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ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05382299

Public ClinicalTrials.gov record NCT05382299. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 6, 2026, 7:24 PM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05382299
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
623 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 20, 2022 (Actual)
Primary completion
Jul 2028 (Estimated)
Completion
Jul 2028 (Estimated)
Last update posted
Apr 6, 2026

2022 – 2028

United States locations

U.S. sites
130
U.S. states
17
U.S. cities
95
Facility City State ZIP Site status
Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd Tucson Arizona 85704 —
Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd. Tucson Arizona 85704 —
Arizona Oncology Associates, PC-Hope Tucson Arizona 85711 —
Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road Tucson Arizona 85745 —
University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200 Burbank California 91505 —
University of California San Diego Moores Cancer La Jolla California 92093 —
University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200 Laguna Hills California 91505 —
University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240 San Luis Obispo California 93401 —
University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600 Santa Monica California 90404 —
University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304 Santa Monica California 90404 —
University of California Los Angeles - Jonsson Comprehensive Cancer Center Santa Monica California 90404 —
Torrance Memorial Physician Network - Cancer Care Torrance California 90505 —
University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100 Westlake Village California 91361 —
Rocky Mountain Cancer Centers,1700 South Potomac Street Aurora Colorado 80012 —
Rocky Mountain Cancer Centers Boulder Colorado 80303 —
Rocky Mountain Cancer Centers,2312 N. Nevada Avenue Colorado Springs Colorado 80907 —
Rocky Mountain Cancer Centers,6031 E. Woodman Rd. Colorado Springs Colorado 80923 —
Rocky Mountain Cancer Centers,4700 E. Hale Parkway Denver Colorado 80220 —
Rocky Mountain Cancer Centers,11750 West 2nd Place Lakewood Colorado 80228 —
Rocky Mountain Cancer Centers,22 West Dry Creek Circle Littleton Colorado 80120 —
Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway Lone Tree Colorado 80124 —
Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210 Longmont Colorado 80124 —
Rocky Mountain Cancer Centers,3676 Parker Blvd Pueblo Colorado 81008 —
Rocky Mountain Cancer Centers,525 W. 15th Street Pueblo Colorado 81008 —
Rocky Mountain Cancer Centers,8820 Huron Street Thornton Colorado 80260 —
AdventHealth Medical Group Altamonte Springs Florida 32701 —
Florida Cancer Specialists - North Region Research Office,750 Orienta Ave Altamonte Springs Florida 32701 —
Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 A Bonita Springs Florida 34135 —
Florida Cancer Specialists,3630 Manatee Avenue West Bradenton Florida 34205 —
Florida Cancer Specialists,5985 Silver Falls Run Bradenton Florida 34211 —
Florida Cancer Specialists - North Region Research Office,403 S. Kings Ave. Brandon Florida 33511 —
Florida Cancer Specialists,1030 Commerce Creek Blvd Cape Coral Florida 33909 —
Florida Cancer Specialists - North Region Research Office,3280 McMullen Booth Road Clearwater Florida 33761 —
Florida Cancer Specialists Fort Myers Florida 33901 —
Florida Cancer Specialists,8981 Colonial Center Drive Fort Myers Florida 33905 —
Florida Cancer Specialists,8260 Gladiolus Dr Fort Myers Florida 33908 —
Florida Cancer Specialists - North Region Research Office,6420 W. Newberry Road Gainesville Florida 32605 —
Florida Cancer Specialists - North Region Research Office,100 Highland Avenue Largo Florida 33770 —
Florida Cancer Specialists - North Region Research Office,521 North Lecanto Highway Lecanto Florida 34461 —
Florida Cancer Specialists,1100 Goodlette Road Naples Florida 34102 —
Florida Cancer Specialists,681 4th Avenue North Naples Florida 34102 —
Florida Cancer Specialists - North Region Research Office,4945 SW 49th Place Ocala Florida 34474 —
Florida Cancer Specialists - North Region Research Office,2824 Enterprise Rd Orange City Florida 32763 —
AdventHealth Medical Group,2501 North Orange Ave Orlando Florida 32804 —
Florida Cancer Specialists - North Region Research Office,70 W. Gore Street Orlando Florida 32806 —
Florida Cancer Specialists,22395 Edgewater Drive Port Charlotte Florida 33980 —
Florida Cancer Specialists,600 North Cattlemen Road Sarasota Florida 34232 —
Florida Cancer Specialists,1970 Golf Street Sarasota Florida 34236 —
Florida Cancer Specialists - North Region Research Office,7154 Medical Center Drive Spring Hill Florida 34608 —
Florida Cancer Specialists - North Region Research Office,1201 Fifth Avenue North St. Petersburg Florida 33705 —
Florida Cancer Specialists - North Region Research Office St. Petersburg Florida 33705 —
Florida Cancer Specialists - North Region Research Office,3402 West Dr. Martin Luther King Jr. Boulevard Tampa Florida 33607 —
Florida Cancer Specialists - North Region Research Office,4100 Waterman Way Tavares Florida 32778 —
Florida Cancer Specialists - North Region Research Office,1400 US Highway 441 N The Villages Florida 32159 —
Florida Cancer Specialists - North Region Research Office,9320 State Road 54 Trinity Florida 34655 —
Florida Cancer Specialists,901 South Tamiami Trail Venice Florida 34285 —
Florida Cancer Specialists,836 Sunset Lake Blvd Venice Florida 34292 —
Florida Cancer Specialists - North Region Research Office,460 N Orlando Ave Winter Park Florida 32789 —
Northside Hospital,125 King Avenue Athens Georgia 30606 —
Northside Hospital,5670 Peachtree Dunwoody Rd. Atlanta Georgia 30342 —
Northside Hospital Atlanta Georgia 30342 —
Northside Hospital,308 Deep South Farm Rd, Suite 200 Blairsville Georgia 30512 —
Northside Hospital,228 Riverstone Dr. Canton Georgia 30114 —
Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,157 Clinic Avenue Carrollton Georgia 30117 —
Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,100 Market Place Blvd Cartersville Georgia 30121 —
Northside Hospital,1505 Northside Blvd, Suite 4600 Cumming Georgia 30041 —
Northside Hospital,3855 Pleasant Hill Rd., Suite 480 Duluth Georgia 30096 —
Northside Hospital,308 Coliseum Dr. Macon Georgia 31217 —
Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC Marietta Georgia 30060 —
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago Illinois 60611 —
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1 Kish Hospital Drive DeKalb Illinois 60115 —
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,10 Health Services Drive DeKalb Illinois 60115 —
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,300 Randall Road Geneva Illinois 60134 —
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,304 Randall Road Geneva Illinois 60134 —
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1000 N. Westmoreland Road Lake Forest Illinois 60045 —
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4405 Weaver Parkway Warrenville Illinois 25731 —
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4455 Weaver Parkway Warrenville Illinois 60555 —
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,25 N Winfield Road Winfield Illinois 60190 —
University of Iowa Hospitals and Clinics Iowa City Iowa 52242 —
Norton Cancer Institute - Saint Matthews,234 E. Gray Strret Louisville Kentucky 40202 —
Norton Cancer Institute - Saint Matthews,676 S. Floyd Street Louisville Kentucky 40202 —
Norton Cancer Institute - Saint Matthews Louisville Kentucky 40207 —
Norton Cancer Institute - Saint Matthews,4955 Norton Healthcare Blvd Louisville Kentucky 40241 —
Cancer Institute Ascension Saint Agnes Baltimore Maryland 21229 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Dana-Farber Cancer Institute Boston Massachusetts 02215 —
The West Clinic, PLLC dba West Cancer Center,7668 Airways Blvd Southaven Mississippi 38671 —
New York Cancer & Blood Specialists - Port Jeffers,72 East Main St. Babylon New York 11702 —
New York Cancer & Blood Specialists - Port Jeffers,1 Delaware Dr. New Hyde Park New York 11042 —
New York Cancer & Blood Specialists - Port Jeffers,365 East Main St. Patchogue New York 11772 —
New York Cancer & Blood Specialists - Port Jeffers,1500 Rte, 112, Building 4 Port Jefferson New York 11776 —
New York Cancer & Blood Specialists - Port Jeffers,49 Rte. 347, Newconset Hwy Port Jefferson Station New York 11776 —
New York Cancer & Blood Specialists - Port Jeffers Port Jefferson Station New York 11776 —
New York Cancer & Blood Specialists - Port Jeffers,750 Old County Rd. Suite 4 Riverhead New York 11901 —
New York Cancer & Blood Specialists - Port Jeffers,12 East 86th St, Suite 4 The Bronx New York 10028 —
New York Cancer & Blood Specialists - Port Jeffers,2330 Eastchester Road, Suite 360 The Bronx New York 10469 —
Novant Health Cancer Institute - Forsyth,125 Queens Road, Suite 650 Charlotte North Carolina 28204 —
Novant Health Cancer Institute - Forsyth,2131 S. 17th Street Wilmington North Carolina 28401 —
Novant Health Cancer Institute - Forsyth Winston-Salem North Carolina 27103 —
Magee-Womens Hospital of UPMC,2500 West 12th Street Erie Pennsylvania 16505 —
Magee-Womens Hospital of UPMC,201 State Street, 6 Main Erie Pennsylvania 16550 —
Magee-Womens Hospital of UPMC,4300 Londonberry Road Harrisburg Pennsylvania 17109 —
Magee-Womens Hospital of UPMC,2035 Technology Parkway Mechanicsburg Pennsylvania 17050 —
University of Pennsylvania Abramson Cancer Center Philadelphia Pennsylvania 19104 —
Magee-Womens Hospital of UPMC Pittsburgh Pennsylvania 15213 —
Magee-Womens Hospital of UPMC,5115 Centre Avenue Pittsburgh Pennsylvania 15232 —
Magee-Womens Hospital of UPMC,1703 Innovation Drive York Pennsylvania 17408 —
Tennessee Oncology, PLLC,103 Natchez Park Drive Dickson Tennessee 37055 —
Tennessee Oncology, PLLC,4488 Carothers Parkway Franklin Tennessee 37067 —
Tennessee Oncology, PLLC,225 Big Station Camp Blvd Gallatin Tennessee 37066 —
The West Clinic, PLLC dba West Cancer Center Germantown Tennessee 38138 —
Tennessee Oncology, PLLC,353 New Shackle Island Road Hendersonville Tennessee 37075 —
Tennessee Oncology, PLLC,5653 First Blvd. Hermitage Tennessee 37076 —
Tennessee Oncology, PLLC,103 Physicians Way Lebanon Tennessee 37090 —
Tennessee Oncology, PLLC,1840 Medical Center Parkway Murfreesboro Tennessee 37129 —
Tennessee Oncology, PLLC,2004 Hayes Street Nashville Tennessee 37203 —
Tennessee Oncology, PLLC,SCRI Oncology Partners Nashville Tennessee 37203 —
Tennessee Oncology, PLLC Nashville Tennessee 37203 —
Tennessee Oncology, PLLC,4220 Harding Rd Nashville Tennessee 37205 —
Tennessee Oncology, PLLC,3443 Dickerson Road Nashville Tennessee 37207 —
Tennessee Oncology, PLLC,397 Wallace Road Nashville Tennessee 37211 —
Tennessee Oncology, PLLC,120 Frank Martin Road Shelbyville Tennessee 37160 —
Tennessee Oncology, PLLC,300 Stonecrest Blvd Smyrna Tennessee 37167 —
Texas Oncology PA,901 West 38th Street Austin Texas 78705 —
Texas Oncology PA Austin Texas 78731 —
Texas Oncology PA,4101 James Casey, Suite 100 Austin Texas 78745 —
Virginia Oncology Associates,744 N. Battlefield Blvd Chesapeake Virginia 23320 —
Virginia Oncology Associates,1051 Loftis Blvd Suite 100 Newport News Virginia 23606 —
Virginia Oncology Associates Norfolk Virginia 23502 —
Virginia Oncology Associates,1950 Glenn Mitchell Drive Virginia Beach Virginia 23456 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 233 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05382299, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 6, 2026 · Synced Nov 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05382299 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →