Clinical Trial

Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)

Not Yet Recruiting Phase 2
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Summary
This is a randomized phase II study to evaluate the disease control rate (DCR) of patients with metastatic or locally advanced METHYLATED 06-methylguanine-DNA methyltransferase (MGMT) with triple-negative breast cancer (TNBC) treated with Temozolomide ± Olaparib. Patients will be randomized 1:1 to Treatment Arm 1 (temozolomide treatment) or Arm 2 (temozolomide plus olaparib treatment).
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2021-11-17; most recent amendment 2025-12-08.
Trial Details
NCT Number NCT05128734
Lead Sponsor AHS Cancer Control Alberta
Conditions Breast Cancer Triple Negative
Enrollment 40 participants
Start Date 2026-04-01
Primary Completion 2028-04-01 (estimated)
Study Completion 2028-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-15