Clinical Trial

Study of Pembrolizumab in Metastatic HER2-negative Breast Cancer Patients With APOBEC3B Mutation

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated December 18, 2024 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is an open label investigator initiated Phase II study of single agent pembrolizumab (Keytruda) in metastatic HER2-receptive negative breast cancer patients with germline deletion in the cytosine deaminase (APOBEC3B) gene. Approximately 44 subjects from Malaysia and Singapore will be enrolled in this study to examine the efficacy of pembrolizumab when given 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations (2 years). This study will be conducted in conformance with Good Clinical Practices. Specific procedures to be performed during the trial, as well as their prescribed times and associated visit windows, are outlined in the Trial Flow Chart.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2019-06-17; most recent amendment 2024-12-13.
Status change: Recruiting → Active, Not Recruiting 2024-12-13
Status change: Not Yet Recruiting → Recruiting 2020-07-19
Trial Details
NCT Number NCT03989089
Lead Sponsor University of Malaya
Collaborators: Merck Sharp & Dohme LLC, National University Hospital, Singapore, Cancer Research Malaysia
Conditions HER2-Negative Breast Cancer
Enrollment 44 participants
Start Date 2020-07-03
Primary Completion 2025-12-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-18