Patterns of Prescribing and Monitoring of Palbociclib

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Patterns of Prescribing and Monitoring of Palbociclib

Conditions
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Advanced Breast Cancer, Metastatic Breast Cancer, Estrogen Receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Intervention / Treatment
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* Drug: Palbociclib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women at least 18 years old ER+, HER2- advanced breast cancer receiving palbociclib Exclusion Criteria: brain metastases on palbociclib clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Palbociclib<br>women at least 18 years old, with ER+, HER2- advanced breast cancer, and were receiving palbociclib | Drug: Palbociclib<br>* Observe patients receiving palbociclib for dose adjustment and lab monitoring<br>* Other names: IBRANCE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |