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

NCT04982848

Not Yet RecruitingN/A

Sponsor: Pfizer

Conditions: Breast Neoplasms

Interventions: Talzenna

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.

Eligibility overview

Sex: ALL

Age: 19 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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.