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NCT04982848 | NOT YET RECRUITING | Breast Neoplasms

Korea Post Marketing Surveillance (PMS) Study of Talzenna®
Sponsor:

Pfizer

Brief Summary:

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.

Condition or disease

Breast Neoplasms

Intervention/treatment

Talzenna

Study Type : OBSERVATIONAL
Estimated Enrollment : 600 participants
Official Title : A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Talzenna(Registered)
Actual Study Start Date : 2025-12-31
Estimated Primary Completion Date : 2026-11-30
Estimated Study Completion Date : 2026-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Patient scheduled to start treatment with Talzenna® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (local label)
  • 2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria
  • 1. Patients with known hypersensitivity to Talzenna®, or to any of the excipients.
  • 2. Breastfeeding
  • 3. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
Korea Post Marketing Surveillance (PMS) Study of Talzenna®

Location Details

NCT04982848

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How to Participate

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