<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03285568</url>
  </required_header>
  <id_info>
    <org_study_id>16082509</org_study_id>
    <nct_id>NCT03285568</nct_id>
  </id_info>
  <brief_title>Patterns of Prescribing and Monitoring of Palbociclib</brief_title>
  <official_title>Patterns of Prescribing and Monitoring of Palbociclib</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if patients with ER+, human epidermal growth factor&#xD;
      2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring&#xD;
      based on manufacturer recommendations at a tertiary academic medical center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a retrospective, single-center study that included women receiving palbociclib&#xD;
      for the treatment of ER+, HER2- advanced breast cancer. Exclusion criteria were the presence&#xD;
      of brain metastases or active enrollment in a palbociclib clinical trial.&#xD;
&#xD;
      The primary endpoint was the proportion of patients who were maintained on a palbociclib dose&#xD;
      according to the adjustment schedule in package insert recommendations.&#xD;
&#xD;
      The secondary endpoints were the number of patients dose adjusted for hematologic toxicities,&#xD;
      the number of patients experiencing neutropenia, duration of therapy, progression-free&#xD;
      survival (PFS), and adherence to manufacturer monitoring recommendations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2015</start_date>
  <completion_date type="Actual">December 30, 2016</completion_date>
  <primary_completion_date type="Actual">December 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Palbociclib dose according to the package insert recommendations.</measure>
    <time_frame>22 months</time_frame>
    <description>Identify the proportion of patients who were maintained on a palbociclib dose according to the package insert recommendations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dose adjustment for hematologic toxicities</measure>
    <time_frame>22 months</time_frame>
    <description>Number of patients who required dose adjustment for hematologic toxicities while on the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who experienced neutropenia.</measure>
    <time_frame>22 months</time_frame>
    <description>Patients who experienced neutropenia as a result of their participation in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of therapy</measure>
    <time_frame>22 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>22 months</time_frame>
    <description>Progression free survival duration of patients that were in the study who received Palbociclib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to manufacturer monitoring recommendations</measure>
    <time_frame>22 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">67</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <condition>Advanced Breast Cancer</condition>
  <condition>Estrogen Receptor-positive Breast Cancer</condition>
  <condition>Human Epidermal Growth Factor 2 Negative Carcinoma of Breast</condition>
  <arm_group>
    <arm_group_label>Palbociclib</arm_group_label>
    <description>women at least 18 years old, with ER+, HER2- advanced breast cancer, and were receiving palbociclib</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Palbociclib</intervention_name>
    <description>Observe patients receiving palbociclib for dose adjustment and lab monitoring</description>
    <arm_group_label>Palbociclib</arm_group_label>
    <other_name>IBRANCE</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients seen at RUMC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women at least 18 years old&#xD;
&#xD;
          -  ER+, HER2- advanced breast cancer&#xD;
&#xD;
          -  receiving palbociclib&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  brain metastases&#xD;
&#xD;
          -  on palbociclib clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>women at least 18 years old with - ER+, HER2- advanced breast cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn Schultz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Palbociclib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03285568
org study id: 16082509
nct id: NCT03285568
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
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.
observational model: Cohort
time perspective: Retrospective
measure: Palbociclib dose according to the package insert recommendations.
time frame: 22 months
description: Identify the proportion of patients who were maintained on a palbociclib dose according to the package insert recommendations.
measure: Dose adjustment for hematologic toxicities
time frame: 22 months
description: Number of patients who required dose adjustment for hematologic toxicities while on the study.
measure: Number of patients who experienced neutropenia.
time frame: 22 months
description: Patients who experienced neutropenia as a result of their participation in the study.
measure: Duration of therapy
time frame: 22 months
description: 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
measure: Progression free survival (PFS)
time frame: 22 months
description: Progression free survival duration of patients that were in the study who received Palbociclib
measure: Adherence to manufacturer monitoring recommendations
time frame: 22 months
description: 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.
arm group label: Palbociclib
description: women at least 18 years old, with ER+, HER2- advanced breast cancer, and were receiving palbociclib
intervention type: Drug
intervention name: Palbociclib
description: Observe patients receiving palbociclib for dose adjustment and lab monitoring
arm group label: Palbociclib
other name: IBRANCE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: women at least 18 years old with - ER+, HER2- advanced breast cancer
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Kathryn Schultz
role: Principal Investigator
affiliation: Rush University Medical Center
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Palbociclib
sharing ipd: No