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Korea Post Marketing Surveillance (PMS) Study of Talzenna®

StatusWithdrawn
PhaseNot specified
SponsorPfizer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Withdrawn before enrolling Sponsor's reason: Withdrawal of the marketing authorization for the breast cancer indication of Talzenna® in Korea, not related to safety concerns or any regulatory authority request
    • Enrollment target: estimated 600 to confirmed 0
    v14
  2. Primary and study completion dates: Oct 31, 2026 to Nov 1, 2028
    • Start date: Dec 31, 2025 to Jun 1, 2027
    v13
  3. 3 versions Re-verified since Jun 10, 2025, no change to tracked fieldsv10-v12
  4. Primary and study completion dates: Nov 30, 2026 to Oct 31, 2026v9
  5. Start date: Dec 31, 2024 to Dec 31, 2025v8
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Jun 1, 2024 to Dec 31, 2024v7
  2. Re-verified, no change to tracked fieldsv6
  3. Start date: May 2024 to Jun 1, 2024v5
  4. Start date: Aug 31, 2022 to May 2024v4
  5. Start date: Jul 1, 2022 to Aug 31, 2022
    • Primary completion date: Jun 30, 2026 to Nov 30, 2026
    v3
  6. Start date: Oct 1, 2021 to Jul 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Pfizer
436 trials monitored
See 32 trials at risk
Breast Cancer
5,418 trials monitored
See 296 trials at risk
Talzenna will be approved for the treatment of gBRCA advanced breast cancer in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Talzenna after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Talzenna will be observed.
Trial Details
NCT Number NCT04982848
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Breast Neoplasms
Related terms Breast Neoplasms
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov