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| ID | Type | Description | Link |
|---|---|---|---|
| Talzenna PMS | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Talzenna treated group | Talzenna treated gBRCA Breast cancer patients in the real world setting in Korea |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talzenna | Drug | Talzenna treatment under Korea regulatory approval indication/dosage |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overal response (Effectiveness outcome) by Response Evaluation Criteria In Solid Tumors (RECIST) critera | It is non-interventional, observational study in the real world setting. Response evaluation will be assessed based on the real world clinical practice | through study completion, an expected average of 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C586365 | talazoparib |
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| D017437 |
| Skin and Connective Tissue Diseases |