Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Costa Mesa, California and other locations
Dates
study started
completion around

Description

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).

Official Title

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

Keywords

Triple Negative Breast Cancer, PD-L1 Positive, Breast Neoplasms, Triple Negative Breast Neoplasms, Paclitaxel, Albumin-Bound Paclitaxel, Carboplatin, Gemcitabine, Pembrolizumab, Sacituzumab govitecan, Sacituzumab Govitecan-hziy, nab-Paclitaxel, Sacituzumab Govitecan-hziy (SG) + Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California Irvine Health Chao Family,1640 Newport Blvd accepting new patients
    Costa Mesa California 92627 United States
  • University of California Irvine Health Chao Family accepting new patients
    Orange California 92868 United States
  • City of Hope,1601 Avocado Ave accepting new patients
    Newport California 92660 United States
  • Cancer and Blood Specialty Clinic accepting new patients
    Los Alamitos California 90720 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT05382286
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 440 study participants
Last Updated