drugset / Trial / NCT05128734

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

NCT05128734

Phase 2 Not yet recruiting 40 enrolled AHS Cancer Control Alberta
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2026-04-01
Primary completion
2028-04-01
Completion
2028-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule 200 mg Oral
Subject Temozolomide Small molecule 50 mg/m2 Oral
Subject Temozolomide Small molecule 75 mg/m2 Oral