Korea Post Marketing Surveillance (PMS) Study of Talzenna®

Breast Neoplasms Clinical Trial

Official title:

A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Talzenna(Registered)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04982848
• Other study ID #: C3441038
• Secondary ID: Talzenna PMS
• Status: Not yet recruiting
• Start date: December 31, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Talzenna
Talzenna treatment under Korea regulatory approval indication/dosage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

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