Advanced Breast Cancer, Estrogen Receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Metastatic Breast Cancer
Conditions
Brief 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.
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.
Interventions
DRUGPalbociclib
Observe patients receiving palbociclib for dose adjustment and lab monitoring
Sponsors
Rush University Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* women at least 18 years old * ER+, HER2- advanced breast cancer * receiving palbociclib
Exclusion criteria
* brain metastases * on palbociclib clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed