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ACTIVE NOT RECRUITING

NCT05382286

PHASE3

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

Official title: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

443

Start Date

2022-07-25

Completion Date

2027-02

Last Updated

2025-09-18

Healthy Volunteers

Conditions

Triple Negative Breast Cancer PD-L1 Positive

Interventions

DRUG

Sacituzumab Govitecan-hziy

Administered intravenously

DRUG

Pembrolizumab

Administered intravenously

DRUG

Paclitaxel

Administered intravenously

DRUG

nab-Paclitaxel

Administered intravenously

DRUG

Gemcitabine

Administered intravenously

DRUG

Carboplatin

Administered intravenously

Key Inclusion Criteria: * Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening. * Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence. * Individuals presenting with de novo metastatic TNBC are eligible for this study. * TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen. * Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Demonstrates adequate organ function * Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease. Key Exclusion Criteria: * Positive serum pregnancy test or women who are lactating. * Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor. * Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment. * Individuals may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible. * Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor. * Have an active second malignancy. * Have active serious infection requiring antibiotics. * Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. * Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. * Has an active autoimmune disease that has required systemic treatment in the past 2 years. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (504)

Alaska Oncology and Hematology

Anchorage, Alaska, United States

Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd

Tucson, Arizona, United States

Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd.

Tucson, Arizona, United States

Arizona Oncology Associates, PC-Hope

Tucson, Arizona, United States

Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road

Tucson, Arizona, United States

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, United States

Genesis Cancer and Blood Institute,1456 Higdon Ferry Road Suite B.

Hot Springs, Arkansas, United States

Saint Bernards Medical Center

Jonesboro, Arkansas, United States

Saint Bernards Medical Center,4000 Linwood Drive

Paragould, Arkansas, United States

University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200

Burbank, California, United States

University of California Irvine Health Chao Family,1640 Newport Blvd

Costa Mesa, California, United States

City of Hope

Duarte, California, United States

University of California San Diego Moores Cancer

La Jolla, California, United States

University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200

Laguna Hills, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

City of Hope,1601 Avocado Ave

Newport, California, United States

University of California Irvine Health Chao Family

Orange, California, United States

City of Hope,209 Fair Oaks Ave

Pasadena, California, United States

University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240

San Luis Obispo, California, United States

Sansum Clinic

Santa Barbara, California, United States

University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600

Santa Monica, California, United States

University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304

Santa Monica, California, United States

University of California Los Angeles - Jonsson Comprehensive Cancer Center

Santa Monica, California, United States

St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare

Santa Rosa, California, United States

Sansum Clinic,2040 Viborg Road

Solvang, California, United States

City of Hope,5215 Torrance Blvd

Torrance, California, United States

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

City of Hope,1100 San Bernardino Rd

Upland, California, United States

University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100

Westlake Village, California, United States

Rocky Mountain Cancer Centers,1700 South Potomac Street

Aurora, Colorado, United States

Rocky Mountain Cancer Centers

Boulder, Colorado, United States

Rocky Mountain Cancer Centers,2312 N. Nevada Avenue

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers,6031 E. Woodman Rd.

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers,4700 E. Hale Parkway

Denver, Colorado, United States

Rocky Mountain Cancer Centers,11750 West 2nd Place

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers,22 West Dry Creek Circle

Littleton, Colorado, United States

Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway

Lone Tree, Colorado, United States

Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210

Longmont, Colorado, United States

Rocky Mountain Cancer Centers,3676 Parker Blvd

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers,525 W. 15th Street

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers,8820 Huron Street

Thornton, Colorado, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Advent Health Medical Group

Altamonte Springs, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,750 Orienta Ave

Altamonte Springs, Florida, United States

University of Miami - Sylvester Comprehensive Cancer Center,2801 NE 213th St

Aventura, Florida, United States

Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 A

Bonita Springs, Florida, United States

Florida Cancer Specialists,3630 Manatee Avenue West

Bradenton, Florida, United States

Florida Cancer Specialists,5985 Silver Falls Run

Bradenton, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,403 S. Kings Ave.

Brandon, Florida, United States

Florida Cancer Specialists,1030 Commerce Creek Blvd

Cape Coral, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,3280 McMullen Booth Road

Clearwater, Florida, United States

University of Miami - Sylvester Comprehensive Cancer Center,5555 Ponce De Leon Blvd

Coral Gables, Florida, United States

SCRI - Florida Cancer Specialists - West Palm Beach,224 Memorial Medical Parkway, Suite 300

Daytona Beach, Florida, United States

University of Miami - Sylvester Comprehensive Cancer Center,1192 East Newport Center Drive

Deerfield Beach, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Florida Cancer Specialists,8981 Colonial Center Drive

Fort Myers, Florida, United States

Florida Cancer Specialists,8260 Gladiolus Dr

Fort Myers, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,6420 W. Newberry Road

Gainesville, Florida, United States

University of Miami - Sylvester Comprehensive Cancer Center,3850 Hollywood Blvd

Hollywood, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,100 Highland Avenue

Largo, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,521 North Lecanto Highway

Lecanto, Florida, United States

University of Miami - Sylvester Comprehensive Cancer Center,1400 NW 12th Ave

Miami, Florida, United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States

University of Miami - Sylvester Comprehensive Cancer Center,8932 S.W. 97 Ave

Miami, Florida, United States

Florida Cancer Specialists,1100 Goodlette Road

Naples, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,4945 SW 49th Place

Ocala, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,2824 Enterprise Rd

Orange City, Florida, United States

Advent Health Medical Group,2501 North Orange Ave

Orlando, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,70 W. Gore Street

Orlando, Florida, United States

University of Miami - Sylvester Comprehensive Cancer Center,8100 SW 10 Street

Plantation, Florida, United States

Florida Cancer Specialists,22395 Edgewater Drive

Port Charlotte, Florida, United States

Florida Cancer Specialists,600 North Cattlemen Road

Sarasota, Florida, United States

Florida Cancer Specialists,1970 Golf Street

Sarasota, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,7154 Medical Center Drive

Spring Hill, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,1201 Fifth Avenue North

St. Petersburg, Florida, United States

SCRI - Florida Cancer Specialists - North Region R

St. Petersburg, Florida, United States

SCRI - Florida Cancer Specialists - West Palm Beach,301 SE Ocean Blvd, Suite 102

Stuart, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,3402 West Dr. Martin Luther King Jr. Boulevard

Tampa, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,4100 Waterman Way

Tavares, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,1400 US Highway 441 N

The Villages, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,9320 State Road 54

Trinity, Florida, United States

Florida Cancer Specialists,836 Sunset Lake Blvd

Venice, Florida, United States

SCRI - Florida Cancer Specialists - West Palm Beach,3730 7th Terrace, Suite 101

Vero Beach, Florida, United States

SCRI - Florida Cancer Specialists - West Palm Beach,1037 S. State Road 7, Bldg B, Suite 303

Wellington, Florida, United States

SCRI - Florida Cancer Specialists - West Palm Beach

West Palm Beach, Florida, United States

SCRI - Florida Cancer Specialists - North Region R,460 N Orlando Ave

Winter Park, Florida, United States

Northside Hospital,125 King Avenue

Athens, Georgia, United States

Piedmont Cancer Institute - Atlanta,1267 Hwy 54W