Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

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

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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
  • 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 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

You CAN'T join if...

  • 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.

Locations

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200 accepting new patients
    Burbank California 91505 United States
  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200 accepting new patients
    Laguna Hills California 91505 United States
  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600 accepting new patients
    Santa Monica California 90404 United States
  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304 accepting new patients
    Santa Monica California 90404 United States
  • University of California Los Angeles - Jonsson Comprehensive Cancer Center accepting new patients
    Santa Monica California 90404 United States
  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100 accepting new patients
    Westlake Village California 91361 United States
  • Cancer and Blood Specialty Clinic accepting new patients
    Los Alamitos California 90720 United States
  • Torrance Memorial Physician Network - Cancer Care accepting new patients
    Torrance California 90505 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT05382299
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 540 study participants
Last Updated