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TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Start date: Apr 17, 2019 to Apr 19, 2019v17
  2. Notable Primary and study completion dates: Mar 2026 to Apr 2027v16
  3. Notable Primary and study completion dates: Mar 2025 to Mar 2026v15
  4. Minor Primary and study completion dates: Dec 2024 to Mar 2025v14
  5. Notable Primary and study completion dates: Mar 2024 to Dec 2024v13
Show 11 earlier versionsHide 11 earlier versions
  1. Minor Primary and study completion dates: Dec 31, 2023 to Mar 2024v12
  2. Notable Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023 Primary endpoint revised · Secondary endpoint revisedv11 Show 2 more changesShow less
    • Primary endpoint revised
    • Secondary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Trial status: Recruiting to Active, Not Recruiting Study sites: 3 to 2v10 Show 1 more changeShow less
    • Study sites: 3 to 2
  4. Notable Primary completion date: Dec 31, 2021 to Dec 31, 2022 Eligibility criteria expanded, about 8 words · Site details revised at 2 of 3 sitesv9 Show 2 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Site details revised at 2 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Minor Re-verified, no change to tracked fieldsv8
  6. Notable Primary completion date: Dec 31, 2020 to Dec 31, 2021 Study sites: 2 to 3 · Completion date: Dec 31, 2021 to Dec 31, 2022 · Eligibility criteria expanded, about 616 wordsv7 Show 3 more changesShow less
    • Study sites: 2 to 3
    • Completion date: Dec 31, 2021 to Dec 31, 2022
    • Eligibility criteria expanded, about 616 words

    See this version in full on ClinicalTrials.gov ↗

  7. Minor Site contacts updated at 1 of 2 sitesv6
  8. Minor Re-verified, no change to tracked fieldsv5
  9. Notable Primary completion date: May 1, 2020 to Dec 31, 2020 Completion date: May 1, 2021 to Dec 31, 2021v4 Show 1 more changeShow less
    • Completion date: May 1, 2021 to Dec 31, 2021
  10. Minor Study sites: 1 to 2v3
  11. Notable Primary endpoint revised Secondary endpoint revisedv2 Show 1 more changeShow less
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multi-institutional pilot trial for patients with advanced breast cancer. The trial is designed to assess the safety and tolerability of induction talazoparib followed by combination of talazoparib and avelumab. As an exploratory endpoint, the study team will evaluate the immunomodulatory effects of induction talazoparib followed by the combination of talazoparib and avelumab in patients with advanced breast cancer.
Trial Details
NCT Number NCT03964532
Lead Sponsor Georgetown University
Collaborators: Pfizer
Conditions Breast Cancer
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov