An observational study in Metastatic Breast Cancer, Advanced Breast Cancer and Estrogen Receptor-positive Breast Cancer, sponsored by Rush University Medical Center. Completed. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by Rush University Medical Center · Observational
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.
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.
All patients seen at RUMC
Exclusion Criteria:
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
Also known as: IBRANCE
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.
Time frame: 22 months
Dose adjustment for hematologic toxicities
Number of patients who required dose adjustment for hematologic toxicities while on the study.
Time frame: 22 months
Number of patients who experienced neutropenia.
Patients who experienced neutropenia as a result of their participation in the study.
Time frame: 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
Time frame: 22 months
Progression free survival (PFS)
Progression free survival duration of patients that were in the study who received Palbociclib
Time frame: 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.
Time frame: 22 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Rush University Medical Center