Patterns of Prescribing and Monitoring of Palbociclib

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.

Study Overview

• Status: Completed
• Conditions: Advanced Breast Cancer; Metastatic Breast Cancer; Estrogen Receptor-positive Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
• Intervention / Treatment: Drug: Palbociclib

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 Type: Observational
• Enrollment (Actual): 67

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients seen at RUMC

Description

Inclusion Criteria:

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

Exclusion Criteria:

• brain metastases
• on palbociclib clinical trial

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Palbociclib; women at least 18 years old, with ER+, HER2- advanced breast cancer, and were receiving palbociclib	Drug: Palbociclib; Observe patients receiving palbociclib for dose adjustment and lab monitoring; Other Names: IBRANCE

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Kathryn Schultz, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2015
• Primary Completion (Actual): December 30, 2016
• Study Completion (Actual): December 30, 2016

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Palbociclib
• Other Study ID Numbers: 16082509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No