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Korea Post Marketing Surveillance (PMS) Study of Talzenna®

Studies

Study First Submitted Date 2021-07-14
Study First Posted Date 2021-07-29
Last Update Posted Date 2023-06-01
Start Month Year June 1, 2024
Primary Completion Month Year November 30, 2026
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-06-01

Browse Interventions

Sequence: 96202352 Sequence: 96202353 Sequence: 96202354 Sequence: 96202355 Sequence: 96202356
Mesh Term Talazoparib Mesh Term Poly(ADP-ribose) Polymerase Inhibitors Mesh Term Enzyme Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Antineoplastic Agents
Downcase Mesh Term talazoparib Downcase Mesh Term poly(adp-ribose) polymerase inhibitors Downcase Mesh Term enzyme inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term antineoplastic agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52265185
Name Breast Neoplasms
Downcase Name breast neoplasms

Id Information

Sequence: 40226918 Sequence: 40226919
Id Source org_study_id Id Source secondary_id
Id Value C3441038 Id Value Talzenna PMS
Id Type Other Identifier
Id Type Description Alias Study Number

Design Groups

Sequence: 55698477
Title Talzenna treated group
Description Talzenna treated gBRCA Breast cancer patients in the real world setting in Korea

Interventions

Sequence: 52577863
Intervention Type Drug
Name Talzenna
Description Talzenna treatment under Korea regulatory approval indication/dosage

Keywords

Sequence: 80002567
Name gBRCA
Downcase Name gbrca

Design Outcomes

Sequence: 177724748 Sequence: 177724749
Outcome Type primary Outcome Type secondary
Measure Incidence of adverse events categorized according to physical organ and disease/symptom Measure Overal response (Effectiveness outcome) by Response Evaluation Criteria In Solid Tumors (RECIST) critera
Time Frame From date of randomization until the 28 calendar days following the last administration of a drug under study Time Frame through study completion, an expected average of 8 months
Description It is non-interventional, observational study in the real world setting. Adverse events will be captured in the real world clinical practice. Description It is non-interventional, observational study in the real world setting. Response evaluation will be assessed based on the real world clinical practice

Browse Conditions

Sequence: 193846248 Sequence: 193846249 Sequence: 193846250 Sequence: 193846251 Sequence: 193846252
Mesh Term Breast Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Breast Diseases Mesh Term Skin Diseases
Downcase Mesh Term breast neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term breast diseases Downcase Mesh Term skin diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48407017
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Pfizer

Overall Officials

Sequence: 29336294
Role Study Director
Name Pfizer CT.gov Call Center
Affiliation Pfizer

Central Contacts

Sequence: 12030998
Contact Type primary
Name Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Role Contact

Design Group Interventions

Sequence: 68276133
Design Group Id 55698477
Intervention Id 52577863

Eligibilities

Sequence: 30820067
Sampling Method Non-Probability Sample
Gender All
Minimum Age 19 Years
Maximum Age N/A
Healthy Volunteers No
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.
Criteria 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.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254104063
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 19
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30566014
Observational Model Case-Only
Time Perspective Prospective

Responsible Parties

Sequence: 28932409
Responsible Party Type Sponsor