<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/NCT01722890</url>
  </required_header>
  <id_info>
    <org_study_id>ICORG 12-09</org_study_id>
    <nct_id>NCT01722890</nct_id>
  </id_info>
  <brief_title>CharactHer. ICORG 12-09, V3</brief_title>
  <official_title>CharactHer: A Study of the Molecular and Cytogenetic Characteristics of HER2-positive Breast Cancers to Predict Durable Complete Response After Chemotherapy and Trastuzumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Trials Ireland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Trials Ireland</source>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      The primary aim of the study is:&#xD;
&#xD;
      1.To identify and validate a panel of molecular and cytogenetic biomarkers able to predict&#xD;
      Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with&#xD;
      HER2-positive locally advanced or metastatic breast cancer.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      The secondary aims of the study are:&#xD;
&#xD;
        1. To perform a comprehensive exploration of the molecular and cytogenetic characteristics&#xD;
           of DCR patients to identify any possible correlation between the tumour's biological and&#xD;
           cytogenetic characteristics and the degree of clinical response to trastuzumab;&#xD;
&#xD;
        2. To produce data in preparation for further translational studies on HER2-positive breast&#xD;
           cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type of Study: Translational&#xD;
&#xD;
      This is a pilot retrospective laboratory-based cohort study.&#xD;
&#xD;
      Eligible patients will be identified at each one of the participating institutions by a&#xD;
      systematic cross-matching of the datasets of Medical Oncology, Pathology and Pharmacy&#xD;
      Departments.&#xD;
&#xD;
      Patient Population:&#xD;
&#xD;
      Cohort 1: TNM stage II-IV breast cancer patients with highly trastuzumab-sensitive tumours.&#xD;
&#xD;
      Cohort 2: (Control group) TNM stage II-IV breast cancer patients with trastuzumab-refractory&#xD;
      disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    As per the HRBs new funding model, HRBs investment will not support costs associated with&#xD;
    routine patient care or translational studies, biobanks, patient registries and questionnaires.&#xD;
    Therefore, a decision was made to cease further study follow up.&#xD;
  </why_stopped>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">January 27, 2021</completion_date>
  <primary_completion_date type="Actual">January 27, 2021</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>Panel of molecular and cytogenetic biomarkers able to predict Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with HER2-positive locally advanced or metastatic breast cancer.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">130</enrollment>
  <condition>HER2-positive Breast Cancer</condition>
  <condition>TNM Stage II-IV Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>TNM stage II-IV breast cancer patients with highly trastuzumab-sensitive tumours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2(Control Group)</arm_group_label>
    <description>TNM stage II-IV breast cancer patients with trastuzumab-refractory disease.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Study population will consist of two separate cohorts of patients with HER2-positive breast&#xD;
        cancer that will be analysed based on their responsiveness to trastuzumab-containing&#xD;
        chemotherapy. Cohort 1 will include patients with TNM stage II-IV breast cancer with highly&#xD;
        trastuzumab-sensitive tumours. Results of laboratory analyses from Cohort 1 will be matched&#xD;
        with those from Cohort 2 (Control group) that includes patients at the same TNM clinical&#xD;
        stages but with trastuzumab-refractory disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria for Cohort 1:&#xD;
&#xD;
          1. Histologically proven AJCC TNM stage II-IV invasive breast cancer&#xD;
&#xD;
          2. HER2-positivity defined as score 3+ on IHC and/or with HER2/neu amplification on FISH&#xD;
             test (HER2/CEP17 ratio &gt;2.0 on PathVysion test)&#xD;
&#xD;
          3. Evidence of complete response (CR) according to RECIST 1.1 criteria lasting for at&#xD;
             least 36 months (for stage IV patients only) following a first-line chemotherapy and&#xD;
             trastuzumab&#xD;
&#xD;
          4. Pathological Complete Response (pCR) following a neo-adjuvant chemotherapy (CT) and&#xD;
             trastuzumab (for stage II-III patients only). pCR is defined as no evidence of&#xD;
             residual invasive carcinoma in the breast (ductal carcinoma in situ (DCIS) is allowed)&#xD;
             AND in all the examined lymph nodes (micro-metastases and isolated tumour cells are&#xD;
             not allowed).&#xD;
&#xD;
          5. At least one FFPE archived tissue sample from the primary tumour and/or a metastatic&#xD;
             site(s) available for laboratory analyses&#xD;
&#xD;
          6. Adequate follow up information&#xD;
&#xD;
        Inclusion criteria for Cohort 2:&#xD;
&#xD;
          1. Histologically proven AJCC TNM stage II-IV invasive breast cancer&#xD;
&#xD;
          2. HER2-positivity defined as score 3+ on IHC and/or with HER2/neu amplification on FISH&#xD;
             test (HER2/CEP17 ratio&gt;2.0 on PathVysion test)&#xD;
&#xD;
          3. Progression of disease according to RECIST 1.1 while receiving trastuzumab (in&#xD;
             association with chemotherapy or as single agent as maintenance therapy) or within 6&#xD;
             months from last dose of trastuzumab (for stage IV patients only)&#xD;
&#xD;
          4. Residual invasive tumour in the breast larger than 2cm and /or at least one micro- or&#xD;
             macro-metastasis in the axillary lymph nodes following pre-operative&#xD;
             trastuzumab-containing chemotherapy (for stage II-III patients only)&#xD;
&#xD;
          5. At least one FFPE archived tissue sample from the primary tumour and/or a metastatic&#xD;
             site(s) available for laboratory analyses&#xD;
&#xD;
          6. Adequate follow up information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Any deviation from the above mentioned Inclusion criteria&#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>Giuseppe Gullo, Medicine and Surgery</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Vincent's University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Vincents University Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Humanitas Cancer Centre Milan</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HER2-positive breast cancer</keyword>
  <keyword>durable complete response</keyword>
  <keyword>cytogenetic characteristics</keyword>
  <keyword>molecular characteristics</keyword>
  <keyword>trastuzumab</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/NCT01722890
org study id: ICORG 12-09
nct id: NCT01722890
lead sponsor: 
Primary Objective:

      The primary aim of the study is:

      1.To identify and validate a panel of molecular and cytogenetic biomarkers able to predict
      Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with
      HER2-positive locally advanced or metastatic breast cancer.

      Secondary Objective:

      The secondary aims of the study are:

        1. To perform a comprehensive exploration of the molecular and cytogenetic characteristics
           of DCR patients to identify any possible correlation between the tumour's biological and
           cytogenetic characteristics and the degree of clinical response to trastuzumab;

        2. To produce data in preparation for further translational studies on HER2-positive breast
           cancer.
Type of Study: Translational

      This is a pilot retrospective laboratory-based cohort study.

      Eligible patients will be identified at each one of the participating institutions by a
      systematic cross-matching of the datasets of Medical Oncology, Pathology and Pharmacy
      Departments.

      Patient Population:

      Cohort 1: TNM stage II-IV breast cancer patients with highly trastuzumab-sensitive tumours.

      Cohort 2: (Control group) TNM stage II-IV breast cancer patients with trastuzumab-refractory
      disease.
observational model: Cohort
time perspective: Retrospective
measure: Panel of molecular and cytogenetic biomarkers able to predict Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with HER2-positive locally advanced or metastatic breast cancer.
time frame: 2 years
arm group label: Cohort 1
description: TNM stage II-IV breast cancer patients with highly trastuzumab-sensitive tumours.
arm group label: Cohort 2(Control Group)
description: TNM stage II-IV breast cancer patients with trastuzumab-refractory disease.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Giuseppe Gullo, Medicine and Surgery
role: Principal Investigator
affiliation: St. Vincent's University Hospital
facility: 
facility: 
country: Ireland
country: Italy
responsible party type: Sponsor
mesh term: Breast Neoplasms