Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Why stopped (as posted): Withdrawal of the marketing authorization for the breast cancer indication of Talzenna® in Korea, not related to safety concerns or any regulatory authority request
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Talzenna | Drug | Talazoparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Talzenna treated group
- description
- Talzenna treated gBRCA Breast cancer patients in the real world setting in Korea
- interventionNames
- Drug: Talzenna
Primary outcomes (1)
- measure
- Incidence of adverse events categorized according to physical organ and disease/symptom
- timeFrame
- From date of randomization until the 28 calendar days following the last administration of a drug under study
- description
- It is non-interventional, observational study in the real world setting. Adverse events will be captured in the real world clinical practice.
Secondary outcomes (1)
- measure
- Overal response (Effectiveness outcome) by Response Evaluation Criteria In Solid Tumors (RECIST) critera
- timeFrame
- through study completion, an expected average of 8 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
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