xml: <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/NCT06003114</url>
    </required_header>
    <id_info>
      <org_study_id>A5481183</org_study_id>
      <secondary_id>PALCAN</secondary_id>
      <nct_id>NCT06003114</nct_id>
    </id_info>
    <brief_title>A Study to Understand the Use of Palbociclib in Canadian Patients With Breast Cancer That Has Spread to Other Organs</brief_title>
    <official_title>Real-World Utilization of Palbociclib as 1L Treatment in Canadian HR+/HER2-women Breast Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pfizer</source>
    <brief_summary>
      <textblock>
        The purpose of this real-world study is to understand the use of palbociclib as first&#xD;
        treatment for Hormone receptor positive (HR+) and Human epidermal growth factor receptor 2&#xD;
        negative (HER2-) metastatic breast cancer in Canada (PALCAN).&#xD;
  &#xD;
        The real-world study is not a research study. It involves real patients who receive medicines&#xD;
        prescribed by their doctors in the real world. Metastatic breast cancer is the type which has&#xD;
        spread from breast to other organs.&#xD;
  &#xD;
        HR positive stands for Hormone-receptor cells that have a protein on their surface that binds&#xD;
        to one of 2 types of hormones. They are estrogen or progesterone. Both these hormones help&#xD;
        cancer cells grow.&#xD;
  &#xD;
        HER2 negative describes cells that have a small amount or none of a protein called HER2 on&#xD;
        their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2&#xD;
        negative may grow more slowly and are less likely to come back or spread to other parts of&#xD;
        the body.&#xD;
  &#xD;
        This study will mainly measure:&#xD;
  &#xD;
        - duration of treatment (from start of treatment till end of treatment) among a group of&#xD;
        patients taking palbociclib (Ibrance) in combination with hormone therapy as first line&#xD;
        treatment for HR+ HER2- metastatic breast cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 8, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Estimate the median Duration of Treatment (DoT)</measure>
      <time_frame>Time index of approximately 01 Jan 2016 to 31 March 2022</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of patients with treatment discontinuation at one-year intervals</measure>
      <time_frame>Time index of approximately 01 Jan 2016 to 31 March 2022</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients starting at initial dose</measure>
      <time_frame>Time index of approximately 01 Jan 2016 to 31 March 2022</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to chemotherapy</measure>
      <time_frame>Time index of approximately 01 Jan 2016 to 31 March 2022</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Characteristics of Patients</measure>
      <time_frame>Time index of approximately 01 Jan 2016 to 31 March 2022</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Demographical Characteristics of Patients</measure>
      <time_frame>Time index of approximately 01 Jan 2016 to 31 March 2022</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>First-line patients on Palbociclib</arm_group_label>
      <description>Participants taking oral palbociclib as prescribed in first-line treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Palbociclib</intervention_name>
      <description>Participants taking oral palbociclib as prescribed in first-line treatment.</description>
      <arm_group_label>First-line patients on Palbociclib</arm_group_label>
      <other_name>Ibrance</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Treatment of Canadian women patients on palbociclib with HR+/HER2- metastatic breast cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Received at least one cycle of palbociclib as first line therapy for metastatic breast&#xD;
               cancer between 01 January 2016 and 31 December 2022&#xD;
  &#xD;
            -  Histologically confirmed HR+/HER2- metastatic breast cancer&#xD;
  &#xD;
            -  Minimum of 3 months available follow-up on palbociclib&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Received a different CDK4/6 inhibitor before palbociclib in the first line&#xD;
  &#xD;
            -  Received other systemic therapy, including hormone therapy, 15-60 days prior to&#xD;
               initiation of palbociclib&#xD;
  &#xD;
            -  Invalid or incomplete records (more specifically, complete duration of treatment on&#xD;
               palbociclib, endocrine therapy or LHRH)&#xD;
  &#xD;
            -  Death date recorded on or before the date of index date&#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>
    <overall_contact>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Metastatic breast cancer (MBC)</keyword>
    <keyword>Human epidermal growth factor receptor 2 negative (HER2-)</keyword>
    <keyword>Hormone receptor positive (HR+)</keyword>
    <keyword>First line</keyword>
    <keyword>Real world</keyword>
    <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>
      <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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06003114
  org study id: A5481183
  secondary id: PALCAN
  nct id: NCT06003114
  lead sponsor: 
  The purpose of this real-world study is to understand the use of palbociclib as first
        treatment for Hormone receptor positive (HR+) and Human epidermal growth factor receptor 2
        negative (HER2-) metastatic breast cancer in Canada (PALCAN).
  
        The real-world study is not a research study. It involves real patients who receive medicines
        prescribed by their doctors in the real world. Metastatic breast cancer is the type which has
        spread from breast to other organs.
  
        HR positive stands for Hormone-receptor cells that have a protein on their surface that binds
        to one of 2 types of hormones. They are estrogen or progesterone. Both these hormones help
        cancer cells grow.
  
        HER2 negative describes cells that have a small amount or none of a protein called HER2 on
        their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2
        negative may grow more slowly and are less likely to come back or spread to other parts of
        the body.
  
        This study will mainly measure:
  
        - duration of treatment (from start of treatment till end of treatment) among a group of
        patients taking palbociclib (Ibrance) in combination with hormone therapy as first line
        treatment for HR+ HER2- metastatic breast cancer.
  observational model: Other
  time perspective: Retrospective
  measure: Estimate the median Duration of Treatment (DoT)
  time frame: Time index of approximately 01 Jan 2016 to 31 March 2022
  measure: Number of patients with treatment discontinuation at one-year intervals
  time frame: Time index of approximately 01 Jan 2016 to 31 March 2022
  measure: Number of patients starting at initial dose
  time frame: Time index of approximately 01 Jan 2016 to 31 March 2022
  measure: Time to chemotherapy
  time frame: Time index of approximately 01 Jan 2016 to 31 March 2022
  measure: Clinical Characteristics of Patients
  time frame: Time index of approximately 01 Jan 2016 to 31 March 2022
  measure: Demographical Characteristics of Patients
  time frame: Time index of approximately 01 Jan 2016 to 31 March 2022
  arm group label: First-line patients on Palbociclib
  description: Participants taking oral palbociclib as prescribed in first-line treatment
  intervention type: Drug
  intervention name: Palbociclib
  description: Participants taking oral palbociclib as prescribed in first-line treatment.
  arm group label: First-line patients on Palbociclib
  other name: Ibrance
  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
  last name: Pfizer CT.gov Call Center
  phone: 1-800-718-1021
  email: ClinicalTrials.gov_Inquiries@pfizer.com
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Palbociclib
  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.