<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/NCT04498481</url>
  </required_header>
  <id_info>
    <org_study_id>A5481095</org_study_id>
    <nct_id>NCT04498481</nct_id>
  </id_info>
  <brief_title>TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATION TREATMENT (WITH AI OR FULVESTRANT) FOR HR+/HER2- A/MBC IN A COMMUNITY ONCOLOGY SETTING.</brief_title>
  <official_title>TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB PLUS AROMATASE INHIBITOR OR PALBOCICLIB PLUS FULVESTRANT AS TREATMENT OF HORMONE RECEPTOR POSITIVE (HR+)/HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HER2-) ADVANCED OR METASTATIC BREAST CANCER IN A REAL WORLD 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>
      This is a retrospective, observational study that will document the treatment and monitoring&#xD;
      patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received&#xD;
      Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC&#xD;
      community oncology setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</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>Proportion of patients receiving various cancer treatment regimens</measure>
    <time_frame>A/MBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients receiving each therapy sequence across lines</measure>
    <time_frame>A/MBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment persistence</measure>
    <time_frame>A/MBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>A/MBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>A/MBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor response rate</measure>
    <time_frame>A/MBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients that experience dose adjustment</measure>
    <time_frame>A/MBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients who discontinue therapy</measure>
    <time_frame>A/MBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Breast cancer patients</arm_group_label>
    <description>HR+/HER2- advanced/metastatic breast cancer patients in the USA.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include adult patients aged 18 years and older, diagnosed with HR+/HER2-&#xD;
        a/mBC who received Palbociclib combination therapy with AI or fulvestrant on or after&#xD;
        2/3/2015.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who are represented in the Vector Oncology Data Warehouse who meet all of the&#xD;
        following criteria will be eligible for inclusion in the study.&#xD;
&#xD;
          -  Female.&#xD;
&#xD;
          -  Diagnosis of female breast cancer with evidence of metastatic disease or advanced&#xD;
             disease.&#xD;
&#xD;
          -  Diagnosis (confirmed by clinical review) of advanced or metastatic breast cancer at&#xD;
             any time, defined as breast cancer at stage IIIb, stage IIIc, or stage IV or&#xD;
             identified as having distant metastasis.&#xD;
&#xD;
          -  Indication in the record of ER or PR positive disease, or absence of any indication of&#xD;
             ER and PR negative disease (ie, patients are eligible without affirmative indication&#xD;
             of ER/PR+ status as long as ER/PR- indication is not present).&#xD;
&#xD;
          -  Receipt of a palbociclib plus aromatase inhibitor (AI) or palbociclib plus fulvestrant&#xD;
             regimen on 2/3/2015 or later in the advanced and metastatic setting. Data collection&#xD;
             will prioritize accrual of patients with 1L use of palbociclib plus AI and with 2L use&#xD;
             of palbociclib plus fulvestrant before collecting other use of palbociclib users.&#xD;
&#xD;
          -  Age greater than or equal to 18 years at A/MBC diagnosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -There are no exclusion criteria for this study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</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=A5481095</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</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 25, 2021</submitted>
    <returned>April 23, 2021</returned>
    <submitted>November 29, 2021</submitted>
    <returned>February 9, 2022</returned>
    <submitted>March 2, 2022</submitted>
    <returned>May 19, 2022</returned>
  </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/NCT04498481
org study id: A5481095
nct id: NCT04498481
lead sponsor: 
This is a retrospective, observational study that will document the treatment and monitoring
      patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received
      Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC
      community oncology setting.
observational model: Cohort
time perspective: Retrospective
measure: Proportion of patients receiving various cancer treatment regimens
time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Proportion of patients receiving each therapy sequence across lines
time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Treatment persistence
time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Progression Free Survival (PFS)
time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Overall Survival (OS)
time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Tumor response rate
time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Proportion of patients that experience dose adjustment
time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Proportion of patients who discontinue therapy
time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
arm group label: Breast cancer patients
description: HR+/HER2- advanced/metastatic breast cancer patients in the USA.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
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=A5481095
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 25, 2021
returned: April 23, 2021
submitted: November 29, 2021
returned: February 9, 2022
submitted: March 2, 2022
returned: May 19, 2022