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
Status: Recruiting
Location: See all (225) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Alabama Oncology
RECRUITING
Birmingham
Clearview Cancer Institute
RECRUITING
Huntsville
Arizona
Palo Verde Hematology Oncology
RECRUITING
Glendale
Mayo Clinic Hospital
RECRUITING
Phoenix
Arizona Oncology Associates
WITHDRAWN
Prescott Valley
California
Alta Bates Summit Medical Center
RECRUITING
Berkeley
Community Cancer Institute
WITHDRAWN
Clovis
PIH Health Whittier Hospital
RECRUITING
Downey
Compassionate Cancer Care Medical Group - Inc
RECRUITING
Fountain Valley
Cedars-Sinai Cancer at Beverly Hills
RECRUITING
Los Angeles
Los Angeles Cancer Network
RECRUITING
Los Angeles
USC Norris Comprehensive Cancer Center
WITHDRAWN
Los Angeles
Hoag Memorial Hospital Presbyterian
RECRUITING
Newport Beach
Emad Ibrahim, MD, INC
WITHDRAWN
Redlands
Sutter Institute for Medical Research
RECRUITING
Sacramento
UCSF Medical Center
RECRUITING
San Francisco
Sansum Clinic
RECRUITING
Santa Barbara
Stockton Hematology Oncology Medical Group
RECRUITING
Stockton
Colorado
University of Colorado Cancer Center
WITHDRAWN
Aurora
Connecticut
Norwalk Hospital
WITHDRAWN
Danbury
Stamford Hospital
WITHDRAWN
Stamford
Florida
Morton Plant Hospital - Bay Care
WITHDRAWN
Clearwater
University of Florida
WITHDRAWN
Gainesville
Cancer Specialists of North Florida
RECRUITING
Jacksonville
Mayo Clinic Florida
RECRUITING
Jacksonville
Jupiter Medical Center
RECRUITING
Jupiter
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Midland Florida Clinical Research Center, L
WITHDRAWN
Orange City
Orlando Health
RECRUITING
Orlando
Cancer Care Centers of Brevard, Inc
WITHDRAWN
Palm Bay
Memorial Healthcare System
RECRUITING
Pembroke Pines
Sacred Heart Medical Oncology Group
WITHDRAWN
Pensacola
Sylvester Comprehensive Cancer Center
RECRUITING
Plantation
Cleveland Clinic Florida, Martin North Hospital
WITHDRAWN
Stuart
St. Joseph's Hospital
WITHDRAWN
Tampa
Weston Hospital
WITHDRAWN
Weston
Georgia
University Cancer & Blood Center, LLC.
RECRUITING
Athens
Northside Hospital
RECRUITING
Atlanta
Piedmont Cancer Institute
RECRUITING
Atlanta
Northwest Georgia Oncology Centers, PC
RECRUITING
Marietta
Pearlman Cancer Center
RECRUITING
Valdosta
Iowa
Mercy Medical Center
RECRUITING
Cedar Rapids
Mission Cancer & Blood - John Stoddard Cancer Center
RECRUITING
Des Moines
University of Iowa Hospitals and Clinics
RECRUITING
Fairfield
Idaho
St Lukes Mountain States Tumor Institute
WITHDRAWN
Boise
Kootenai Health
RECRUITING
Coeur D'alene
Illinois
Northwestern Medicine
RECRUITING
Chicago
Rush University Medical Center
RECRUITING
Chicago
University of Chicago Medical Center
RECRUITING
Chicago
University of Illinois
WITHDRAWN
Chicago
NorthShore University Healthsystem
RECRUITING
Evanston
Edward Hospital
RECRUITING
Naperville
West Suburban Medical Center- River Forest
WITHDRAWN
River Forest
Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
WITHDRAWN
Skokie
Springfield Clinic LLP
WITHDRAWN
Springfield
Carle Cancer Center
RECRUITING
Urbana
Indiana
Franciscan Health Indianapolis
RECRUITING
Indianapolis
Investigative Clinical Research of Indiana, LLC
WITHDRAWN
Indianapolis
IU Health Arnett Hospital
WITHDRAWN
Lafayette
Franciscan Health Munster
WITHDRAWN
Munster
Kentucky
University of Kentucky
WITHDRAWN
Lexington
Norton Healthcare, Inc.
RECRUITING
Louisville
Mercy Health
RECRUITING
Paducah
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
University Medical Center New Orleans
WITHDRAWN
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Baystate Medical Center Inc.
WITHDRAWN
Springfield
University of Massachusetts Worcester
RECRUITING
Worcester
Maryland
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
RECRUITING
Baltimore
Medstar Franklin Square Medical Center
RECRUITING
Baltimore
Sinai Hospital of Baltimore, Inc.
RECRUITING
Baltimore
St. Agnes Hospital
RECRUITING
Baltimore
American Oncology Partners of Maryland, PA
WITHDRAWN
Bethesda
James M Stockman Cancer Institute
RECRUITING
Frederick
Greater Baltimore Medical Center
RECRUITING
Towson
Maine
New England Cancer Specialists
RECRUITING
Scarborough
Michigan
Henry Ford Health System
RECRUITING
Detroit
Cancer and Hematology Centers of Western Michigan
RECRUITING
Grand Rapids
Ascension
WITHDRAWN
Grosse Pointe Woods
William Beaumont Hospital
RECRUITING
Royal Oak
Ascension Providence Hospital Southfield Cancer Center
RECRUITING
Southfield
Trinity Health St. Joseph Mercy Ann Arbor
WITHDRAWN
Ypsilanti
Minnesota
Minnesota Oncology Hematology, PA
RECRUITING
Maplewood
University of Minnesota Medical Center, Fairview
RECRUITING
Minneapolis
Virginia Piper Cancer Center (Allina Health)
RECRUITING
Minneapolis
Mayo Clinic Rochester
RECRUITING
Rochester
Metro Minnesota Community Oncology
RECRUITING
Saint Louis Park
Missouri
Baptist Clinical Research Institute
RECRUITING
St Louis
Mercy Hospital
WITHDRAWN
St Louis
North Carolina
Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
Duke Cancer Institute
RECRUITING
Durham
Cone Health Medical Group (Moses Cone Health System)
RECRUITING
Greensboro
East Carolina University Health Medical Center
RECRUITING
Greenville
FirstHealth Outpatient Cancer Center
WITHDRAWN
Pinehurst
UNC Rex Cancer Center
RECRUITING
Raleigh
UNC Nash Cancer Center
WITHDRAWN
Rocky Mount
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
Nebraska
Mary Lanning Healthcare - Morrison Cancer Center
RECRUITING
Hastings
Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
RECRUITING
Omaha
Oncology Hematology West - Methodist
RECRUITING
Omaha
New Jersey
Regional Cancer Care Associates LLC
RECRUITING
East Brunswick
Hunterdon Medical Center
RECRUITING
Flemington
Summit Medical Group, P.A.
WITHDRAWN
Florham Park
Rutgers Health
RECRUITING
New Brunswick
Overlook Medical Center
RECRUITING
Summit
New Mexico
University of New Mexico
RECRUITING
Albuquerque
San Juan Oncology Associates
RECRUITING
Farmington
Nevada
Comprehensive Cancer Centers of Nevada
WITHDRAWN
Las Vegas
Cancer Care & Hematology Specialists
WITHDRAWN
Reno
New York
New York Oncology Hematology (NYOH)
WITHDRAWN
Amsterdam
Roswell Park Cancer Institute
RECRUITING
Buffalo
Hematology Oncology Associates of Central New York, PC
RECRUITING
East Syracuse
Northwell Health
WITHDRAWN
Lake Success
Laura and Isaac Perlmutter Cancer Canter
RECRUITING
New York
Lipson Cancer Institute - Linden Oaks
RECRUITING
Rochester
New York Cancer and Blood Specialists
RECRUITING
Shirley
Stony Brook Medicine
RECRUITING
Stony Brook
SUNY Upstate Medical University
RECRUITING
Syracuse
Montefiore Medical Center
WITHDRAWN
The Bronx
Clinical Research Alliance
WITHDRAWN
Westbury
White Plains Hospital Physician Associates
RECRUITING
White Plains
Ohio
Good Samaritan Hospital
RECRUITING
Cincinnati
Oncology Hematology Care, Inc.
RECRUITING
Cincinnati
Anita Stewart Oncology Center
RECRUITING
Columbus
Ohio Health Research Institute
RECRUITING
Columbus
Ohio State University CRS
RECRUITING
Columbus
Toledo Clinic Cancer Center
NOT_YET_RECRUITING
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
WITHDRAWN
Oklahoma City
Oregon
St. Charles Health System, Inc. DBA St. Charles Medical Center
RECRUITING
Bend
Samaritan Hospital
RECRUITING
Corvallis
Willamette Valley Cancer Institute and Research Center
RECRUITING
Eugene
Asante Rogue Regional Medical Center
WITHDRAWN
Medford
Oregon Health & Science University
RECRUITING
Portland
Providence Cancer Institute - Oncology Clinical Trials
WITHDRAWN
Portland
Pennsylvania
Saint Luke's University Hospital
WITHDRAWN
Bethlehem
Lancaster General Health
RECRUITING
Lancaster
University of Pennsylvania Abramson Cancer Center
RECRUITING
Philadelphia
Guthrie Clinical Research
RECRUITING
Sayre
Reading Hospital and Medical Center
WITHDRAWN
West Reading
Lankenau Medical Center
RECRUITING
Wynnewood
Cancer Care Associates of York
RECRUITING
York
Rhode Island
Providence Health
RECRUITING
Providence
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Spartanburg Medical Center
RECRUITING
Spartanburg
South Dakota
Monument Health Cancer Care Institute
RECRUITING
Rapid City
Avera Cancer Institute
RECRUITING
Sioux Falls
Tennessee
Ballad Health Cancer Care - Kingsport
WITHDRAWN
Kingsport
Center for Biomedical Research, LLC
WITHDRAWN
Knoxville
University of Tennessee
RECRUITING
Knoxville
Texas
Hendrick Health System
WITHDRAWN
Abilene
Texas Oncology
RECRUITING
Austin
Texas Oncology
RECRUITING
El Paso
MD Anderson Cancer Center
RECRUITING
Houston
Joe Arrington Cancer Research and Treatment Center
RECRUITING
Lubbock
Texas Oncology
RECRUITING
San Antonio
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
University of Virginia
RECRUITING
Charlottesville
Inova Fairfax Hospital
RECRUITING
Fairfax
Virginia Commonwealth University Medical Center
WITHDRAWN
Richmond
Oncology and Hematology Associates of Southwest Virginia, Inc
RECRUITING
Wytheville
Washington
Providence Regional Cancer System
RECRUITING
Lacey
MultiCare Regional Cancer Center - Tacoma
RECRUITING
Puyallup
Northwest Medical Specialties, PLLC
RECRUITING
Puyallup
University of Washington
WITHDRAWN
Renton
Medical Oncology Associates
WITHDRAWN
Spokane
Wisconsin
ThedaCare Regional Cancer Center
WITHDRAWN
Appleton
Ascension St. Francis Reiman Cancer Center
RECRUITING
Franklin
HSHS Saint Mary's Hospital Medical Center - Green Bay
RECRUITING
Green Bay
University of Wisconsin
WITHDRAWN
Madison
West Virginia
West Virginia University Hospital
RECRUITING
Morgantown
Other Locations
Australia
Macarthur Cancer Therapy Centre, Campbelltown Hospital
NOT_YET_RECRUITING
Campbelltown
Monash Medical Centre
RECRUITING
Clayton
Lake Macquarie Private Hospital
RECRUITING
Gateshead
Princess Alexandra Hospital
RECRUITING
Woolloongabba
France
Pôle Santé Léonard De Vinci - ROC37
RECRUITING
Chambray-lès-tours
Clinique Victor Hugo
RECRUITING
Le Mans
Hôpital Privé Jean Mermoz
RECRUITING
Lyon
Hopital Privé des Côtes d'Armor - Centre CARIO-HPCA
RECRUITING
Plérin
Centre Eugène Marquis
RECRUITING
Rennes
Oncopole Claudius Regaud - IUCT-O
RECRUITING
Toulouse
Germany
Hämatologie-Onkologie im Zentrum MVZ GmbH
RECRUITING
Augsburg
Schwanebecker Chaussee 50
ACTIVE_NOT_RECRUITING
Berlin
Teutoburger Str. 60
RECRUITING
Bielefeld
Josef-Albers-Str.70
RECRUITING
Bottrop
Studien GbR Braunschweig
RECRUITING
Braunschweig
Hämato-Onkologische Praxis im Medicum
RECRUITING
Bremen
St. Elisabeth Krankenhaus GmbH
RECRUITING
Cologne
St. Johannes Hospital
RECRUITING
Dortmund
Klinikum Esslingen
RECRUITING
Esslingen Am Neckar
MVZ II der Niels Stensen Kliniken
RECRUITING
Georgsmarienhütte
Moorkamp 2-6
RECRUITING
Hamburg
Edgar-von-Gierke-Straße 2
ACTIVE_NOT_RECRUITING
Karlsruhe
Elisabeth Krankenhaus Brustzentrum
RECRUITING
Kassel
InVO - Institut für Versorgungsforschung in der Onkologie GbR / Praxis für Hämatologie und Onkologie
RECRUITING
Koblenz
Universitätsklinikum Mannheim
RECRUITING
Mannheim
Elisabethenstr. 19, 88212 Ravensburg
RECRUITING
Ravensburg
Harsefelderstraße 8
ACTIVE_NOT_RECRUITING
Stade
Böheimstr. 37
ACTIVE_NOT_RECRUITING
Stuttgart
Calwerstrasse 7
ACTIVE_NOT_RECRUITING
Tübingen
Klinikum Worms Frauenklinik
RECRUITING
Worms
Helios University Hospital University Witten/Herdecke
RECRUITING
Wuppertal
Ireland
St James's Hospital
RECRUITING
Dublin
Spain
Medical Oncology Unit. A Coruña University Hospital
RECRUITING
A Coruña
ICO Badalona - Hospital Germans Trias I Pujol
RECRUITING
Badalona
Hospital Universitary of Cruces
RECRUITING
Barakaldo
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario San Pedro de Alcántara
RECRUITING
Cáceres
Consorcio Hospitalario Provincial de Castellón
RECRUITING
Castellon
Hospital General Universitario De Elche
RECRUITING
Elche
Hospital Galdakao
RECRUITING
Galdakao
Hospital Universitario Clínico San Cecilio
RECRUITING
Granada
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Hospital Universitario de Jaen
RECRUITING
Jaén
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Althaia Xarxa Assistencial de Manresa
RECRUITING
Manresa
Hospital Universitario Morales Meseguer
RECRUITING
Murcia
Clínica Universidad de Navarra - Madrid
RECRUITING
Pamplona
HU Marqués de Valdecilla
RECRUITING
Santander
Hospital Quironsalud Sagrado Corazón
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Hospital Clinico Universitario de Valladolid
RECRUITING
Valladolid
Isabel la Catolica nº 1-3
RECRUITING
Zaragoza
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date: 2022-12-12
Estimated Completion Date: 2031-08
Participants
Target number of participants: 1514
Treatments
Experimental: Sacituzumab govitecan-hziy (SG) + 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.
Active_comparator: Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + 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.
Related Therapeutic Areas
Sponsors
Collaborators: Alliance Foundation Trials, LLC., NSABP Foundation Inc, GBG Forschungs GmbH
Leads: Gilead Sciences