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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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

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

NCT05382286•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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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.

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

Key Dates

Start Date

July 25, 2022

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2027

Last Updated

September 18, 2025

Enrollment

443

ACTUAL participants

Conditions

Triple Negative Breast CancerPD-L1 Positive

Interventions

Sacituzumab Govitecan-hziy

DRUG

Pembrolizumab

DRUG

Paclitaxel

DRUG

nab-Paclitaxel

DRUG

Gemcitabine

DRUG

Carboplatin

DRUG

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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RECRUITINGPHASE1/PHASE2

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

NCT04585750

Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

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