Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Triple Negative Breast Cancer
PD-L1 Positive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 pembrol...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
July 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2027
Estimated Enrollment :
443 Patients enrolled
Trial Details
Trial ID
NCT05382286
Start Date
July 25 2022
End Date
February 1 2027
Last Update
September 18 2025
Active Locations (504)
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1
Alaska Oncology and Hematology
Anchorage, Alaska, United States, 99508
2
Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd
Tucson, Arizona, United States, 85704
3
Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd.
Tucson, Arizona, United States, 85704
4
Arizona Oncology Associates, PC-Hope
Tucson, Arizona, United States, 85711