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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Sacituzumab govitecan-hziy (SG)
    Administered intravenously
    Other names:
    • GS-0132
    • IMMU-132
    • Trodelvy™
  • Drug: Pembrolizumab
    Administered intravenously
    Other names:
    • KEYTRUDA®
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.
  • Drug: Pembrolizumab
    Administered intravenously
    Other names:
    • KEYTRUDA®
  • Drug: Capecitabine
    Tablets administered orally
    Other names:
    • Xeloda

Recruiting Locations

Alabama Oncology
Birmingham 4049979, Alabama 4829764 35243

Clearview Cancer Institute
Huntsville 4068590, Alabama 4829764 35805

Palo Verde Hematology Oncology
Glendale 5295985, Arizona 5551752 85304

Alta Bates Summit Medical Center
Berkeley 5327684, California 5332921 94704

PIH Health Whittier Hospital
Downey 5343858, California 5332921 90241

Compassionate Cancer Care Medical Group - Inc
Fountain Valley 5350207, California 5332921 92708

Los Angeles Cancer Network
Los Angeles 5368361, California 5332921 90017

Cedars-Sinai Cancer at Beverly Hills
Los Angeles 5368361, California 5332921 90048

Hoag Memorial Hospital Presbyterian
Newport Beach 5376890, California 5332921 92663

Sutter Institute for Medical Research
Sacramento 5389489, California 5332921 95816

UCSF Medical Center
San Francisco 5391959, California 5332921 94143

Sansum Clinic
Santa Barbara 5392952, California 5332921 93105

Stockton Hematology Oncology Medical Group
Stockton 5399020, California 5332921 95204

Stamford Hospital
Stamford 4843564, Connecticut 4831725 06902

Mayo Clinic Florida
Jacksonville 4160021, Florida 4155751 32224

Cancer Specialists of North Florida
Jacksonville 4160021, Florida 4155751 32256

Jupiter Medical Center
Jupiter 4160610, Florida 4155751 33458

Mount Sinai Comprehensive Cancer Center
Miami Beach 4164143, Florida 4155751 33140

Cancer Care Centers of Brevard, Inc
Palm Bay 4167499, Florida 4155751 32909

Memorial Healthcare System
Pembroke Pines 4168139, Florida 4155751 33028

Sylvester Comprehensive Cancer Center
Plantation 4168782, Florida 4155751 33324

University Cancer & Blood Center, LLC.
Athens 4180386, Georgia 4197000 30607

Piedmont Cancer Institute
Atlanta 4180439, Georgia 4197000 30318

Northside Hospital
Atlanta 4180439, Georgia 4197000 30342

Northwest Georgia Oncology Centers, PC
Marietta 4207783, Georgia 4197000 30060

Pearlman Cancer Center
Valdosta 4228147, Georgia 4197000 31602

Kootenai Health
Coeur d'Alene 5589173, Idaho 5596512 83814

Northwestern Medicine
Chicago 4887398, Illinois 4896861 60611

Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637

NorthShore University Healthsystem
Evanston 4891382, Illinois 4896861 60201

Edward Hospital
Naperville 4903279, Illinois 4896861 60540

Carle Cancer Center
Urbana 4914570, Illinois 4896861 61801

Franciscan Health Indianapolis
Indianapolis 4259418, Indiana 4921868 46237

Mission Cancer & Blood - John Stoddard Cancer Center
Des Moines 4853828, Iowa 4862182 50309

University of Iowa Hospitals and Clinics
Iowa City 4862034, Iowa 4862182 52242

Norton Healthcare, Inc.
Louisville 4299276, Kentucky 6254925 40207

Mercy Health
Paducah 4048662, Kentucky 6254925 42003

Mary Bird Perkins Cancer Center
Baton Rouge 4315588, Louisiana 4331987 70809

New England Cancer Specialists
Scarborough 4977882, Maine 4971068 04074

Sinai Hospital of Baltimore, Inc.
Baltimore 4347778, Maryland 4361885 21215

St. Agnes Hospital
Baltimore 4347778, Maryland 4361885 21229

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore 4347778, Maryland 4361885 21231

Medstar Franklin Square Medical Center
Baltimore 4347778, Maryland 4361885 21237

James M Stockman Cancer Institute
Frederick 4355585, Maryland 4361885 21702

Greater Baltimore Medical Center
Towson 4371582, Maryland 4361885 21204

Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02115

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215

Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215

Dana-Farber Cancer Institude at Merrimack Valley
Methuen 4943828, Massachusetts 6254926 01844

Dana Farber Cancer Institute @ Milford Regional Hospital
Milford 4943958, Massachusetts 6254926 01757

Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
South Weymouth 4951568, Massachusetts 6254926 02190

University of Massachusetts Worcester
Worcester 4956184, Massachusetts 6254926 01655

Cancer and Hematology Centers of Western Michigan
Grand Rapids 4994358, Michigan 5001836 49503

William Beaumont Hospital
Royal Oak 5007804, Michigan 5001836 48073

Minnesota Oncology Hematology, PA
Maplewood 5036588, Minnesota 5037779 55109

Virginia Piper Cancer Center (Allina Health)
Minneapolis 5037649, Minnesota 5037779 55407

University of Minnesota Medical Center, Fairview
Minneapolis 5037649, Minnesota 5037779 55455

Mayo Clinic Rochester
Rochester 5043473, Minnesota 5037779 55905

Metro Minnesota Community Oncology
Saint Louis Park 5045021, Minnesota 5037779 55426

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110

Baptist Clinical Research Institute
St Louis 4407066, Missouri 4398678 63131

Mary Lanning Healthcare - Morrison Cancer Center
Hastings 5069802, Nebraska 5073708 68901

Oncology Hematology West - Methodist
Omaha 5074472, Nebraska 5073708 68114

Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
Omaha 5074472, Nebraska 5073708 68124

Regional Cancer Care Associates LLC
East Brunswick 5097402, New Jersey 5101760 08816

Hunterdon Medical Center
Flemington 5098124, New Jersey 5101760 08822

Rutgers Health
New Brunswick 5101717, New Jersey 5101760 08901

Overlook Medical Center
Summit 5105127, New Jersey 5101760 07901

University of New Mexico
Albuquerque 5454711, New Mexico 5481136 87131

San Juan Oncology Associates
Farmington 5467328, New Mexico 5481136 87401

Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638 14263

Hematology Oncology Associates of Central New York, PC
East Syracuse 5116079, New York 5128638 13057

Northwell Health
Lake Success 5123853, New York 5128638 11042

Laura and Isaac Perlmutter Cancer Canter
New York 5128581, New York 5128638 10016

Lipson Cancer Institute - Linden Oaks
Rochester 5134086, New York 5128638 14618

New York Cancer and Blood Specialists
Shirley 5138022, New York 5128638 11967

Stony Brook Medicine
Stony Brook 5139865, New York 5128638 11794

SUNY Upstate Medical University
Syracuse 5140405, New York 5128638 13210

White Plains Hospital Physician Associates
White Plains 5144336, New York 5128638 10601

Lineberger Comprehensive Cancer Center
Chapel Hill 4460162, North Carolina 4482348 27514

Duke Cancer Institute
Durham 4464368, North Carolina 4482348 27710

Cone Health Medical Group (Moses Cone Health System)
Greensboro 4469146, North Carolina 4482348 27403

Atrium Health Wake Forest Baptist
Winston-Salem 4499612, North Carolina 4482348 27157

Good Samaritan Hospital
Cincinnati 4508722, Ohio 5165418 45220

Oncology Hematology Care, Inc.
Cincinnati 4508722, Ohio 5165418 45242

Ohio State University CRS
Columbus 4509177, Ohio 5165418 43212

Ohio Health Research Institute
Columbus 4509177, Ohio 5165418 43214

Columbus NCORP
Columbus 4509177, Ohio 5165418 43215

Anita Stewart Oncology Center
Columbus 4509177, Ohio 5165418 43221

St. Charles Health System, Inc. DBA St. Charles Medical Center
Bend 5713587, Oregon 5744337 97701

Samaritan Hospital
Corvallis 5720727, Oregon 5744337 97330

Willamette Valley Cancer Institute and Research Center
Eugene 5725846, Oregon 5744337 97401

Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239

Lancaster General Health
Lancaster 5197079, Pennsylvania 6254927 17601

University of Pennsylvania Abramson Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19104

UPMC Magee-Womens Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15213

Guthrie Clinical Research
Sayre 5211037, Pennsylvania 6254927 18840

Lankenau Medical Center
Wynnewood 5220230, Pennsylvania 6254927 19106

Cancer Care Associates of York
York 4562407, Pennsylvania 6254927 17403

Providence Health
Providence 5224151, Rhode Island 5224323 02905

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425

Spartanburg Medical Center
Spartanburg 4597200, South Carolina 4597040 29303

Monument Health Cancer Care Institute
Rapid City 5768233, South Dakota 5769223 57701

Avera Cancer Institute
Sioux Falls 5231851, South Dakota 5769223 57105

University of Tennessee
Knoxville 4634946, Tennessee 4662168 37920

Texas Oncology
Austin 4671654, Texas 4736286 78731

Texas Oncology
El Paso 5520993, Texas 4736286 79902

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

Texas Oncology
San Antonio 4726206, Texas 4736286 78240

Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030 84112

University of Virginia
Charlottesville 4752031, Virginia 6254928 22908

Inova Fairfax Hospital
Fairfax 4758023, Virginia 6254928 22031

Oncology and Hematology Associates of Southwest Virginia, Inc
Wytheville 4794837, Virginia 6254928 24382

Providence Regional Cancer System
Lacey 5800112, Washington 5815135 98503

Northwest Medical Specialties, PLLC
Puyallup 5807575, Washington 5815135 98373

West Virginia University Hospital
Morgantown 4815352, West Virginia 4826850 26505

Ascension St. Francis Reiman Cancer Center
Franklin 5253710, Wisconsin 5279468 53132

More Details

NCT ID
NCT05633654
Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.