Patterns of Prescribing and Monitoring of Palbociclib

Completed

• Conditions: Estrogen Receptor-positive Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Metastatic Breast Cancer; Advanced Breast Cancer
• Interventions: Drug: Palbociclib

• Registration Number: NCT03285568
• Lead Sponsor: Rush University Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-02-03
• Primary Completion: 2016-12-30
• Study Completion: 2016-12-30
• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-18
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• women at least 18 years old
• ER+, HER2- advanced breast cancer
• receiving palbociclib

Exclusion Criteria

• brain metastases
• on palbociclib clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Palbociclib	Palbociclib	women at least 18 years old, with ER+, HER2- advanced breast cancer, and were receiving palbociclib

Primary Outcome Measures

Name	Time	Method
Palbociclib dose according to the package insert recommendations.	22 months	Identify the proportion of patients who were maintained on a palbociclib dose according to the package insert recommendations.

Secondary Outcome Measures

Name	Time	Method
Dose adjustment for hematologic toxicities	22 months	Number of patients who required dose adjustment for hematologic toxicities while on the study.
Number of patients who experienced neutropenia.	22 months	Patients who experienced neutropenia as a result of their participation in the study.
Duration of therapy	22 months	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
Progression free survival (PFS)	22 months	Progression free survival duration of patients that were in the study who received Palbociclib
Adherence to manufacturer monitoring recommendations	22 months	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.