Korea Post Marketing Surveillance (PMS) Study of Talzenna®

NCT04982848 | Not Yet Recruiting FDA Drug

• 2 other identifiers: C3441038Talzenna PMS
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms

Keywords

gBRCA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  through study completion, an expected average of 8 months

Study Arms (1)

Talzenna treated group

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

Drug: Talzenna

Interventions

Talzenna DRUG

Talzenna treatment under Korea regulatory approval indication/dosage

Talzenna treated group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Talzenna® is indicated as monotherapy for the treatment of adult patients with breast cancer susceptibility gene (BRCA) mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or advanced setting.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

talazoparib

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 29, 2021
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share