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The purpose of this real-world study is to look at breast cancer patients receiving Palbociclib using a large real-world database collected under real-world practice. This study also looks at the safety of Ibrance, including any side effects. Side effects are undesired effects of a medicine or other type of treatment.
This study will include the data of the following participants:
This study will look at the safety of palbociclib treatment by looking at the number and severity of the side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrance (palbociclib) | Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrance | Drug | Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events that occur during treatment | From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023 | |
| Number of participants with associated risk factors | From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From baseline to the date of death or censoring date, whichever occurs first on participants diagnosed between 29 Aug 2015 through 30 Sep 2023 | |
| Real-World Tumor Response (rwTR) | From baseline to the date of death or censoring date, whichever occurs first on participants diagnosed between 29 Aug 2015 through 30 Sep 2023 |
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Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Adult women (≥ 18 years of age) with at least one visit with a breast cancer ICD10 diagnosis code (C50.x)
Patients with locally advanced breast cancer or metastatic breast cancer with a staging classification of stage III, stage IV (distant metastases).
Patients with a laboratory test positive for hormone receptor (HR) and negative for human epithelial growth factor receptor 2 (HER2) before or up to 60 days after advanced/metastatic breast cancer diagnosis date.
Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer
Exclusion Criteria
Patients meeting any of the following criteria will not be included in the study:
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Study participants will be patients diagnosed with HR(+)/HER2(-) advanced/metastatic breast cancer between August 29, 2015 and September 30, 2023 who meet the general prescribing criteria for Palbociclib in South Korea according to the national product manual, and who meet the following inclusion and exclusion criteria, as determined by data from one year prior to the Ibrance approval date
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer New York | New York | New York | 10001 | United States |
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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 |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C500026 | palbociclib |
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