<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/NCT04460911</url>
  </required_header>
  <id_info>
    <org_study_id>A5481128</org_study_id>
    <secondary_id>US oncology</secondary_id>
    <nct_id>NCT04460911</nct_id>
  </id_info>
  <brief_title>Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.</brief_title>
  <official_title>Treatment Patterns And Clinical Outcomes Among Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (mBC) Receiving Palbociclib in Combination With Fulvestrant (PB+FUL) In The US Community Oncology Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <brief_summary>
    <textblock>
      By leveraging a community-based, cancer-specific electronic healthcare record for this study,&#xD;
      we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2-&#xD;
      mBC who received care within the context of a large community oncology network in the United&#xD;
      States.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 19, 2019</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</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>Baseline Demographic Characteristic of Participants</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline Clinical Characteristics of Participants</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dosing strength distribution of advanced mBC</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Treatment (DOT) of advanced mBC</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with Prior adjuvant treatment of advanced mBC</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Year of treatment initiation of advanced mBC</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients with dosing changes</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to chemotherapy</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for treatment discontinuation</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Real-world duration of therapy (rwDOT)</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to next treatment (TTNT)</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider-documented progression</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Real-world time to progression (rwTTP)</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Real-world progression-free survival (rwPFS)</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Treatment initiation through end of study (Assessed up to 60 months)</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">317</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>PAL + FUL</arm_group_label>
    <description>Patients who initiated palbociclib-fulvestrant combination therapy as first-line or beyond therapy in the advanced or metastatic setting.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative&#xD;
        Metastatic Breast Cancer (mBC) Receiving Palbociclib Combination Therapy, Endocrine&#xD;
        Monotherapy Or Fulvestrant Monotherapy In The US Community Oncology Setting&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Documented diagnosis of HR+/HER2- mBC&#xD;
&#xD;
          2. Initiated palbociclib + fulvestrant as first-line therapy in the metastatic setting&#xD;
             and had at least 2 visits following the index date&#xD;
&#xD;
          3. Received care at a US oncology site(s) utilizing the full EHR at time of treatment and&#xD;
             data are available for research purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Enrollment in an interventional clinical trial during the study period&#xD;
&#xD;
          2. Evidence of prior treatment with CDK4/6 inhibitors in the metastatic setting&#xD;
&#xD;
          3. Receipt of treatment indicated for another primary cancer during the study period or&#xD;
             history of another primary cancer documented within the US Oncology EHR.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pfizer United States</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=A5481128</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>December 5, 2022</last_update_submitted>
  <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>March 30, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04460911
org study id: A5481128
secondary id: US oncology
nct id: NCT04460911
lead sponsor: 
By leveraging a community-based, cancer-specific electronic healthcare record for this study,
      we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2-
      mBC who received care within the context of a large community oncology network in the United
      States.
observational model: Cohort
time perspective: Retrospective
measure: Baseline Demographic Characteristic of Participants
time frame: Baseline
measure: Baseline Clinical Characteristics of Participants
time frame: Baseline
measure: Dosing strength distribution of advanced mBC
time frame: Treatment initiation through end of study (Assessed up to 60 months)
measure: Duration of Treatment (DOT) of advanced mBC
time frame: Treatment initiation through end of study (Assessed up to 60 months)
measure: Number of patients with Prior adjuvant treatment of advanced mBC
time frame: Treatment initiation through end of study (Assessed up to 60 months)
measure: Year of treatment initiation of advanced mBC
time frame: Treatment initiation through end of study (Assessed up to 60 months)
measure: Percentage of patients with dosing changes
time frame: Treatment initiation through end of study (Assessed up to 60 months)
measure: Time to chemotherapy
time frame: Treatment initiation through end of study (Assessed up to 60 months)
measure: Reasons for treatment discontinuation
time frame: Treatment initiation through end of study (Assessed up to 60 months)
measure: Real-world duration of therapy (rwDOT)
time frame: Treatment initiation through end of study (Assessed up to 60 months)
measure: Time to next treatment (TTNT)
time frame: Treatment initiation through end of study (Assessed up to 60 months)
measure: Provider-documented progression
time frame: Treatment initiation through end of study (Assessed up to 60 months)
measure: Real-world time to progression (rwTTP)
time frame: Treatment initiation through end of study (Assessed up to 60 months)
measure: Real-world progression-free survival (rwPFS)
time frame: Treatment initiation through end of study (Assessed up to 60 months)
measure: Overall survival (OS)
time frame: Treatment initiation through end of study (Assessed up to 60 months)
arm group label: PAL + FUL
description: Patients who initiated palbociclib-fulvestrant combination therapy as first-line or beyond therapy in the advanced or metastatic setting.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=A5481128
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
submitted: March 30, 2023