<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/NCT04403984</url>
  </required_header>
  <id_info>
    <org_study_id>HE10A13</org_study_id>
    <nct_id>NCT04403984</nct_id>
  </id_info>
  <brief_title>Investigation of Genomic Alteration in Patients With Luminal A or Luminal B Subtypes</brief_title>
  <official_title>Investigation of the Prognostic Value of Genomic Alterations or Protein Expression in Patients With Operated Early Breast Cancer of Luminal A or Luminal B Subtypes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hellenic Cooperative Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hellenic Cooperative Oncology Group</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>
      This is a translational study in patients with operated early breast cancer of Luminal A or&#xD;
      Luminal B sub types.The Hellenic Cooperative Oncology Group (HeCOG) has designed an&#xD;
      observational biomarker-driven study in patients with Luminal A or Luminal B breast cancer,&#xD;
      with the aim to collect valuable biological material from these patients and investigate&#xD;
      biomarkers with potential prognostic value.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The HE10A/13 study is an observational study of the Hellenic Cooperative Oncology Group&#xD;
      (HeCOG). Its main purpose is the collection of biological material from patients in search of&#xD;
      prognostic / predictive biomarkers. Each patient signed an informed consent for the provision&#xD;
      of biologic material for future research purposes. The study was conducted in accordance with&#xD;
      the Declaration of Helsinki. The clinical and translational protocol has been approved by the&#xD;
      Hellenic Cooperative Oncology Group Scientific Committee and is under review by the&#xD;
      Institutional Review Board of Metropolitan Hospital. Patients exclusively with Luminal A or&#xD;
      Luminal B (Estrogen Receptors (ER)-positive with or without Progesterone Receptors (PgR)&#xD;
      positive, HER-negative) breast cancer who received adjuvant chemotherapy with positive lymph&#xD;
      nodes or node-negative with tumor stage or pathological features according to Saint Gallen&#xD;
      guidelines suggesting high-risk or when genomic testing determined in favor of adjuvant&#xD;
      chemotherapy are eligible for registration in the study.&#xD;
&#xD;
      Before registration to the study, each patient signed an informed consent for the provision&#xD;
      of biologic material for research purposes.&#xD;
&#xD;
      Potential biomarkers will be examined using in situ or molecular methods in Formalin fixed&#xD;
      paraffin embedded (FFPE) tumor sections. For tumor subtyping immunohistochemistry for ER,&#xD;
      PgR, HER2, Ki67 and Fluorescence in Situ Hybridization (FISH) will be performed where needed&#xD;
      for the assessment of HER2 status; for Epidermal Growth Factor Receptor (EGFR) and CK5 for&#xD;
      the classification of basal-like tumors; and, the expression of CD8, CD3 and FOXP3 on (Tumor-&#xD;
      infiltrating Lymphocytes (TILs) will also be evaluated. Moreover, will be evaluated the&#xD;
      mutational profile, including actionable genomic alterations, and the immune response&#xD;
      -related profile of Greek women with breast cancer, via the application of DNA/RNA Next&#xD;
      Generation Sequencing (NGS) technologies, relative also to patient outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 24, 2013</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Actual">December 21, 2020</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</measure>
    <time_frame>From treatment initiation to the first documented disease progression, up to 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From date of treatment initiation until death from any cause or date of last contact whichever occurred first, assessed up to 5 years.</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">750</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Patients with Luminal A breast cancer</arm_group_label>
    <description>Patients confirmed with Luminal A breast cancer sub type</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with Luminal B breast cancer</arm_group_label>
    <description>Patients confirmed with Luminal B breast cancer sub type</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This is a retrospective analysis of patients with operative early breast cancer of Luminal&#xD;
        A and Luminal B sub types. Patients have been treated in Hellenic Cooperative Oncology&#xD;
        Group (HeCOG) - affiliated departments of Oncology.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or older&#xD;
&#xD;
          -  Luminal A breast cancer sub type&#xD;
&#xD;
          -  Luminal B breast cancer sub type&#xD;
&#xD;
          -  Positive lymph nodes&#xD;
&#xD;
          -  Node- negative with tumor stage or pathological features according to Saint Gallen&#xD;
             guidelines.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>George Fountzilas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hellenic Cooperative Oncology Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>George Fountzilas</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
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  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Early breast cancer</keyword>
  <keyword>Luminal A breast cancer</keyword>
  <keyword>Luminal B breast cancer</keyword>
  <keyword>Operated breast cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04403984
org study id: HE10A13
nct id: NCT04403984
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a translational study in patients with operated early breast cancer of Luminal A or
      Luminal B sub types.The Hellenic Cooperative Oncology Group (HeCOG) has designed an
      observational biomarker-driven study in patients with Luminal A or Luminal B breast cancer,
      with the aim to collect valuable biological material from these patients and investigate
      biomarkers with potential prognostic value.
The HE10A/13 study is an observational study of the Hellenic Cooperative Oncology Group
      (HeCOG). Its main purpose is the collection of biological material from patients in search of
      prognostic / predictive biomarkers. Each patient signed an informed consent for the provision
      of biologic material for future research purposes. The study was conducted in accordance with
      the Declaration of Helsinki. The clinical and translational protocol has been approved by the
      Hellenic Cooperative Oncology Group Scientific Committee and is under review by the
      Institutional Review Board of Metropolitan Hospital. Patients exclusively with Luminal A or
      Luminal B (Estrogen Receptors (ER)-positive with or without Progesterone Receptors (PgR)
      positive, HER-negative) breast cancer who received adjuvant chemotherapy with positive lymph
      nodes or node-negative with tumor stage or pathological features according to Saint Gallen
      guidelines suggesting high-risk or when genomic testing determined in favor of adjuvant
      chemotherapy are eligible for registration in the study.

      Before registration to the study, each patient signed an informed consent for the provision
      of biologic material for research purposes.

      Potential biomarkers will be examined using in situ or molecular methods in Formalin fixed
      paraffin embedded (FFPE) tumor sections. For tumor subtyping immunohistochemistry for ER,
      PgR, HER2, Ki67 and Fluorescence in Situ Hybridization (FISH) will be performed where needed
      for the assessment of HER2 status; for Epidermal Growth Factor Receptor (EGFR) and CK5 for
      the classification of basal-like tumors; and, the expression of CD8, CD3 and FOXP3 on (Tumor-
      infiltrating Lymphocytes (TILs) will also be evaluated. Moreover, will be evaluated the
      mutational profile, including actionable genomic alterations, and the immune response
      -related profile of Greek women with breast cancer, via the application of DNA/RNA Next
      Generation Sequencing (NGS) technologies, relative also to patient outcome.
observational model: Cohort
time perspective: Retrospective
measure: Progression free survival
time frame: From treatment initiation to the first documented disease progression, up to 5 years
measure: Overall survival
time frame: From date of treatment initiation until death from any cause or date of last contact whichever occurred first, assessed up to 5 years.
arm group label: Patients with Luminal A breast cancer
description: Patients confirmed with Luminal A breast cancer sub type
arm group label: Patients with Luminal B breast cancer
description: Patients confirmed with Luminal B breast cancer sub type
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: George Fountzilas, MD
role: Principal Investigator
affiliation: Hellenic Cooperative Oncology Group
facility: 
country: Greece
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responsible party type: Sponsor
mesh term: Breast Neoplasms