Korea Post Marketing Surveillance (PMS) Study of Talzenna®

Not yet recruiting

• Conditions: Breast Neoplasms
• Interventions: Drug: Talzenna

• Registration Number: NCT04982848
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2021-07-14
• Study First Submitted QC: 2021-07-23
• Study First Posted: 2021-07-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23
• Study Start: 2024-12-31
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Talzenna treated group	Talzenna	Talzenna treated gBRCA Breast cancer patients in the real world setting in Korea

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events categorized according to physical organ and disease/symptom	From date of randomization until the 28 calendar days following the last administration of a drug under study	It is non-interventional, observational study in the real world setting. Adverse events will be captured in the real world clinical practice.

Secondary Outcome Measures

Name	Time	Method
Overal response (Effectiveness outcome) by Response Evaluation Criteria In Solid Tumors (RECIST) critera	through study completion, an expected average of 8 months	It is non-interventional, observational study in the real world setting. Response evaluation will be assessed based on the real world clinical practice