Patterns of Prescribing and Monitoring of Palbociclib

Metastatic Breast Cancer Clinical Trial

Official title:

Patterns of Prescribing and Monitoring of Palbociclib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285568
• Other study ID #: 16082509
• Status: Completed
• Start date: February 3, 2015
• Est. completion date: December 30, 2016

Study information

• Verified date: March 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 30, 2016
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• women at least 18 years old

• ER+, HER2- advanced breast cancer

• receiving palbociclib

Exclusion Criteria:

• brain metastases

• on palbociclib clinical trial

Related Conditions & MeSH terms

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

Intervention

Drug:
• Palbociclib
Observe patients receiving palbociclib for dose adjustment and lab monitoring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dose adjustment for hematologic toxicities	Number of patients who required dose adjustment for hematologic toxicities while on the study.	22 months
Secondary	Number of patients who experienced neutropenia.	Patients who experienced neutropenia as a result of their participation in the study.	22 months
Secondary	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
Secondary	Progression free survival (PFS)	Progression free survival duration of patients that were in the study who received Palbociclib	22 months
Secondary	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