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/NCT06040593</url>
    </required_header>
    <id_info>
      <org_study_id>U31402-0005-NIS-EPI</org_study_id>
      <nct_id>NCT06040593</nct_id>
    </id_info>
    <brief_title>Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer</brief_title>
    <official_title>Identify Predictors of Clinical Outcomes in Real-world Patients With HR+ and HER2-low/Negative Breast Cancer Treated With Neoadjuvant Chemotherapy or Endocrine Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Daiichi Sankyo, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Daiichi Sankyo, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        There is a lack of data on clinical and patient factors that are associated with poor&#xD;
        survival in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant&#xD;
        chemotherapy or endocrine therapy. This retrospective, non-interventional study is designed&#xD;
        to assess the predictors of clinical outcomes in this patient population. No study drug will&#xD;
        be provided as part of this study protocol.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This retrospective, non-interventional study is designed to assess the following primary&#xD;
        objectives:&#xD;
  &#xD;
          1. To identify predictors of event-free survival (EFS) in patients with HR+ and&#xD;
             HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine&#xD;
             therapy, and&#xD;
  &#xD;
          2. To stratify patients according to event-free survival using different combinations of&#xD;
             significant predictors and evaluate the patient characteristics and clinical outcomes&#xD;
             such as EFS, overall survival and pathological complete response across patient groups&#xD;
             of different risk level.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 31, 2023</start_date>
    <completion_date type="Anticipated">February 19, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer</measure>
      <time_frame>Index date to the end of the study period (approximately December 31, 2022)</time_frame>
      <description>Events of interest include any other primary cancer, metastases, higher stage, tumor progression, and death due to any cause.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall Survival of Participants With HR+ and HER2-Low/Negative Breast Cancer</measure>
      <time_frame>Index date to the end of the study period (approximately December 31, 2022)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Pathological Complete Response (pCR) in Participants With HR+ and HER2-Low/Negative Breast Cancer</measure>
      <time_frame>Index date to the end of the study period (approximately December 31, 2022)</time_frame>
      <description>Pathological complete response (pCR) was defined as ypT0/Tis ypN0 and is the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">925</enrollment>
    <condition>Hormone-receptor-positive Breast Cancer</condition>
    <condition>HER2-low Breast Cancer</condition>
    <condition>HER2-negative Breast Cancer</condition>
    <arm_group>
      <arm_group_label>HR+/HER2-low Breast Cancer</arm_group_label>
      <description>Participants with HR+/HER2-low breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HR+/HER2-negative Breast Cancer</arm_group_label>
      <description>Participants with HR+/HER2-negative breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No drug</intervention_name>
      <description>This is a non-interventional study and no study drug will be provided.</description>
      <arm_group_label>HR+/HER2-low Breast Cancer</arm_group_label>
      <arm_group_label>HR+/HER2-negative Breast Cancer</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with HR+ and HER2-low/negative breast cancer diagnosed between January 1, 2010 and&#xD;
          December 31, 2022 and treated with neoadjuvant chemotherapy or endocrine therapy will be&#xD;
          identified from the ConcertAI database based on the inclusion and exclusion criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Newly diagnosed HR+ and HER2-low/negative breast cancer diagnosed between January 1,&#xD;
               2010 and December 31, 2022 (Aged ≥18 years at the time of diagnosis)&#xD;
  &#xD;
            -  Stage I-IIIB at the time of diagnosis&#xD;
  &#xD;
            -  Received neoadjuvant chemotherapy and/or endocrine therapy and/or IO therapy&#xD;
  &#xD;
            -  Received curative intent surgery (mastectomy after neoadjuvant chemotherapy,&#xD;
               endocrine, or IO therapy)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who received HER2-targeted therapies including&#xD;
  &#xD;
                 -  Trastuzumab&#xD;
  &#xD;
                 -  Pertuzumab&#xD;
  &#xD;
                 -  Ado-trastuzumab emtansine&#xD;
  &#xD;
                 -  Neratinib&#xD;
  &#xD;
                 -  Tucatinib&#xD;
  &#xD;
                 -  Lapatinib&#xD;
  &#xD;
                 -  Fam-trastuzumab deruxtecan-nxki&#xD;
  &#xD;
                 -  Margetuximab&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>ConcertAI database</name>
        <address>
          <city>Cambridge</city>
          <state>Massachusetts</state>
          <zip>02138</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 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 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hormone-receptor-positive Breast Cancer</keyword>
    <keyword>HER2-low Breast Cancer</keyword>
    <keyword>HER2-negative Breast Cancer</keyword>
    <keyword>Real-world Data</keyword>
    <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>
    </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/NCT06040593
  org study id: U31402-0005-NIS-EPI
  nct id: NCT06040593
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  There is a lack of data on clinical and patient factors that are associated with poor
        survival in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant
        chemotherapy or endocrine therapy. This retrospective, non-interventional study is designed
        to assess the predictors of clinical outcomes in this patient population. No study drug will
        be provided as part of this study protocol.
  This retrospective, non-interventional study is designed to assess the following primary
        objectives:
  
          1. To identify predictors of event-free survival (EFS) in patients with HR+ and
             HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine
             therapy, and
  
          2. To stratify patients according to event-free survival using different combinations of
             significant predictors and evaluate the patient characteristics and clinical outcomes
             such as EFS, overall survival and pathological complete response across patient groups
             of different risk level.
  observational model: Cohort
  time perspective: Retrospective
  measure: Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer
  time frame: Index date to the end of the study period (approximately December 31, 2022)
  description: Events of interest include any other primary cancer, metastases, higher stage, tumor progression, and death due to any cause.
  measure: Overall Survival of Participants With HR+ and HER2-Low/Negative Breast Cancer
  time frame: Index date to the end of the study period (approximately December 31, 2022)
  measure: Pathological Complete Response (pCR) in Participants With HR+ and HER2-Low/Negative Breast Cancer
  time frame: Index date to the end of the study period (approximately December 31, 2022)
  description: Pathological complete response (pCR) was defined as ypT0/Tis ypN0 and is the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy.
  arm group label: HR+/HER2-low Breast Cancer
  description: Participants with HR+/HER2-low breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.
  arm group label: HR+/HER2-negative Breast Cancer
  description: Participants with HR+/HER2-negative breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.
  intervention type: Other
  intervention name: No drug
  description: This is a non-interventional study and no study drug will be provided.
  arm group label: HR+/HER2-low Breast Cancer
  arm group label: HR+/HER2-negative Breast Cancer
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No