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/NCT06010615</url>
    </required_header>
    <id_info>
      <org_study_id>2023/785</org_study_id>
      <nct_id>NCT06010615</nct_id>
    </id_info>
    <brief_title>Relative Dose Intensity of Adjuvant Chemotherapy in Older Women With ER+ HER2- Breast Cancer.</brief_title>
    <acronym>BREASTOLD</acronym>
    <official_title>Relative Dose Intensity of Adjuvant Chemotherapy in Older Women With ER+ HER2- Breast Cancer.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Besancon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Besancon</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>
        Localized breast cancers are defined as high-risk when they include lymph node involvement,&#xD;
        Ki67 &gt;30%, vascular emboli, low hormone receptor expression, or an unfavorable genomic&#xD;
        signature result.&#xD;
  &#xD;
        Under these conditions, sequential adjuvant chemotherapy with taxanes and anthracyclines is&#xD;
        recommended.&#xD;
  &#xD;
        Patients over 75 years of age receiving adjuvant chemotherapy are at greater risk of&#xD;
        side-effects, which may necessitate dose reductions and a reduction in the intensity of&#xD;
        chemotherapy. For curative adjuvant treatment, it is recommended to maintain a relative dose&#xD;
        intensity (RDI) &gt; 85%. A few publications have demonstrated the prognostic impact of a&#xD;
        relative dose intensity &lt; 85% for patients aged over 65. For several years now, the need for&#xD;
        a specific assessment of elderly patients has been emphasized, prior to initiating&#xD;
        oncological treatment (G8 score, onco-geriatric consultation).&#xD;
  &#xD;
        This study is a retrospective descriptive study of patients aged over 75 treated with&#xD;
        adjuvant chemotherapy from 01/01/2012 to 01/01/2020 for RH+ HER2 - breast cancer in Franche&#xD;
        Comté.&#xD;
  &#xD;
        Thus the investigators wish to identify patients at risk of receiving sub-optimal relative&#xD;
        dose intensity, in order to guide early and targeted supportive care or geriatric&#xD;
        co-management interventions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">June 20, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 20, 2025</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 relative dose intensity (RDI) &lt;85%</measure>
      <time_frame>01/01/2012 to 31/12/2019</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Breast Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients aged 75 and over with RH+ HER2- breast cancer who received adjuvant chemotherapy&#xD;
          between 01/01/2012 and 01/01/2020, within the Regional Cancer Network of&#xD;
          Bourgogne-Franche-Comté - oncoBFC&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women aged 75 or over&#xD;
  &#xD;
            -  Patient with localized RH+HER2- breast cancer&#xD;
  &#xD;
            -  Patient treated with adjuvant chemotherapy in Franche Comté between January 2012 and&#xD;
               December 2019&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt; 75&#xD;
  &#xD;
            -  Patient with metastatic breast cancer&#xD;
  &#xD;
            -  Patient who received neoadjuvant chemotherapy&#xD;
  &#xD;
            -  HER2+ breast cancer patient&#xD;
  &#xD;
            -  Breast cancer patient with missing or negative hormonal status&#xD;
  &#xD;
            -  Patient with localized recurrence of breast cancer with indication for new adjuvant&#xD;
               therapy&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>75 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</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>
    </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/NCT06010615
  org study id: 2023/785
  nct id: NCT06010615
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Localized breast cancers are defined as high-risk when they include lymph node involvement,
        Ki67 >30%, vascular emboli, low hormone receptor expression, or an unfavorable genomic
        signature result.
  
        Under these conditions, sequential adjuvant chemotherapy with taxanes and anthracyclines is
        recommended.
  
        Patients over 75 years of age receiving adjuvant chemotherapy are at greater risk of
        side-effects, which may necessitate dose reductions and a reduction in the intensity of
        chemotherapy. For curative adjuvant treatment, it is recommended to maintain a relative dose
        intensity (RDI) > 85%. A few publications have demonstrated the prognostic impact of a
        relative dose intensity < 85% for patients aged over 65. For several years now, the need for
        a specific assessment of elderly patients has been emphasized, prior to initiating
        oncological treatment (G8 score, onco-geriatric consultation).
  
        This study is a retrospective descriptive study of patients aged over 75 treated with
        adjuvant chemotherapy from 01/01/2012 to 01/01/2020 for RH+ HER2 - breast cancer in Franche
        Comté.
  
        Thus the investigators wish to identify patients at risk of receiving sub-optimal relative
        dose intensity, in order to guide early and targeted supportive care or geriatric
        co-management interventions.
  observational model: Cohort
  time perspective: Retrospective
  measure: Proportion of patients receiving relative dose intensity (RDI) <85%
  time frame: 01/01/2012 to 31/12/2019
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 75 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No