Trials / Not Yet Recruiting
Not Yet RecruitingNCT04982848
Korea Post Marketing Surveillance (PMS) Study of Talzenna®
A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Talzenna(Registered)
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Talzenna | Talzenna treatment under Korea regulatory approval indication/dosage |
Timeline
- Start date
- 2027-06-01
- Primary completion
- 2028-11-01
- Completion
- 2028-11-01
- First posted
- 2021-07-29
- Last updated
- 2025-11-18
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04982848. Inclusion in this directory is not an endorsement.