Korea Post Marketing Surveillance (PMS) Study of Talzenna®

Sponsor
Pfizer
Study ID
NCT04982848
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Talzenna — DRUG
    Talzenna treatment under Korea regulatory approval indication/dosage

Study Details

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.

Key Dates

First listed
Jul 29, 2021
Start date
Jun 1, 2027
Status verified
Nov 2025
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Talzenna treated group
    Talzenna treated gBRCA Breast cancer patients in the real world setting in Korea

Primary Outcome Measure

Incidence of adverse events categorized according to physical organ and disease/symptom [ Time Frame: From date of randomization until the 28 calendar days following the last administration of a drug under study ]

Central Contacts

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