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| ID | Type | Description | Link |
|---|---|---|---|
| PALCAN | Other Identifier | Alias Study Number |
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The purpose of this real-world study is to understand the use of palbociclib as first treatment for Hormone receptor positive (HR+) and Human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in Canada (PALCAN).
The real-world study is not a research study. It involves real patients who receive medicines prescribed by their doctors in the real world. Metastatic breast cancer is the type which has spread from breast to other organs.
HR positive stands for Hormone-receptor cells that have a protein on their surface that binds to one of 2 types of hormones. They are estrogen or progesterone. Both these hormones help cancer cells grow.
HER2 negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to come back or spread to other parts of the body.
This study will mainly measure:
- duration of treatment (from start of treatment till end of treatment) among a group of patients taking palbociclib (Ibrance) in combination with hormone therapy as first line treatment for HR+ HER2- metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First-line patients on Palbociclib | Participants taking oral palbociclib as prescribed in first-line treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib | Drug | Participants taking oral palbociclib as prescribed in first-line treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the median Duration of Treatment (DoT) | Time index of approximately 01 Jan 2016 to 31 March 2022 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with treatment discontinuation at one-year intervals | Time index of approximately 01 Jan 2016 to 31 March 2022 | |
| Number of patients starting at initial dose | Time index of approximately 01 Jan 2016 to 31 March 2022 |
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Inclusion Criteria:
Exclusion Criteria:
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Treatment of Canadian women patients on palbociclib with HR+/HER2- metastatic breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Health Services | Edmonton | Alberta | Canada |
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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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| Time to chemotherapy | Time index of approximately 01 Jan 2016 to 31 March 2022 |
| Clinical Characteristics of Patients | Time index of approximately 01 Jan 2016 to 31 March 2022 |
| Demographical Characteristics of Patients | Time index of approximately 01 Jan 2016 to 31 March 2022 |
| D017437 |
| Skin and Connective Tissue Diseases |