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Korea Post Marketing Surveillance (PMS) Study of Talzenna®
Sponsor: Pfizer
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.
Official title: A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Talzenna(Registered)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
OBSERVATIONAL
Enrollment
600
Start Date
2027-06-01
Completion Date
2028-11-01
Last Updated
2025-11-18
Healthy Volunteers
No
Conditions
Interventions
Talzenna
Talzenna treatment under Korea regulatory approval indication/dosage