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Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
Sponsor: Gilead Sciences
Summary
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.
Official title: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
623
Start Date
2022-07-20
Completion Date
2028-07
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
Sacituzumab Govitecan-hziy
Administered intravenously
Paclitaxel
Administered intravenously
nab-Paclitaxel
Administered intravenously
Gemcitabine
Administered intravenously
Carboplatin
Administered intravenously
Locations (363)
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
University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200
Burbank, 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
University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240
San Luis Obispo, 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
Torrance Memorial Physician Network - Cancer Care
Torrance, 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
AdventHealth Medical Group
Altamonte Springs, Florida, United States
Florida Cancer Specialists - North Region Research Office,750 Orienta Ave
Altamonte Springs, 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
Florida Cancer Specialists - North Region Research Office,403 S. Kings Ave.
Brandon, Florida, United States
Florida Cancer Specialists,1030 Commerce Creek Blvd
Cape Coral, Florida, United States
Florida Cancer Specialists - North Region Research Office,3280 McMullen Booth Road
Clearwater, 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
Florida Cancer Specialists - North Region Research Office,6420 W. Newberry Road
Gainesville, Florida, United States
Florida Cancer Specialists - North Region Research Office,100 Highland Avenue
Largo, Florida, United States
Florida Cancer Specialists - North Region Research Office,521 North Lecanto Highway
Lecanto, Florida, United States
Florida Cancer Specialists,1100 Goodlette Road
Naples, Florida, United States
Florida Cancer Specialists,681 4th Avenue North
Naples, Florida, United States
Florida Cancer Specialists - North Region Research Office,4945 SW 49th Place
Ocala, Florida, United States
Florida Cancer Specialists - North Region Research Office,2824 Enterprise Rd
Orange City, Florida, United States
AdventHealth Medical Group,2501 North Orange Ave
Orlando, Florida, United States
Florida Cancer Specialists - North Region Research Office,70 W. Gore Street
Orlando, 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
Florida Cancer Specialists - North Region Research Office,7154 Medical Center Drive
Spring Hill, Florida, United States
Florida Cancer Specialists - North Region Research Office,1201 Fifth Avenue North
St. Petersburg, Florida, United States
Florida Cancer Specialists - North Region Research Office
St. Petersburg, Florida, United States
Florida Cancer Specialists - North Region Research Office,3402 West Dr. Martin Luther King Jr. Boulevard
Tampa, Florida, United States
Florida Cancer Specialists - North Region Research Office,4100 Waterman Way
Tavares, Florida, United States
Florida Cancer Specialists - North Region Research Office,1400 US Highway 441 N
The Villages, Florida, United States
Florida Cancer Specialists - North Region Research Office,9320 State Road 54
Trinity, Florida, United States
Florida Cancer Specialists,901 South Tamiami Trail
Venice, Florida, United States
Florida Cancer Specialists,836 Sunset Lake Blvd
Venice, Florida, United States
Florida Cancer Specialists - North Region Research Office,460 N Orlando Ave
Winter Park, Florida, United States
Northside Hospital,125 King Avenue
Athens, Georgia, United States
Northside Hospital,5670 Peachtree Dunwoody Rd.
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Northside Hospital,308 Deep South Farm Rd, Suite 200
Blairsville, Georgia, United States
Northside Hospital,228 Riverstone Dr.
Canton, Georgia, United States
Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,157 Clinic Avenue
Carrollton, Georgia, United States
Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,100 Market Place Blvd
Cartersville, Georgia, United States
Northside Hospital,1505 Northside Blvd, Suite 4600
Cumming, Georgia, United States
Northside Hospital,3855 Pleasant Hill Rd., Suite 480
Duluth, Georgia, United States
Northside Hospital,308 Coliseum Dr.
Macon, Georgia, United States
Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC
Marietta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1 Kish Hospital Drive
DeKalb, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,10 Health Services Drive
DeKalb, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,300 Randall Road
Geneva, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,304 Randall Road
Geneva, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1000 N. Westmoreland Road
Lake Forest, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4405 Weaver Parkway
Warrenville, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4455 Weaver Parkway
Warrenville, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,25 N Winfield Road
Winfield, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Norton Cancer Institute - Saint Matthews,234 E. Gray Strret
Louisville, Kentucky, United States
Norton Cancer Institute - Saint Matthews,676 S. Floyd Street
Louisville, Kentucky, United States
Norton Cancer Institute - Saint Matthews
Louisville, Kentucky, United States
Norton Cancer Institute - Saint Matthews,4955 Norton Healthcare Blvd
Louisville, Kentucky, United States
Cancer Institute Ascension Saint Agnes
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
The West Clinic, PLLC dba West Cancer Center,7668 Airways Blvd
Southaven, Mississippi, United States
New York Cancer & Blood Specialists - Port Jeffers,72 East Main St.
Babylon, New York, United States
New York Cancer & Blood Specialists - Port Jeffers,1 Delaware Dr.
New Hyde Park, New York, United States
New York Cancer & Blood Specialists - Port Jeffers,365 East Main St.
Patchogue, New York, United States
New York Cancer & Blood Specialists - Port Jeffers,1500 Rte, 112, Building 4
Port Jefferson, New York, United States
New York Cancer & Blood Specialists - Port Jeffers,49 Rte. 347, Newconset Hwy
Port Jefferson Station, New York, United States
New York Cancer & Blood Specialists - Port Jeffers
Port Jefferson Station, New York, United States
New York Cancer & Blood Specialists - Port Jeffers,750 Old County Rd. Suite 4
Riverhead, New York, United States
New York Cancer & Blood Specialists - Port Jeffers,12 East 86th St, Suite 4
The Bronx, New York, United States
New York Cancer & Blood Specialists - Port Jeffers,2330 Eastchester Road, Suite 360
The Bronx, New York, United States
Novant Health Cancer Institute - Forsyth,125 Queens Road, Suite 650
Charlotte, North Carolina, United States
Novant Health Cancer Institute - Forsyth,2131 S. 17th Street
Wilmington, North Carolina, United States
Novant Health Cancer Institute - Forsyth
Winston-Salem, North Carolina, United States
Magee-Womens Hospital of UPMC,2500 West 12th Street
Erie, Pennsylvania, United States