Korea Post Marketing Surveillance (PMS) Study of Talzenna®
NCT04982848 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600
Last updated 2025-11-18
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.
Conditions
- Breast Neoplasms
Interventions
- DRUG
-
Talzenna
Talzenna treatment under Korea regulatory approval indication/dosage
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2027-06-01
- Primary Completion
- 2028-11-01
- Completion
- 2028-11-01
- FDA Drug
- Yes
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