drugset / Trial / NCT05128734
Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaparib | Small molecule | 200 mg | Oral |
| Subject | Temozolomide | Small molecule | 50 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 75 mg/m2 | Oral |