Korea Post Marketing Surveillance (PMS) Study of Talzenna®

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04982848

Collaborator

(none)

600

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Drug: Talzenna

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 31, 2022

Anticipated Primary Completion Date :

Nov 30, 2026

Anticipated Study Completion Date :

Nov 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Talzenna treated group Talzenna treated gBRCA Breast cancer patients in the real world setting in Korea	Drug: Talzenna Talzenna treatment under Korea regulatory approval indication/dosage

Arm

Intervention/Treatment

Talzenna treated group

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

Drug: Talzenna

Talzenna treatment under Korea regulatory approval indication/dosage

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT04982848

Other Study ID Numbers:

C3441038
Talzenna PMS

First Posted:

Jul 29, 2021

Last Update Posted:

Aug 2, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pfizer

gBRCA

Additional relevant MeSH terms:

Breast Neoplasms

Talazoparib

Study Results

No Results Posted as of Aug 2, 2022