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 (ASCENT-05)

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

Phase 3

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.
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 known 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 (111)

Alabama Oncology

Birmingham, Alabama, United States, 35243

Clearview Cancer Institute

Huntsville, Alabama, United States, 35805

Palo Verde Hematology Oncology

Glendale, Arizona, United States, 85304

Arizona Oncology Associates

Prescott Valley, Arizona, United States, 86314

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

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

Norwalk Hospital

Danbury, Connecticut, United States, 06810

Stamford Hospital

Stamford, Connecticut, United States, 06902

Morton Plant Hospital - Bay Care

Clearwater, Florida, United States, 00337

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

Sacred Heart Medical Oncology Group

Pensacola, Florida, United States, 32504

St. Joseph's Hospital

Tampa, Florida, United States, 33614

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

University of Illinois

Chicago, Illinois, United States, 60612

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

Investigative Clinical Research of Indiana, LLC

Indianapolis, Indiana, United States, 46260

IU Health Arnett Hospital

Lafayette, Indiana, United States, 47904

Mercy Medical Center

Cedar Rapids, Iowa, United States, 52403

Mission Cancer & Blood - John Stoddard Cancer Center

Des Moines, Iowa, United States, 50309

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

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States, 49503

Ascension Providence Hospital Southfield Cancer Center

Southfield, Michigan, United States, 48075

Virginia Piper Cancer Center (Allina Health)

Minneapolis, Minnesota, United States, 55407

Metro Minnesota Community Oncology

Saint Louis Park, Minnesota, United States, 55426

Baptist Clinical Research Institute

Saint Louis, Missouri, United States, 63131

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

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

Hematology Oncology Associates of Central New York, PC

East Syracuse, New York, United States, 13057

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

Clinical Research Alliance

Westbury, New York, United States, 11590

White Plains Hospital Physician Associates

White Plains, New York, United States, 10601

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States, 28374

UNC Rex Cancer Center

Raleigh, North Carolina, United States, 27607

Good Samaritan Hospital

Cincinnati, Ohio, United States, 45220

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States, 45242

Ohio Health Research Institute

Columbus, Ohio, United States, 43214

Anita Stewart Oncology Center

Columbus, Ohio, United States, 43221

MultiCare Regional Cancer Center - Tacoma

Middletown, Ohio, United States, 45042

Toledo Clinic Cancer Center

Toledo, Ohio, United States, 43623

Samaritan Hospital

Corvallis, Oregon, United States, 97330

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States, 97401

Providence Cancer Institute - Oncology Clinical Trials

Portland, Oregon, United States, 97213

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

Cancer Care Associates of York

York, Pennsylvania, United States, 17403

Providence Health

Providence, Rhode Island, United States, 02905

Monument Health Cancer Care Institute

Rapid City, South Dakota, United States, 57701

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

Center for Biomedical Research, LLC

Knoxville, Tennessee, United States, 37909

University of Tennessee

Knoxville, Tennessee, United States, 37920

Texas Oncology

Austin, Texas, United States, 78731

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States, 79410