Patterns of Prescribing and Monitoring of Palbociclib
Sponsor
Rush University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03285568
Collaborator
(none)
67
22.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
67 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Patterns of Prescribing and Monitoring of Palbociclib
Actual Study Start Date
:
Feb 3, 2015
Actual Primary Completion Date
:
Dec 30, 2016
Actual Study Completion Date
:
Dec 30, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Palbociclib 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
|
Outcome Measures
Primary Outcome Measures
- identify the proportion of patients who were maintained on a palbociclib dose according to the package insert recommendations [2/3/2015-12/30/2016]
Secondary Outcome Measures
- number of patients who required dose adjustment for hematologic toxicities [2/3/2015-12/30/2016]
- number of patients who experienced neutropenia [2/3/2015-12/30/2016]
- duration of therapy [2/3/2015-12/30/2016]
- progression free survival (PFS) [2/3/2015-12/30/2016]
- percent adherence to manufacturer monitoring recommendations [2/3/2015-12/30/2016]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Rush University Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT03285568
Other Study ID Numbers:
- 16082509
First Posted:
Sep 18, 2017
Last Update Posted:
Oct 25, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: