Korea Post Marketing Surveillance (PMS) Study of Talzenna®

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.

Why the study stopped: Withdrawal of the marketing authorization for the breast cancer indication of Talzenna® in Korea, not related to safety concerns or any regulatory authority request

Withdrawn

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Talzenna

Drug

Talzenna treatment under Korea regulatory approval indication/dosage

Primary outcomes

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

It is non-interventional, observational study in the real world setting. Adverse events will be captured in the real world clinical practice.

Secondary outcomes

Overal response (Effectiveness outcome) by Response Evaluation Criteria In Solid Tumors (RECIST) critera

Time frame: 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PROSPECTIVE, SINGLE-ARM, OPEN-LABEL, NON-INTERVENTIONAL, MULTI-CENTRE, POST MARKETING SURVEILLANCE (PMS) STUDY OF TALZENNA(REGISTERED)

Important dates

Study start: 2027
Primary completion: 2028
Study completion: 2028
First posted: Jul 29, 2021
Registry last updated: Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Withdrawn