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| ID | Type | Description | Link |
|---|---|---|---|
| SIRI | Other Identifier | Alias Study Number |
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The main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in Swedish clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR+/HER2- locally advanced or MBC in combination with an aromatase inhibitor (AI) | Group Description: patients with at least one filled prescription of palbociclib (ATC (anatomic therapeutic chemical classification system ) code: L01XE33) |
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| HR+/HER2- locally advanced or MBC cancer in combination with fulvestrant | Group Description: patients with at least one filled prescription of palbociclib ATC (code: L01XE33) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palbociclib | Drug | patients on palbociclib combination treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients on treatment | Proportion of patients who have not discontinued treatment will be assessed at various timepoints (Time Frame: treatment start date through end of study [assessed up to 48 months]) | 01 January 2017 until 30 September 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients alive | Proportion of patients alive on palbociclib combination treatment at different points in time (Time Frame: treatment start date through end of study [assessed up to 48 months]) | 01 January 2017 until 30 September 2020 |
| Describe the demographic and clinical characteristics of the patient population receiving palbociclib combination treatment |
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Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Exclusion Criteria:
There are no exclusion criteria
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The study population will include all adult (age ≥18 years) patients (male and female) with at least one filled prescription of palbociclib (ATC code: L01XE33) registered in the Swedish Prescribed Drug Register between January 1st, 2017 and June 30th 2020.
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Sweden | Recruiting | Sollentuna | Sweden |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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 |
|---|---|
| C500026 | palbociclib |
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| 01 January 2017 until 30 September 2020 |
| D017437 |
| Skin and Connective Tissue Diseases |