Clinical Trial

Comprehensive Analysis of Predictors of the Treatment With Pembrolizumab and Olaparib in Patients With Unresectable or Metastatic HER2 Negative Breast Cancer and a Deleterious Germline Mutation or a Homologous Recombination Deficiency (COMPRENDO

Study acronym: COMPRENDO
Active, Not Recruiting Phase 2
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Record status
This record was last updated May 7, 2024 (before its estimated January 2025 completion). Its status may not reflect the trial's current state.
Summary
This study will examine the combination of pembrolizumab and olaparib in three populations. * Cohort 1: aBC patients with a germline mutation in BRCA1 or BRCA2, * cohort 2: aBC patients with a germline mutation in one of the moderate penetrance homologous repair genes (ATM, BARD1, CHEK2, FANCC, PALB2, RAD51C, RAD51D, SLX4, XRCC2), and * cohort 3: aBC patients with a HRD as assessed by whole genome sequencing.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-08-30; most recent amendment 2025-10-17.
Status change: Active, Not Recruiting → Completed 2025-10-17
Status change: Recruiting → Active, Not Recruiting 2024-05-06
Status change: Not Yet Recruiting → Recruiting 2023-02-20
Trial Details
NCT Number NCT05033756
Lead Sponsor Institut fuer Frauengesundheit
Collaborators: Merck Sharp & Dohme LLC
Conditions Malignant Neoplasm of Breast, Breast Cancer
Enrollment 11 participants
Start Date 2022-07-30
Primary Completion 2025-01 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2024-05-07