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NOT YET RECRUITING
NCT05128734
PHASE2

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

Sponsor: AHS Cancer Control Alberta

View on ClinicalTrials.gov

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).

Official title: A Randomized Phase II Study of Temozolomide Monotherapy or in Combination With Olaparib in Patients With METHYLATED 06-Methylguanine-DNA Methyltransferase (MGMT) Pre-Treated Triple Negative Breast Cancer (TNBC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-04-01

Completion Date

2028-07-01

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DRUG

Temozolomide

Temozolomidewill be administered orally for 7 days (D) every 21 days until progression of the disease in both arms.

DRUG

Olaparib

Olaparib will be administered orally twice daily in treatment arm 2.

Locations (1)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada