Breast Neoplasms Clinical Trial
Official title:
A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Talzenna(Registered)
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.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | November 30, 2026 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events categorized according to physical organ and disease/symptom | It is non-interventional, observational study in the real world setting. Adverse events will be captured in the real world clinical practice. | From date of randomization until the 28 calendar days following the last administration of a drug under study | |
Secondary | Overal response (Effectiveness outcome) by Response Evaluation Criteria In Solid Tumors (RECIST) critera | It is non-interventional, observational study in the real world setting. Response evaluation will be assessed based on the real world clinical practice | through study completion, an expected average of 8 months |
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