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

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Jul 1, 2027 to Apr 1, 2028
    • Start date: Sep 1, 2025 to Apr 1, 2026
    v10
  2. Start date: Jan 1, 2025 to Sep 1, 2025
    • Study site revised
    v9
  3. Start date: Jul 1, 2024 to Jan 1, 2025v8
  4. Start date: Dec 1, 2023 to Jul 1, 2024
    • Primary completion date: Dec 1, 2027 to Jul 1, 2027
    • Site contact updated
    v7
  5. Study sites: 0 to 1v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Apr 1, 2027 to Dec 1, 2027
    • Start date: Apr 1, 2023 to Dec 1, 2023
    • Study completion date: Dec 1, 2027 to Jul 1, 2028
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Start date: Dec 1, 2022 to Apr 1, 2023v3
  4. Start date: Apr 1, 2022 to Dec 1, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05128734
Lead Sponsor AHS Cancer Control Alberta
Conditions
(from sponsor)		 Breast Cancer Triple Negative
Related terms Triple Negative Breast Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov