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

Sponsor
AHS Cancer Control Alberta
Study ID
NCT05128734
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer Triple Negative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Temozolomide — DRUG
    Temozolomidewill be administered orally for 7 days (D) every 21 days until progression of the disease in both arms.
  • Olaparib — DRUG
    Olaparib will be administered orally twice daily in treatment arm 2.

Study Details

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).

Key Dates

Start date
Apr 1, 2026
Status verified
Dec 2025
Primary completion
Apr 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Temozolomide Arm
    Temozolomide: 50 mg/m2 daily in cycles of 21 days
  • Experimental: Temozolomide+Olaparib Arm
    Temozolomide 75 mg/m2 day 1 to day 7 with Olaparib 200 mg BID, oral, day 1 to day 7 in cycles of 21 days

Primary Outcome Measure

Disease Control Rate (DCR) [ Time Frame: From the date of first study drug dosing to the date of first documented complete response or partial response or stable disease, whichever came first, assessed up to 5 years. ]

Central Contacts

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