<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/NCT02244580</url>
  </required_header>
  <id_info>
    <org_study_id>MammaTyper-FinHer</org_study_id>
    <nct_id>NCT02244580</nct_id>
  </id_info>
  <brief_title>Re-Evaluation of Tumor Samples From Women With Breast Cancer With the in Vitro Diagnostic Kit &quot;MammaTyperTM&quot;</brief_title>
  <official_title>Evaluation of the MammaTyperTM Kit, Ref 90020/90021 Performed on Clinical Material Obtained From Patients With Breast Cancer: Re-Examination of Tumor Material and Re-Evaluation of Patient Data of the FinHer-Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioNTech Diagnostics GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioNTech Diagnostics GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective examination of tumor material of breast cancer patients randomized into&#xD;
      the FinHer-trial (= (= Comparison of vinorelbine and docetaxel and trastuzumab as adjuvant&#xD;
      treatments of breast cancer patients wirh a high risk of cancer recurrence).&#xD;
&#xD;
      The formalin-fixed, paraffin-embedded tissue samples will be analysed for Estrogen receptor 1&#xD;
      (ESR1), progesterone receptor (PgR), Human epidermal growth factor receptor 2 (HER2) and&#xD;
      Antigen Ki-67 (Ki-67) with the molecular in vitro diagnostic kit MammaTyper™.&#xD;
&#xD;
      According to the new subtyping the 5 year Distant disease free survival (DDFS) and Overall&#xD;
      survival (OS) will be re-evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the fact that reliable measures for the markers ESR1, PgR, HER2, Ki-67 are necessary&#xD;
      with the currently used methods up to 20% of determinations are inaccurate and especially&#xD;
      Ki67- measures are not very reproducible. Therefore new evaluation systems or new methods are&#xD;
      necessary to improve diagnostic.&#xD;
&#xD;
      At least 4 subtypes can be distinguished to date depending on the expression of ESR, PgR,&#xD;
      Her2 and Ki-67:&#xD;
&#xD;
        -  Luminal A-type&#xD;
&#xD;
        -  Luminal B-type&#xD;
&#xD;
        -  Her2-type&#xD;
&#xD;
        -  Triple-negative-type&#xD;
&#xD;
      MammaTyper™ uses a new approach. Instead of detection of the marker proteins, the messenger&#xD;
      ribonucleic adic (mRNA) of marker proteins is quantitated. This prospectively planned&#xD;
      diagnostic study will investigate the potential of subgrouping of patients at baseline&#xD;
      according to results of MammaTyper™ methodology for predicting survival.&#xD;
&#xD;
      Patients will be subgrouped according to the new marker determination and the DDFS and OS&#xD;
      will be evaluated and compared to the DDFS and OS of subgrouping with former marker&#xD;
      determination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>5 Year Distant Disease Free Survival (DDFS) Assessed as Rate of Patients Without Distant Metastases in Subgroup Luminal A vs. Combined Subgroup (Luminal B, HER2 Positive, Triple Negative), Based on Subtyping With MammaTyper™</measure>
    <time_frame>5 year from the date of patient randomisation</time_frame>
    <description>Tumor material of breast cancer patients will be newly assessed by MammaTyper™ and 5 year DDFS will be calculated new according to new subgrouping (Luminal A vs. combined subgroup (Luminal B, HER2 positive, triple negative))</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With High Ki-67 and Prognosis on Outcome for DDFS and OS (Measured by Hazard Ratio)</measure>
    <time_frame>5 years</time_frame>
    <description>High Ki-67 is prognostic for worse outcome for DDFS and OS (measured by hazard ratio)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Ki-67 Determined by MammaTyper™ Compared to Local Ki-67 Eyeballed Assessment for Luminal Tumors and Correlation to Rate of Patients With Regard to OS and DDFS</measure>
    <time_frame>5 years</time_frame>
    <description>Superiority of outcome prediction for MammaTyper™ Ki-67 over local Ki-67 eyeballed assessment for Luminal tumors with regard to OS and DDFS</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1010</enrollment>
  <condition>Invasive Breast Cancer</condition>
  <arm_group>
    <arm_group_label>MammaTyper™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MammaTyper™ kit will be used tio assess tumor material of patients enrolled into the FinHer trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MammaTyper™</intervention_name>
    <description>MammaTyper™ kit is a molecular in vitro diagnostic test for the quantitative detection of the ribonuclease acid (RNA) expression status of the genes for estrogen receptor (ESR1), progesterone receptor (PGR), human epidermal growth factor receptor 2 (HER2) and proliferation antigen KI 67.</description>
    <arm_group_label>MammaTyper™</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Invasive breast cancer verified in a histological biopsy&#xD;
&#xD;
          -  Age 65 or younger&#xD;
&#xD;
          -  Estrogen receptor (ER), PgR and HER2 expression have been determined&#xD;
&#xD;
          -  No distant metastases present (M0)&#xD;
&#xD;
          -  The patient provides a written informed consent for study participation&#xD;
&#xD;
          -  The estimated risk of breast cancer recurrence is high (25% or higher within the first&#xD;
             5 years from the date of the diagnosis, over &gt;35% within the first 10 years from the&#xD;
             diagnosis)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with breast cancer with &quot;a special histological type&quot; (mucinous, papillary,&#xD;
             medullary, or tubular type of breast cancer) when no metastases are present in the&#xD;
             ipsilateral axillary lymph nodes&#xD;
&#xD;
          -  The WHO performance status is moderate/poor, Z &gt;1&#xD;
&#xD;
          -  The peripheral blood leukocyte count is less than 3.0 x 109/L, the blood granulocyte&#xD;
             count is less than 1.5 x 109/L, or the blood thrombocyte count is less than 120 x&#xD;
             109/L&#xD;
&#xD;
          -  Any physical or mental disorder that is considered to prohibit administration of&#xD;
             chemotherapy&#xD;
&#xD;
          -  Cardiac failure; severe cardiac arrythmia requiring regular medication&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Oed, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>BioNTech Diagnostics GmbH</affiliation>
  </overall_official>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <results_first_submitted>September 16, 2016</results_first_submitted>
  <results_first_submitted_qc>September 16, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 6, 2016</results_first_posted>
  <last_update_submitted>September 16, 2016</last_update_submitted>
  <last_update_submitted_qc>September 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Subtyping of Invasive breast cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The clinical data and breast tumour tissue samples were collected within the FinHer trial (identifier ISRCTN76560285), where 1010 women with axillary node-positive or high-risk axillary node-negative breast cancer were randomly assigned between October 2000 and September 2003.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>MammaTyper™</title>
          <description>MammaTyper™ kit will be used to assess tumor material of patients enrolled into the FinHer trial.&#xD;
MammaTyper™: MammaTyper™ kit is a molecular in vitro diagnostic test for the quantitative detection of the ribonuclease acid (RNA) expression status of the genes for estrogen receptor (ESR1), progesterone receptor (PGR), human epidermal growth factor receptor 2 (HER2) and proliferation antigen KI 67.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1010"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="769">An RT-qPCR assay was performed from breast cancer tissues of 769 out of the 1010 patients.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="241"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>No cancer tissues available</title>
              <participants_list>
                <participants group_id="P1" count="241"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Clinical data and breast tumour tissue samples were collected within the FinHer trial (identifier ISRCTN76560285).</population>
      <group_list>
        <group group_id="B1">
          <title>FinHer Patients</title>
          <description>Of all patients, FFPE tumour block was processed with the RNXtract RNA extraction kit (BioNTech Diagnostics GmbH, Mainz) using a magnetic particle-based assay (Supplemental file 1A).&#xD;
RT-qPCR was done with the MammaTyper kit (BioNTech Diagnostics GmbH, Mainz) for ESR1, PGR, ERBB2 and MKI67.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1010"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.9" lower_limit="25.5" upper_limit="65.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1010"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Finland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1010"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>5 Year Distant Disease Free Survival (DDFS) Assessed as Rate of Patients Without Distant Metastases in Subgroup Luminal A vs. Combined Subgroup (Luminal B, HER2 Positive, Triple Negative), Based on Subtyping With MammaTyper™</title>
        <description>Tumor material of breast cancer patients will be newly assessed by MammaTyper™ and 5 year DDFS will be calculated new according to new subgrouping (Luminal A vs. combined subgroup (Luminal B, HER2 positive, triple negative))</description>
        <time_frame>5 year from the date of patient randomisation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Luminal A</title>
            <description>Patients subtyped as Luminal A with DDFS determined 5 years after randomisation</description>
          </group>
          <group group_id="O2">
            <title>Combined Subtype</title>
            <description>Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation</description>
          </group>
        </group_list>
        <measure>
          <title>5 Year Distant Disease Free Survival (DDFS) Assessed as Rate of Patients Without Distant Metastases in Subgroup Luminal A vs. Combined Subgroup (Luminal B, HER2 Positive, Triple Negative), Based on Subtyping With MammaTyper™</title>
          <description>Tumor material of breast cancer patients will be newly assessed by MammaTyper™ and 5 year DDFS will be calculated new according to new subgrouping (Luminal A vs. combined subgroup (Luminal B, HER2 positive, triple negative))</description>
          <units>percentage of analyzed participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="769"/>
                <count group_id="O2" value="769"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0018</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.423</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.246</ci_lower_limit>
            <ci_upper_limit>0.726</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With High Ki-67 and Prognosis on Outcome for DDFS and OS (Measured by Hazard Ratio)</title>
        <description>High Ki-67 is prognostic for worse outcome for DDFS and OS (measured by hazard ratio)</description>
        <time_frame>5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Patients With MKI67 mRNA Determination</title>
            <description>Patients with low MKI67 mRNA</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With High Ki-67 and Prognosis on Outcome for DDFS and OS (Measured by Hazard Ratio)</title>
          <description>High Ki-67 is prognostic for worse outcome for DDFS and OS (measured by hazard ratio)</description>
          <units>Hazard ratio</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="769"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" lower_limit="0.25" upper_limit="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.25</ci_lower_limit>
            <ci_upper_limit>0.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Ki-67 Determined by MammaTyper™ Compared to Local Ki-67 Eyeballed Assessment for Luminal Tumors and Correlation to Rate of Patients With Regard to OS and DDFS</title>
        <description>Superiority of outcome prediction for MammaTyper™ Ki-67 over local Ki-67 eyeballed assessment for Luminal tumors with regard to OS and DDFS</description>
        <time_frame>5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DDFS According to MKI67 mRNA and Ki-67 Protein (IHC) Levels</title>
            <description>Determination of DDFS of patients according to MKI67 mRNA (RT-qPCR) and Ki-67 protein (IHC) levels</description>
          </group>
          <group group_id="O2">
            <title>OS According to MKI67 mRNA and Ki-67 Protein (IHC) Levels</title>
            <description>Determination of OS of patients according to MKI67 mRNA (RT-qPCR) and Ki-67 protein (IHC) levels</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Ki-67 Determined by MammaTyper™ Compared to Local Ki-67 Eyeballed Assessment for Luminal Tumors and Correlation to Rate of Patients With Regard to OS and DDFS</title>
          <description>Superiority of outcome prediction for MammaTyper™ Ki-67 over local Ki-67 eyeballed assessment for Luminal tumors with regard to OS and DDFS</description>
          <units>Hazard ratio</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="769"/>
                <count group_id="O2" value="769"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DDFS (MKI67 mRNA positive - negative)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" lower_limit="0.25" upper_limit="0.71"/>
                    <measurement group_id="O2" value="0.45" lower_limit="0.23" upper_limit="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DDFS (Ki-67 protein positive - negative)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" lower_limit="0.37" upper_limit="0.84"/>
                    <measurement group_id="O2" value="0.43" lower_limit="0.24" upper_limit="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <description>Since only tumor material was used, adverse events were not documented within the MammaTyper Study</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Michael Oed</name_or_title>
      <organization>Biontech Diagnostics GmbH</organization>
      <phone>+49 6131/ 6358030</phone>
      <email>michael.oed@theracode.de</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02244580
org study id: MammaTyper-FinHer
nct id: NCT02244580
lead sponsor: 
has dmc: No
This is a prospective examination of tumor material of breast cancer patients randomized into
      the FinHer-trial (= (= Comparison of vinorelbine and docetaxel and trastuzumab as adjuvant
      treatments of breast cancer patients wirh a high risk of cancer recurrence).

      The formalin-fixed, paraffin-embedded tissue samples will be analysed for Estrogen receptor 1
      (ESR1), progesterone receptor (PgR), Human epidermal growth factor receptor 2 (HER2) and
      Antigen Ki-67 (Ki-67) with the molecular in vitro diagnostic kit MammaTyper™.

      According to the new subtyping the 5 year Distant disease free survival (DDFS) and Overall
      survival (OS) will be re-evaluated.
Despite the fact that reliable measures for the markers ESR1, PgR, HER2, Ki-67 are necessary
      with the currently used methods up to 20% of determinations are inaccurate and especially
      Ki67- measures are not very reproducible. Therefore new evaluation systems or new methods are
      necessary to improve diagnostic.

      At least 4 subtypes can be distinguished to date depending on the expression of ESR, PgR,
      Her2 and Ki-67:

        -  Luminal A-type

        -  Luminal B-type

        -  Her2-type

        -  Triple-negative-type

      MammaTyper™ uses a new approach. Instead of detection of the marker proteins, the messenger
      ribonucleic adic (mRNA) of marker proteins is quantitated. This prospectively planned
      diagnostic study will investigate the potential of subgrouping of patients at baseline
      according to results of MammaTyper™ methodology for predicting survival.

      Patients will be subgrouped according to the new marker determination and the DDFS and OS
      will be evaluated and compared to the DDFS and OS of subgrouping with former marker
      determination.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: 5 Year Distant Disease Free Survival (DDFS) Assessed as Rate of Patients Without Distant Metastases in Subgroup Luminal A vs. Combined Subgroup (Luminal B, HER2 Positive, Triple Negative), Based on Subtyping With MammaTyper™
time frame: 5 year from the date of patient randomisation
description: Tumor material of breast cancer patients will be newly assessed by MammaTyper™ and 5 year DDFS will be calculated new according to new subgrouping (Luminal A vs. combined subgroup (Luminal B, HER2 positive, triple negative))
measure: Number of Patients With High Ki-67 and Prognosis on Outcome for DDFS and OS (Measured by Hazard Ratio)
time frame: 5 years
description: High Ki-67 is prognostic for worse outcome for DDFS and OS (measured by hazard ratio)
measure: Number of Patients With Ki-67 Determined by MammaTyper™ Compared to Local Ki-67 Eyeballed Assessment for Luminal Tumors and Correlation to Rate of Patients With Regard to OS and DDFS
time frame: 5 years
description: Superiority of outcome prediction for MammaTyper™ Ki-67 over local Ki-67 eyeballed assessment for Luminal tumors with regard to OS and DDFS
arm group label: MammaTyper™
arm group type: Experimental
description: MammaTyper™ kit will be used tio assess tumor material of patients enrolled into the FinHer trial.
intervention type: Device
intervention name: MammaTyper™
description: MammaTyper™ kit is a molecular in vitro diagnostic test for the quantitative detection of the ribonuclease acid (RNA) expression status of the genes for estrogen receptor (ESR1), progesterone receptor (PGR), human epidermal growth factor receptor 2 (HER2) and proliferation antigen KI 67.
arm group label: MammaTyper™
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Michael Oed, Dr.
role: Study Director
affiliation: BioNTech Diagnostics GmbH
responsible party type: Sponsor
mesh term: Breast Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 