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OpenTrials
Completed

NCT Number: NCT03285568

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.

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Key information

Conditions

Metastatic Breast Cancer Advanced Breast Cancer Breast Diseases Breast Neoplasms Estrogen Receptor-positive Breast Cancer Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • brain metastases
  • on palbociclib clinical trial

Treatment and study plan

Palbociclib

Drug

Observe patients receiving palbociclib for dose adjustment and lab monitoring

Other names: IBRANCE

Primary outcomes

  1. Palbociclib dose according to the package insert recommendations.

    Time frame: 22 months

    Identify the proportion of patients who were maintained on a palbociclib dose according to the package insert recommendations.

Secondary outcomes

  1. Dose adjustment for hematologic toxicities

    Time frame: 22 months

    Number of patients who required dose adjustment for hematologic toxicities while on the study.

  2. Number of patients who experienced neutropenia.

    Time frame: 22 months

    Patients who experienced neutropenia as a result of their participation in the study.

  3. Duration of therapy

    Time frame: 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

  4. Progression free survival (PFS)

    Time frame: 22 months

    Progression free survival duration of patients that were in the study who received Palbociclib

  5. Adherence to manufacturer monitoring recommendations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2017
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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