Korea Post Marketing Surveillance (PMS) Study of Talzenna®
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Talzenna.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Talzenna(Registered)
Overview
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.
Interventions
- Drug Talzenna
Talzenna treatment under Korea regulatory approval indication/dosage
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Overal response (Effectiveness outcome) by Response Evaluation Criteria In Solid Tumors (RECIST) critera [Time frame: through study completion, an expected average of 8 months]
Eligibility criteria
Inclusion criteria
- 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)
- 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
- Patients with known hypersensitivity to Talzenna®, or to any of the excipients.
- Breastfeeding
- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04982848 · C3441038 · Talzenna PMS