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
a study on Breast Cancer Triple-Negative Breast Cancer PD-L1 Negative
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Burbank 5331835, California 5332921 and other locations
- Dates
- study startedstudy ends around
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, Triple Negative Breast Neoplasms, sacituzumab govitecan, Paclitaxel, 130-nm albumin-bound paclitaxel, Albumin-Bound Paclitaxel, Gemcitabine, 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 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
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
Burbank 5331835 California 5332921 91505 United States - University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200
Laguna Hills 5364306 California 5332921 91505 United States - University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600
Santa Monica 5393212 California 5332921 90404 United States - University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304
Santa Monica 5393212 California 5332921 90404 United States - University of California Los Angeles - Jonsson Comprehensive Cancer Center
Santa Monica 5393212 California 5332921 90404 United States - University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100
Westlake Village 5408395 California 5332921 91361 United States - Torrance Memorial Physician Network - Cancer Care
Torrance 5403022 California 5332921 90505 United States
Details
- Status
- in progress, not 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
- About 623 people participating
- Last Updated