Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03989089 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhasePhase 2
Started
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Apr 1, 2023 to Dec 1, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 1, 2023 to Dec 1, 2026
    • Site details revised at 2 of 2 sites
    v6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2019 to Jul 3, 2020
    • Study sites: 1 to 2
    v5
  3. Collaborators revised (3)v4
  4. Re-verified, no change to tracked fieldsv3
  5. Secondary endpoints revised (3)
    • Study description revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03989089
Lead Sponsor University of Malaya
Collaborators: Merck Sharp & Dohme LLC, National University Hospital, Singapore, Cancer Research Malaysia
Conditions
(from sponsor)		 HER2-Negative Breast Cancer
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov