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Patterns of Prescribing and Monitoring of Palbociclib

NCT03285568 — Completed, 67 participants, Rush University Medical Center
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RegistryNCT03285568
StatusCompleted
Study typeObservational
Enrollment67 (Actual)
SponsorRush University Medical Center (Other)
ConditionsMetastatic Breast Cancer, Advanced Breast Cancer, Estrogen Receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
InterventionsPalbociclib (Drug)
Datesstart 2015-02-03, primary completion 2016-12-30, completion 2016-12-30, first posted 2017-09-18, last updated 2023-03-31

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
PalbociclibDrug: Palbociclibwomen at least 18 years old, with ER+, HER2- advanced breast cancer, and were receiving palbociclib
  • Palbociclib (Drug), also known as IBRANCE: Observe patients receiving palbociclib for dose adjustment and lab monitoring

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to 50 Years

Inclusion Criteria:

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

Exclusion Criteria:

* brain metastases
* on palbociclib clinical trial

+Investigators

My Notes