NCT03285568

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

September 14, 2017

Last Update Submit

March 28, 2023

Conditions

Metastatic Breast CancerAdvanced Breast CancerEstrogen Receptor-positive Breast CancerHuman Epidermal Growth Factor 2 Negative Carcinoma of Breast

Outcome Measures

Primary Outcomes (1)

  • 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.

    22 months

Secondary Outcomes (5)

  • Dose adjustment for hematologic toxicities

    22 months

  • Number of patients who experienced neutropenia.

    22 months

  • Duration of therapy

    22 months

  • Progression free survival (PFS)

    22 months

  • Adherence to manufacturer monitoring recommendations

    22 months

Study Arms (1)

Palbociclib

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

Drug: Palbociclib

Interventions

PalbociclibDRUG

Observe patients receiving palbociclib for dose adjustment and lab monitoring

Also known as: IBRANCE
Palbociclib

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailswomen at least 18 years old with - ER+, HER2- advanced breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients seen at RUMC

You may qualify if:

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

You may not qualify if:

  • brain metastases
  • on palbociclib clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kathryn Schultz

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

February 3, 2015

Primary Completion

December 30, 2016

Study Completion

December 30, 2016

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share