Study Details

OVERVIEW

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

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Triple Negative Breast Cancer

Gender

N/A

Date

December 2022 - June 2027

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Sacituzumab govitecan-hziy (SG), Pembrolizumab, Capecitabine

Eligibility Information

Inclusion Criteria

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.

Exclusion Criteria

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.

Locations

Locations (224)

Alabama Oncology

Birmingham, Alabama, United States, 35243

Clearview Cancer Institute

Huntsville, Alabama, United States, 35805

Palo Verde Hematology Oncology

Glendale, Arizona, United States, 85304

Mayo Clinic Hospital

Phoenix, Arizona, United States, 85054

Arizona Oncology Associates

Prescott Valley, Arizona, United States, 86314

Alta Bates Summit Medical Center

Berkeley, California, United States, 94704

Community Cancer Institute

Clovis, California, United States, 93611

PIH Health Whittier Hospital

Downey, California, United States, 90241

Compassionate Cancer Care Medical Group - Inc

Fountain Valley, California, United States, 92708

Los Angeles Cancer Network

Los Angeles, California, United States, 90017

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Cedars-Sinai Cancer at Beverly Hills

Los Angeles, California, United States, 90048

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Emad Ibrahim, MD, INC

Redlands, California, United States, 92373

Sutter Institute for Medical Research

Sacramento, California, United States, 95816

UCSF Medical Center

San Francisco, California, United States, 94143

Sansum Clinic

Santa Barbara, California, United States, 93105

Stockton Hematology Oncology Medical Group

Stockton, California, United States, 95204

University of Colorado Cancer Center

Aurora, Colorado, United States, 80045

Norwalk Hospital

Danbury, Connecticut, United States, 06810

Stamford Hospital

Stamford, Connecticut, United States, 06902

Morton Plant Hospital - Bay Care

Clearwater, Florida, United States, 00337

University of Florida

Gainesville, Florida, United States, 32610

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

Cancer Specialists of North Florida

Jacksonville, Florida, United States, 32256

Jupiter Medical Center

Jupiter, Florida, United States, 33458

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States, 33140

Midland Florida Clinical Research Center, L

Orange City, Florida, United States, 32763

Orlando Health

Orlando, Florida, United States, 32806

Cancer Care Centers of Brevard, Inc

Palm Bay, Florida, United States, 32909

Memorial Healthcare System

Pembroke Pines, Florida, United States, 33028

Sacred Heart Medical Oncology Group

Pensacola, Florida, United States, 32504

Sylvester Comprehensive Cancer Center

Plantation, Florida, United States, 33324

Cleveland Clinic Florida, Martin North Hospital

Stuart, Florida, United States, 34994

St. Joseph's Hospital

Tampa, Florida, United States, 33614

Weston Hospital

Weston, Florida, United States, 33331

University Cancer & Blood Center, LLC.

Athens, Georgia, United States, 30607

Piedmont Cancer Institute

Atlanta, Georgia, United States, 30318

Northside Hospital

Atlanta, Georgia, United States, 30342

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, United States, 30060

Pearlman Cancer Center

Valdosta, Georgia, United States, 31602

St Lukes Mountain States Tumor Institute

Boise, Idaho, United States, 83712

Kootenai Health

Coeur d'Alene, Idaho, United States, 83814

Northwestern Medicine

Chicago, Illinois, United States, 60611

Rush University Medical Center

Chicago, Illinois, United States, 60612

University of Illinois

Chicago, Illinois, United States, 60612

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

NorthShore University Healthsystem

Evanston, Illinois, United States, 60201

Edward Hospital

Naperville, Illinois, United States, 60540

West Suburban Medical Center- River Forest

River Forest, Illinois, United States, 60305

Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore

Skokie, Illinois, United States, 60076

Springfield Clinic LLP

Springfield, Illinois, United States, 62702

Carle Cancer Center

Urbana, Illinois, United States, 61801

Franciscan Health Indianapolis

Indianapolis, Indiana, United States, 46237

Investigative Clinical Research of Indiana, LLC

Indianapolis, Indiana, United States, 46260

IU Health Arnett Hospital

Lafayette, Indiana, United States, 47904

Franciscan Health Munster

Munster, Indiana, United States, 46321

Mercy Medical Center

Cedar Rapids, Iowa, United States, 52403

Mission Cancer & Blood - John Stoddard Cancer Center

Des Moines, Iowa, United States, 50309

University of Iowa Hospitals and Clinics

Fairfield, Iowa, United States, 52556

University of Kentucky

Lexington, Kentucky, United States, 40536

Norton Healthcare, Inc.

Louisville, Kentucky, United States, 40207

Mercy Health

Paducah, Kentucky, United States, 42003

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States, 70809

University Medical Center New Orleans

New Orleans, Louisiana, United States, 70112

New England Cancer Specialists

Scarborough, Maine, United States, 04074

Sinai Hospital of Baltimore, Inc.

Baltimore, Maryland, United States, 21215

St. Agnes Hospital

Baltimore, Maryland, United States, 21229

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States, 21231

Medstar Franklin Square Medical Center

Baltimore, Maryland, United States, 21237

American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States, 20817

James M Stockman Cancer Institute

Frederick, Maryland, United States, 21702

Greater Baltimore Medical Center

Towson, Maryland, United States, 21204

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Baystate Medical Center Inc.

Springfield, Massachusetts, United States, 01199

University of Massachusetts Worcester

Worcester, Massachusetts, United States, 01655

Henry Ford Health System

Detroit, Michigan, United States, 48202

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States, 49503

Ascension

Grosse Pointe Woods, Michigan, United States, 48236

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

Ascension Providence Hospital Southfield Cancer Center

Southfield, Michigan, United States, 48075

Trinity Health St. Joseph Mercy Ann Arbor

Ypsilanti, Michigan, United States, 48197

Minnesota Oncology Hematology, PA

Maplewood, Minnesota, United States, 55109

Virginia Piper Cancer Center (Allina Health)

Minneapolis, Minnesota, United States, 55407

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, United States, 55455

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Metro Minnesota Community Oncology

Saint Louis Park, Minnesota, United States, 55426

Baptist Clinical Research Institute

Saint Louis, Missouri, United States, 63131

Mercy Hospital

Saint Louis, Missouri, United States, 63141

Mary Lanning Healthcare - Morrison Cancer Center

Hastings, Nebraska, United States, 68901

Oncology Hematology West - Methodist

Omaha, Nebraska, United States, 68114

Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)

Omaha, Nebraska, United States, 68124

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

Cancer Care & Hematology Specialists

Reno, Nevada, United States, 89511

Regional Cancer Care Associates LLC

East Brunswick, New Jersey, United States, 08816

Hunterdon Medical Center

Flemington, New Jersey, United States, 08822

Summit Medical Group, P.A.

Florham Park, New Jersey, United States, 07932

Rutgers Health

New Brunswick, New Jersey, United States, 08901

Overlook Medical Center

Summit, New Jersey, United States, 07901

University of New Mexico

Albuquerque, New Mexico, United States, 87131

San Juan Oncology Associates

Farmington, New Mexico, United States, 87401

New York Oncology Hematology (NYOH)

Amsterdam, New York, United States, 12010

Montefiore Medical Center

Bronx, New York, United States, 10467

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Hematology Oncology Associates of Central New York, PC

East Syracuse, New York, United States, 13057

Northwell Health

Lake Success, New York, United States, 11042

Laura and Isaac Perlmutter Cancer Canter

New York, New York, United States, 10016

Lipson Cancer Institute - Linden Oaks

Rochester, New York, United States, 14618

New York Cancer and Blood Specialists

Shirley, New York, United States, 11967

Stony Brook Medicine

Stony Brook, New York, United States, 11794

SUNY Upstate Medical University

Syracuse, New York, United States, 13210

Clinical Research Alliance

Westbury, New York, United States, 11590

White Plains Hospital Physician Associates

White Plains, New York, United States, 10601

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27514

Duke Cancer Institute

Durham, North Carolina, United States, 27710

Cone Health Medical Group (Moses Cone Health System)

Greensboro, North Carolina, United States, 27403

East Carolina University Health Medical Center

Greenville, North Carolina, United States, 27834

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States, 28374

UNC Rex Cancer Center

Raleigh, North Carolina, United States, 27607

UNC Nash Cancer Center

Rocky Mount, North Carolina, United States, 27804

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27157

Good Samaritan Hospital

Cincinnati, Ohio, United States, 45220

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States, 45242

Ohio State University CRS

Columbus, Ohio, United States, 43212

Ohio Health Research Institute

Columbus, Ohio, United States, 43214

Anita Stewart Oncology Center

Columbus, Ohio, United States, 43221

Toledo Clinic Cancer Center

Toledo, Ohio, United States, 43623

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

St. Charles Health System, Inc. DBA St. Charles Medical Center

Bend, Oregon, United States, 97701

Samaritan Hospital

Corvallis, Oregon, United States, 97330

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States, 97401

Asante Rogue Regional Medical Center

Medford, Oregon, United States, 97504

Providence Cancer Institute - Oncology Clinical Trials

Portland, Oregon, United States, 97213

Oregon Health & Science University

Portland, Oregon, United States, 97239

Saint Luke's University Hospital

Bethlehem, Pennsylvania, United States, 18015

Lancaster General Health

Lancaster, Pennsylvania, United States, 17601

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

Guthrie Clinical Research

Sayre, Pennsylvania, United States, 18840

Reading Hospital and Medical Center

West Reading, Pennsylvania, United States, 19611

Lankenau Medical Center

Wynnewood, Pennsylvania, United States, 19106

Cancer Care Associates of York

York, Pennsylvania, United States, 17403

Providence Health

Providence, Rhode Island, United States, 02905

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Spartanburg Medical Center

Spartanburg, South Carolina, United States, 29303

Monument Health Cancer Care Institute

Rapid City, South Dakota, United States, 57701

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

Ballad Health Cancer Care - Kingsport

Kingsport, Tennessee, United States, 37660

Center for Biomedical Research, LLC

Knoxville, Tennessee, United States, 37909

University of Tennessee

Knoxville, Tennessee, United States, 37920

Hendrick Health System

Abilene, Texas, United States, 79601

Texas Oncology

Austin, Texas, United States, 78731

Texas Oncology

El Paso, Texas, United States, 79902

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States, 79410

Texas Oncology

San Antonio, Texas, United States, 78240

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

University of Virginia

Charlottesville, Virginia, United States, 22908

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States, 23298

Oncology and Hematology Associates of Southwest Virginia, Inc

Wytheville, Virginia, United States, 24382

Providence Regional Cancer System

Lacey, Washington, United States, 98503

MultiCare Regional Cancer Center - Tacoma

Puyallup, Washington, United States, 98372

Northwest Medical Specialties, PLLC

Puyallup, Washington, United States, 98373

University of Washington

Renton, Washington, United States, 98055

Medical Oncology Associates

Spokane, Washington, United States, 99208

West Virginia University Hospital

Morgantown, West Virginia, United States, 26505

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States, 54911

Ascension St. Francis Reiman Cancer Center

Franklin, Wisconsin, United States, 53132

HSHS Saint Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, United States, 54303

University of Wisconsin

Madison, Wisconsin, United States, 53792

Macarthur Cancer Therapy Centre, Campbelltown Hospital

Campbelltown, New South Wales, Australia, 2560

Lake Macquarie Private Hospital

Gateshead, New South Wales, Australia, 2290

Monash Medical Centre

Clayton, Victoria, Australia, 3168

Pôle Santé Léonard De Vinci - ROC37

Chambray les Tours, France, 37170

Clinique Victor Hugo

Le Mans, France, 72000

Hôpital Privé Jean Mermoz

Lyon, France, 69008

Hopital Privé des Côtes d'Armor - Centre CARIO-HPCA

Plerin, France, 22190

Centre Eugène Marquis

Rennes cedex, France, 35042

Oncopole Claudius Regaud - IUCT-O

Toulouse, France, 31059

Hämatologie-Onkologie im Zentrum MVZ GmbH

Augsburg, Germany, 86150

Schwanebecker Chaussee 50

Berlin, Germany, 13125

Teutoburger Str. 60

Bielefeld, Germany, 33604

Josef-Albers-Str.70

Bottrop, Germany, 46236

Studien GbR Braunschweig

Braunschweig, Germany, 38100

Hämato-Onkologische Praxis im Medicum

Bremen, Germany, 28209

St. Johannes Hospital

Dortmund, Germany, 44137

Klinikum Esslingen

Esslingen, Germany, 73730

MVZ II der Niels Stensen Kliniken

Georgsmarienhütte, Germany, 49124

Moorkamp 2-6

Hamburg, Germany, 20357

Edgar-von-Gierke-Straße 2

Karlsruhe, Germany, 76137

Elisabeth Krankenhaus Brustzentrum

Kassel, Germany, 34117

InVO - Institut für Versorgungsforschung in der Onkologie GbR / Praxis für Hämatologie und Onkologie

Koblenz, Germany, 56068

St. Elisabeth Krankenhaus GmbH

Köln, Germany, 50935

Universitätsklinikum Mannheim

Mannheim, Germany, 68167

Elisabethenstr. 19, 88212 Ravensburg

Ravensburg, Germany, 88212

Harsefelderstraße 8

Stade, Germany, 21680

Böheimstr. 37

Stuttgart, Germany, 70199

Calwerstrasse 7

Tuebingen, Germany, 72076

Klinikum Worms Frauenklinik

Worms, Germany, 67550

Helios University Hospital University Witten/Herdecke

Wuppertal, Germany, 42283

St James's Hospital

Dublin, Ireland, D08NH41

Medical Oncology Unit. A Coruña University Hospital

A Coruña, Spain, 15006

ICO Badalona - Hospital Germans Trias I Pujol

Badalona, Spain, 08916

Hospital Universitary of Cruces

Barakaldo, Spain, 48903

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 8041

Hospital Universitario San Pedro de Alcántara

Caceres, Spain, 10003

Consorcio Hospitalario Provincial de Castellón

Castellón, Spain, 12002

Hospital General Universitario De Elche

Elche, Spain, 03203

Hospital Galdakao

Galdakao, Spain, 48960

Hospital Universitario Virgen de las Nieves

Granada, Spain, 18014

Hospital Universitario Clínico San Cecilio

Granada, Spain, 18016

Hospital Universitario de Jaen

Jaen, Spain, 23007

Hospital Universitario Virgen de la Victoria

Malaga, Spain, 29010

Althaia Xarxa Assistencial de Manresa

Manresa, Spain, 08242

Hospital Universitario Morales Meseguer

Murcia, Spain, 30008

Clínica Universidad de Navarra - Madrid

Pamplona, Spain, 31008

HU Marqués de Valdecilla

Santander, Spain, 39008

Hospital Universitario Virgen Macarena

Sevilla, Spain, 41009

Hospital Quironsalud Sagrado Corazón

Seville, Spain, 41010

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Hospital Clinico Universitario de Valladolid

Valladolid, Spain, 47003

Isabel la Catolica nº 1-3

Zaragoza, Spain, 50009

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)

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (224)

Alabama Oncology

Clearview Cancer Institute

Palo Verde Hematology Oncology

Mayo Clinic Hospital

Arizona Oncology Associates

Alta Bates Summit Medical Center

Community Cancer Institute

PIH Health Whittier Hospital

Compassionate Cancer Care Medical Group - Inc

Los Angeles Cancer Network

USC Norris Comprehensive Cancer Center

Cedars-Sinai Cancer at Beverly Hills

Hoag Memorial Hospital Presbyterian

Emad Ibrahim, MD, INC

Sutter Institute for Medical Research

UCSF Medical Center

Sansum Clinic

Stockton Hematology Oncology Medical Group

University of Colorado Cancer Center

Norwalk Hospital

Stamford Hospital

Morton Plant Hospital - Bay Care

University of Florida

Mayo Clinic Florida

Cancer Specialists of North Florida

Jupiter Medical Center

Mount Sinai Comprehensive Cancer Center

Midland Florida Clinical Research Center, L

Orlando Health

Cancer Care Centers of Brevard, Inc

Memorial Healthcare System

Sacred Heart Medical Oncology Group

Sylvester Comprehensive Cancer Center

Cleveland Clinic Florida, Martin North Hospital

St. Joseph's Hospital

Weston Hospital

University Cancer & Blood Center, LLC.

Piedmont Cancer Institute

Northside Hospital

Northwest Georgia Oncology Centers, PC

Pearlman Cancer Center

St Lukes Mountain States Tumor Institute

Kootenai Health

Northwestern Medicine

Rush University Medical Center

University of Illinois

University of Chicago Medical Center

NorthShore University Healthsystem

Edward Hospital

West Suburban Medical Center- River Forest

Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore

Springfield Clinic LLP

Carle Cancer Center

Franciscan Health Indianapolis

Investigative Clinical Research of Indiana, LLC

IU Health Arnett Hospital

Franciscan Health Munster

Mercy Medical Center

Mission Cancer & Blood - John Stoddard Cancer Center

University of Iowa Hospitals and Clinics

University of Kentucky

Norton Healthcare, Inc.

Mercy Health

Mary Bird Perkins Cancer Center

University Medical Center New Orleans

New England Cancer Specialists

Sinai Hospital of Baltimore, Inc.

St. Agnes Hospital

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

Medstar Franklin Square Medical Center