Korea Post Marketing Surveillance (PMS) Study of Talzenna®

Pfizer

Status: Begins enrollment in a year or more

Conditions: Breast Neoplasms

Treatments: Drug: Talzenna

Study type: Observational

Funder types: Industry

Identifiers

NCT04982848

Talzenna PMS (Other Identifier)

C3441038

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 1 patient group

Talzenna treated group

Description:

Talzenna treated gBRCA Breast cancer patients in the real world setting in Korea

Treatment:

Drug: Talzenna