, 02190
Baystate Medical Center Inc.
Springfield, Massachusetts, 01199
University of Massachusetts Worcester
Worcester, Massachusetts, 01655
Henry Ford Health System
Detroit, Michigan, 48202
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
Ascension
Grosse Pointe Woods, Michigan, 48236
William Beaumont Hospital
Royal Oak, Michigan, 48073
Ascension Providence Hospital Southfield Cancer Center
Southfield, Michigan, 48075
Trinity Health St. Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197
Minnesota Oncology Hematology, PA
Maplewood, Minnesota, 55109
Virginia Piper Cancer Center (Allina Health)
Minneapolis, Minnesota, 55407
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Metro Minnesota Community Oncology
Saint Louis Park, Minnesota, 55426
Washington University School of Medicine
St Louis, Missouri, 63110
Baptist Clinical Research Institute
St Louis, Missouri, 63131
Mercy Hospital
St Louis, Missouri, 63141
Mary Lanning Healthcare - Morrison Cancer Center
Hastings, Nebraska, 68901
Oncology Hematology West - Methodist
Omaha, Nebraska, 68114
Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
Omaha, Nebraska, 68124
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Cancer Care & Hematology Specialists
Reno, Nevada, 89511
Regional Cancer Care Associates LLC
East Brunswick, New Jersey, 08816
Hunterdon Medical Center
Flemington, New Jersey, 08822
Summit Medical Group, P.A.
Florham Park, New Jersey, 07932
Rutgers Health
New Brunswick, New Jersey, 08901
Overlook Medical Center
Summit, New Jersey, 07901
University of New Mexico
Albuquerque, New Mexico, 87131
San Juan Oncology Associates
Farmington, New Mexico, 87401
New York Oncology Hematology (NYOH)
Amsterdam, New York, 12010
Roswell Park Cancer Institute
Buffalo, New York, 14263
Hematology Oncology Associates of Central New York, PC
East Syracuse, New York, 13057
Northwell Health
Lake Success, New York, 11042
Laura and Isaac Perlmutter Cancer Canter
New York, New York, 10016
Lipson Cancer Institute - Linden Oaks
Rochester, New York, 14618
New York Cancer and Blood Specialists
Shirley, New York, 11967
Stony Brook Medicine
Stony Brook, New York, 11794
SUNY Upstate Medical University
Syracuse, New York, 13210
Montefiore Medical Center
The Bronx, New York, 10467
Clinical Research Alliance
Westbury, New York, 11590
White Plains Hospital Physician Associates
White Plains, New York, 10601
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
Duke Cancer Institute
Durham, North Carolina, 27710
Cone Health Medical Group (Moses Cone Health System)
Greensboro, North Carolina, 27403
East Carolina University Health Medical Center
Greenville, North Carolina, 27834
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374
UNC Rex Cancer Center
Raleigh, North Carolina, 27607
UNC Nash Cancer Center
Rocky Mount, North Carolina, 27804
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
Ohio State University CRS
Columbus, Ohio, 43212
Ohio Health Research Institute
Columbus, Ohio, 43214
Columbus NCORP
Columbus, Ohio, 43215
Anita Stewart Oncology Center
Columbus, Ohio, 43221
Toledo Clinic Cancer Center
Toledo, Ohio, 43623
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
St. Charles Health System, Inc. DBA St. Charles Medical Center
Bend, Oregon, 97701
Samaritan Hospital
Corvallis, Oregon, 97330
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
Asante Rogue Regional Medical Center
Medford, Oregon, 97504
Providence Cancer Institute - Oncology Clinical Trials
Portland, Oregon, 97213
Oregon Health & Science University
Portland, Oregon, 97239
Saint Luke's University Hospital
Bethlehem, Pennsylvania, 18015
Lancaster General Health
Lancaster, Pennsylvania, 17601
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Guthrie Clinical Research
Sayre, Pennsylvania, 18840
Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611
Lankenau Medical Center
Wynnewood, Pennsylvania, 19106
Cancer Care Associates of York
York, Pennsylvania, 17403
Providence Health
Providence, Rhode Island, 02905
Medical University of South Carolina
Charleston, South Carolina, 29425
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Monument Health Cancer Care Institute
Rapid City, South Dakota, 57701
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660
Center for Biomedical Research, LLC
Knoxville, Tennessee, 37909
University of Tennessee
Knoxville, Tennessee, 37920
Hendrick Health System
Abilene, Texas, 79601
Texas Oncology
Austin, Texas, 78731
Texas Oncology
El Paso, Texas, 79902
MD Anderson Cancer Center
Houston, Texas, 77030
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
Texas Oncology
San Antonio, Texas, 78240
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of Virginia
Charlottesville, Virginia, 22908
Inova Fairfax Hospital
Fairfax, Virginia, 22031
Bon Secours Cancer Institute at St. Francis
Midlothian, Virginia, 23114
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
Oncology and Hematology Associates of Southwest Virginia, Inc
Wytheville, Virginia, 24382
Providence Regional Cancer System
Lacey, Washington, 98503
MultiCare Regional Cancer Center - Tacoma
Puyallup, Washington, 98372
Northwest Medical Specialties, PLLC
Puyallup, Washington, 98373
University of Washington
Renton, Washington, 98055
Medical Oncology Associates
Spokane, Washington, 99208
West Virginia University Hospital
Morgantown, West Virginia, 26505
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Ascension St. Francis Reiman Cancer Center
Franklin, Wisconsin, 53132
HSHS Saint Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303
University of Wisconsin
Madison, Wisconsin, 53792
References
- Tolaney SM, DeMichele A, Takano T, Rugo HS, Perou C, Lynce F, Parsons HA, Santa-Maria CA, Rocque GB, Yao W, Sun SW, Mocci S, Partridge AH, Carey LA. OptimICE-RD: sacituzumab govitecan + pembrolizumab vs pembrolizumab (+/- capecitabine) for residual triple-negative breast cancer. Future Oncol. 2024;20(31):2343-2355. doi: 10.1080/14796694.2024.2357534. Epub 2024 Jun 26.(PubMed)