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 study on Breast Cancer Triple-Negative Breast Cancer PD-L1 Positive
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Burbank, California and other locations
- Dates
- study startedcompletion 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 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 - City of Hope,5215 Torrance Blvd
accepting new patients
Torrance California 90503 United States - City of Hope,209 Fair Oaks Ave
accepting new patients
Pasadena California 91030 United States - Torrance Memorial Physician Network - Cancer Care
accepting new patients
Torrance California 90505 United States - City of Hope
accepting new patients
Duarte California 91010 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Gilead Sciences
- Links
- Gilead Clinical Trials Website Sign up for this study
- ID
- NCT05382286
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 440 study participants
- Last Updated
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