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Bortezomib Followed by Pembrolizumab and Cisplatin in metTNBC

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Mar 31, 2026 to Mar 31, 2027
    v10
  2. Primary completion date: Oct 1, 2024 to Dec 31, 2025
    • Study completion date: Dec 1, 2024 to Mar 31, 2026
    v9
  3. Primary completion date: Oct 1, 2023 to Oct 1, 2024
    • Study completion date: Dec 1, 2023 to Dec 1, 2024
    v8
  4. 3 versions Re-verified since Oct 7, 2021, no change to tracked fieldsv5-v7
  5. Primary completion date: Sep 1, 2021 to Oct 1, 2023
    • Study completion date: Sep 1, 2021 to Dec 1, 2023
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2020 to Oct 15, 2020
    • Eligibility criteria expanded, about 26 words
    • Site details revised
    v3
  2. Start date: Mar 1, 2020 to May 1, 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The hypothesis of this pilot trial is that administration of bortezomib will inhibit NHEJ in metastatic TNBC leading at the time of disease progression to metastases that are HR-deficient and sensitive to pembrolizumab and cisplatin therapy. The trial will include in depth analysis of the patients' TNBC genome and phosphoproteome to evaluate HR-proficiency and deficiency, and nuclear proteins that drive NHEJ, before and upon progression with bortezomib therapy.
Trial Details
NCT Number NCT04265872
Lead Sponsor Baylor Research Institute
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov