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The purpose of this study is to determine if patients with ER+, human epidermal growth factor 2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring based on manufacturer recommendations at a tertiary academic medical center.
This study was a retrospective, single-center study that included women receiving palbociclib for the treatment of ER+, HER2- advanced breast cancer. Exclusion criteria were the presence of brain metastases or active enrollment in a palbociclib clinical trial.
The primary endpoint was the proportion of patients who were maintained on a palbociclib dose according to the adjustment schedule in package insert recommendations.
The secondary endpoints were the number of patients dose adjusted for hematologic toxicities, the number of patients experiencing neutropenia, duration of therapy, progression-free survival (PFS), and adherence to manufacturer monitoring recommendations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palbociclib | women at least 18 years old, with ER+, HER2- advanced breast cancer, and were receiving palbociclib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib | Drug | Observe patients receiving palbociclib for dose adjustment and lab monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Palbociclib dose according to the package insert recommendations. | Identify the proportion of patients who were maintained on a palbociclib dose according to the package insert recommendations. | 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dose adjustment for hematologic toxicities | Number of patients who required dose adjustment for hematologic toxicities while on the study. | 22 months |
| Number of patients who experienced neutropenia. |
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Inclusion Criteria:
Exclusion Criteria:
women at least 18 years old with - ER+, HER2- advanced breast cancer
All patients seen at RUMC
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Schultz | Rush University Medical Center | Principal Investigator |
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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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Patients who experienced neutropenia as a result of their participation in the study.
| 22 months |
| Duration of therapy | Number of patients who completed the study compared to the number of patients who were was discontinued with the most common reason for discontinuation being disease progression | 22 months |
| Progression free survival (PFS) | Progression free survival duration of patients that were in the study who received Palbociclib | 22 months |
| Adherence to manufacturer monitoring recommendations | Patient adherence was also a limitation of this study as providers relied on the patient report to track medication adherence. Insurance coverage and access to palbociclib also contributed some variability as there were occasional delays in initiation of therapy or change in dose. | 22 months |
| D017437 |
| Skin and Connective Tissue Diseases |