Korea Post Marketing Surveillance (PMS) Study of Talzenna®

Launched by PFIZER · Jul 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of Talzenna®, a medication designed to treat advanced breast cancer in patients with a specific genetic condition known as gBRCA. The purpose of the study is to monitor the effectiveness and safety of Talzenna once it is made available in Korea. This is important because it helps to identify any potential issues that might arise when people start using the medication in everyday medical practice.

To be eligible for this study, patients must be planning to start treatment with Talzenna as recommended by their doctor and must provide written consent to participate. However, individuals with known allergies to Talzenna or its ingredients, those who are breastfeeding, or anyone who does not agree to let Pfizer use their personal information cannot participate. As the study is not yet recruiting, patients can expect to be contacted later if they meet the criteria, and they will receive detailed information about what participation involves.

Gender

ALL

Eligibility criteria

• 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.