Trials / Completed
CompletedNCT03285568
Patterns of Prescribing and Monitoring of Palbociclib
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 67 (actual)
- Sponsor
- Rush University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Metastatic Breast Cancer
- Advanced Breast Cancer
- Estrogen Receptor-positive Breast Cancer
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Palbociclib | Observe patients receiving palbociclib for dose adjustment and lab monitoring |
Timeline
- Start date
- 2015-02-03
- Primary completion
- 2016-12-30
- Completion
- 2016-12-30
- First posted
- 2017-09-18
- Last updated
- 2023-03-31
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03285568. Inclusion in this directory is not an endorsement.