MedTrace Logo

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

NCT05128734 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-15

No results posted yet for this study

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).

Conditions

  • Breast Cancer Triple Negative

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.

Sponsors & Collaborators

  • AHS Cancer Control Alberta

    lead OTHER

Principal Investigators

  • Don Morris, MD, PhD · Arthur J.E. Child Comprehensive Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05128734 on ClinicalTrials.gov