Korea Post Marketing Surveillance (PMS) Study of Talzenna®

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04982848

Enrollment

Registered

2021-07-29

Start date

2027-06-01

Completion date

2028-11-01

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

gBRCA

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.

Interventions

DRUGTalzenna

Talzenna treatment under Korea regulatory approval indication/dosage

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026