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Clinical Trials in the UK / NCT05382299
Active, not recruiting Phase 3

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

NCT05382299 · tracked via the Priya Life Science UK tracker
Sponsor
Gilead Sciences
Phase
Phase 3
Started
2022-07-20
Last updated
2026-04-06

Condition(s) studied

Triple Negative Breast CancerPD-L1 Negative

Investigational drug(s) / intervention(s)

Sacituzumab Govitecan-hziyPaclitaxelnab-PaclitaxelGemcitabineCarboplatin

Sacituzumab Govitecan-hziy: Administered intravenously

Paclitaxel: Administered intravenously

nab-Paclitaxel: Administered intravenously

Gemcitabine: Administered intravenously

Carboplatin: Administered intravenously

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC) * Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity * Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue * Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence * Individuals presenting with de novo metastatic TNBC are eligible * Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Demonstrates adequate organ function * Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception * Individuals with human immunodeficiency virus (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 systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment * Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry * 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 * Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor * Active second malignancy * Active serious infection requiring antibiotics * Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (363)

FacilityCityRegionStatus
Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd Tucson Arizona
Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd. Tucson Arizona
Arizona Oncology Associates, PC-Hope Tucson Arizona
Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road Tucson Arizona
University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200 Burbank California
University of California San Diego Moores Cancer La Jolla California
University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200 Laguna Hills California
University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240 San Luis Obispo California
University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600 Santa Monica California
University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304 Santa Monica California
University of California Los Angeles - Jonsson Comprehensive Cancer Center Santa Monica California
Torrance Memorial Physician Network - Cancer Care Torrance California
University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100 Westlake Village California
Rocky Mountain Cancer Centers,1700 South Potomac Street Aurora Colorado
Rocky Mountain Cancer Centers Boulder Colorado
Rocky Mountain Cancer Centers,2312 N. Nevada Avenue Colorado Springs Colorado
Rocky Mountain Cancer Centers,6031 E. Woodman Rd. Colorado Springs Colorado
Rocky Mountain Cancer Centers,4700 E. Hale Parkway Denver Colorado
Rocky Mountain Cancer Centers,11750 West 2nd Place Lakewood Colorado
Rocky Mountain Cancer Centers,22 West Dry Creek Circle Littleton Colorado
Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway Lone Tree Colorado
Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210 Longmont Colorado
Rocky Mountain Cancer Centers,3676 Parker Blvd Pueblo Colorado
Rocky Mountain Cancer Centers,525 W. 15th Street Pueblo Colorado
Rocky Mountain Cancer Centers,8820 Huron Street Thornton Colorado
AdventHealth Medical Group Altamonte Springs Florida
Florida Cancer Specialists - North Region Research Office,750 Orienta Ave Altamonte Springs Florida
Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 A Bonita Springs Florida
Florida Cancer Specialists,3630 Manatee Avenue West Bradenton Florida
Florida Cancer Specialists,5985 Silver Falls Run Bradenton Florida
Florida Cancer Specialists - North Region Research Office,403 S. Kings Ave. Brandon Florida
Florida Cancer Specialists,1030 Commerce Creek Blvd Cape Coral Florida
Florida Cancer Specialists - North Region Research Office,3280 McMullen Booth Road Clearwater Florida
Florida Cancer Specialists Fort Myers Florida
Florida Cancer Specialists,8981 Colonial Center Drive Fort Myers Florida
Florida Cancer Specialists,8260 Gladiolus Dr Fort Myers Florida
Florida Cancer Specialists - North Region Research Office,6420 W. Newberry Road Gainesville Florida
Florida Cancer Specialists - North Region Research Office,100 Highland Avenue Largo Florida
Florida Cancer Specialists - North Region Research Office,521 North Lecanto Highway Lecanto Florida
Florida Cancer Specialists,1100 Goodlette Road Naples Florida

+ 323 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05382299 on ClinicalTrials.gov ↗ ← All trials in the UK