<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/NCT04460898</url>
  </required_header>
  <id_info>
    <org_study_id>A5481123</org_study_id>
    <nct_id>NCT04460898</nct_id>
  </id_info>
  <brief_title>RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.</brief_title>
  <official_title>Real-World Treatment Patterns and Outcomes in Postmenopausal, Hormone-Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative, Metastatic Breast Cancer Patients Treated With Palbociclib Plus an Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.</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 treatment patterns and&#xD;
      clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received&#xD;
      Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology&#xD;
      network settings.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2019</start_date>
  <completion_date type="Actual">June 24, 2019</completion_date>
  <primary_completion_date type="Actual">June 24, 2019</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>Progression Free Survival (PFS)</measure>
    <time_frame>mBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor response</measure>
    <time_frame>mBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients receiving various cancer treatment regimens</measure>
    <time_frame>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>mBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients receiving each starting dose and end dose for those on palbociclib combination therapy</measure>
    <time_frame>mBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients that experienced dose adjustment</measure>
    <time_frame>mBC diagnosis through end of study (assessed up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients that discontinued therapy</measure>
    <time_frame>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">195</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Breast Cancer Patients</arm_group_label>
    <description>HR+/HER2- metastatic breast cancer patients in the US.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include adult patients aged 18 years and older, diagnosed with HR+/HER2- mBC&#xD;
        and received treatment with Palbociclib in combination with letrozole as initial&#xD;
        endocrine-therapy for advanced/metastatic breast cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must meet all of the following inclusion criteria to be eligible for&#xD;
             inclusion in the study:&#xD;
&#xD;
               1. Diagnosed with locoregional recurrent or metastatic female breast cancer.&#xD;
&#xD;
               2. Pathologically confirmed HR-positive/HER2-negative diagnosis.&#xD;
&#xD;
               3. Received treatment with palbociclib in combination with letrozole as initial&#xD;
                  endocrine-based therapy for advanced/metastatic breast cancer:&#xD;
&#xD;
                    1. Initiated treatment with palbociclib at least 3 months following the&#xD;
                       provider's first use of palbociclib following its FDA approval.&#xD;
&#xD;
                    2. At least 1 month of follow-up (at least one visit with the provider) after&#xD;
                       initiation of palbociclib.&#xD;
&#xD;
               4. Postmenopausal (or receiving surgical or medical treatment to induce menopause)&#xD;
                  at the time of initiation of palbociclib.&#xD;
&#xD;
               5. ≥18 year old at initiation of palbociclib.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria will be imposed for the selection of patients.&#xD;
      </textblock>
    </criteria>
    <gender>Female</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=A5481123</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>April 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>April 9, 2022</last_update_submitted>
  <last_update_submitted_qc>April 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 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>May 24, 2022</submitted>
    <returned>February 24, 2023</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/NCT04460898
org study id: A5481123
nct id: NCT04460898
lead sponsor: 
This is a retrospective, observational study that will document treatment patterns and
      clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received
      Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology
      network settings.
observational model: Cohort
time perspective: Retrospective
measure: Progression Free Survival (PFS)
time frame: mBC diagnosis through end of study (assessed up to 24 months)
measure: Tumor response
time frame: mBC diagnosis through end of study (assessed up to 24 months)
measure: Proportion of patients receiving various cancer treatment regimens
time frame: mBC diagnosis through end of study (assessed up to 24 months)
measure: Proportion of patients receiving each therapy sequence across lines
time frame: mBC diagnosis through end of study (assessed up to 24 months)
measure: Proportion of patients receiving each starting dose and end dose for those on palbociclib combination therapy
time frame: mBC diagnosis through end of study (assessed up to 24 months)
measure: Proportion of patients that experienced dose adjustment
time frame: mBC diagnosis through end of study (assessed up to 24 months)
measure: Proportion of patients that discontinued therapy
time frame: mBC diagnosis through end of study (assessed up to 24 months)
arm group label: Breast Cancer Patients
description: HR+/HER2- metastatic breast cancer patients in the US.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
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=A5481123
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: May 24, 2022
returned: February 24, 2023