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Clinical Trials in the UK / NCT05382286
Active, not recruiting Phase 3

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

NCT05382286 · tracked via the Priya Life Science UK tracker
Sponsor
Gilead Sciences
Phase
Phase 3
Started
2022-07-25
Last updated
2025-09-18

Condition(s) studied

Triple Negative Breast CancerPD-L1 Positive

Investigational drug(s) / intervention(s)

Sacituzumab Govitecan-hziyPembrolizumabPaclitaxelnab-PaclitaxelGemcitabineCarboplatin

Sacituzumab Govitecan-hziy: Administered intravenously

Pembrolizumab: 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) 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (504)

FacilityCityRegionStatus
Alaska Oncology and Hematology Anchorage Alaska
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
Genesis Cancer and Blood Institute Hot Springs Arkansas
Genesis Cancer and Blood Institute,1456 Higdon Ferry Road Suite B. Hot Springs Arkansas
Saint Bernards Medical Center Jonesboro Arkansas
Saint Bernards Medical Center,4000 Linwood Drive Paragould Arkansas
University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200 Burbank California
University of California Irvine Health Chao Family,1640 Newport Blvd Costa Mesa California
City of Hope Duarte 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
Cancer and Blood Specialty Clinic Los Alamitos California
City of Hope,1601 Avocado Ave Newport California
University of California Irvine Health Chao Family Orange California
City of Hope,209 Fair Oaks Ave Pasadena California
University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240 San Luis Obispo California
Sansum Clinic Santa Barbara 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
St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare Santa Rosa California
Sansum Clinic,2040 Viborg Road Solvang California
City of Hope,5215 Torrance Blvd Torrance California
Torrance Memorial Physician Network - Cancer Care Torrance California
City of Hope,1100 San Bernardino Rd Upland 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

+ 464 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Gilead Sciences trials in the UK

Other trials for the same condition

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 NCT05382286 on ClinicalTrials.gov ↗ ← All trials in the UK