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/NCT05981326</url>
    </required_header>
    <id_info>
      <org_study_id>ICO-2023-08</org_study_id>
      <nct_id>NCT05981326</nct_id>
    </id_info>
    <brief_title>Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients</brief_title>
    <acronym>NEOEPICURE</acronym>
    <official_title>Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut Cancerologie de l'Ouest</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institut Cancerologie de l'Ouest</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Breast cancer (BC) is the most common cancer in women in France with nearly 58,500 new cases&#xD;
        and 12,150 deaths estimated in 2018 .&#xD;
  &#xD;
        Two major achievements have been made in the last five years for breast cancer patients. The&#xD;
        first is therapeutic with the approval of immune checkpoint inhibitors in advanced and early&#xD;
        triple-negative BC (TNBC) and the impressive efficacy of new antibody-drug conjugated in all&#xD;
        BC subtypes. The second is conceptual with the generalization of adaptive therapeutic&#xD;
        strategies guided by pathological responses after neoadjuvant therapy in early TNBC, HER2+,&#xD;
        HR+ and BRCA mutated breast cancer. This new paradigm in the treatment of cancer patients&#xD;
        completely redefined prognostic factors that were previously established with conventional&#xD;
        approaches Pathological response remains a major prognostic factor especially for TNBC and&#xD;
        HER2 early breast cancer. However, this parameter is evaluated at the end of neoadjuvant&#xD;
        treatment and for patients with residual disease, the prognosis remains poor despite some&#xD;
        adaptative strategies.&#xD;
  &#xD;
        Our project is to integrate massive and heterogeneous data concerning the disease (clinical&#xD;
        and biological data, imaging and histological results (with multi-omics data)) and patient's&#xD;
        environment, personal and familial history. These data are multiple and have dynamic&#xD;
        interactions overtime. With the help of mathematical units with biological competences and&#xD;
        scientific collaborations, our project is to improve the prediction of treatment response,&#xD;
        based on clinical and molecular heterogeneous big data investigation.&#xD;
  &#xD;
        The main objective of this project is to set up a clinicobiological database prospectively by&#xD;
        collecting prospective clinical, biological, pathological and multi-omic data from 300&#xD;
        Patients with early BC treated at the ICO in order to define an algorithm of individual&#xD;
        decision for the prediction of the response to this treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">April 2033</completion_date>
    <primary_completion_date type="Anticipated">April 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The accurancy predictive parameters for complete pathological response (pCR) after neoadjuvant chemotherapy</measure>
      <time_frame>6 months after the initiation of neoadjuvant chemotherapy</time_frame>
      <description>The primary endpoint is the predictive yield of complete pathological response (pCR) after the neoaduvant treatment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To determine the rate of Event Free Survival</measure>
      <time_frame>5 years after the initiation of treatment</time_frame>
      <description>The primary endpoint is the predictive yield of Event Free Survial up to 5 years</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To determine the rate of Overall Survival</measure>
      <time_frame>5 years after the initiation of treatment</time_frame>
      <description>The primary endpoint is the predictive yield of overall Survival up to 5 years</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>cohort: triple negative breast cancer</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Standard drug: Neoadjuvant treatment : Weekly paclitaxel + carboplatin + pembrolizumab (TCP) followed by EC90 *4 pembrolizumab&#xD;
  Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite</description>
    </arm_group>
    <arm_group>
      <arm_group_label>cohort: HER2+ breast cancer</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Standard drug:&#xD;
  EC100 followed by docetaxel + trastuzumab or EC100 followed by paclitaxel + trastuzumab Docetaxel + carboplatin + trastuzumab *6 folowed by trastuzumab alone&#xD;
  Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite</description>
    </arm_group>
    <arm_group>
      <arm_group_label>cohort: ER/PR+ /HER2- breast cancer</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Standard drug: EC100 paclitaxel or EC100 docetaxel&#xD;
  Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Biopsy</intervention_name>
      <description>biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment</description>
      <arm_group_label>cohort: ER/PR+ /HER2- breast cancer</arm_group_label>
      <arm_group_label>cohort: HER2+ breast cancer</arm_group_label>
      <arm_group_label>cohort: triple negative breast cancer</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Blood samples</intervention_name>
      <description>Centralized blood samples will be performed at inclusion + evaluation visits</description>
      <arm_group_label>cohort: ER/PR+ /HER2- breast cancer</arm_group_label>
      <arm_group_label>cohort: HER2+ breast cancer</arm_group_label>
      <arm_group_label>cohort: triple negative breast cancer</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Questionnaires</intervention_name>
      <description>Food inquiry + food-frequency questionnaire + physical activity questionnaire will be performed at inclusion</description>
      <arm_group_label>cohort: ER/PR+ /HER2- breast cancer</arm_group_label>
      <arm_group_label>cohort: HER2+ breast cancer</arm_group_label>
      <arm_group_label>cohort: triple negative breast cancer</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Written informed consent obtained from the patient prior to performing any&#xD;
               protocol-related procedures, including screening biopsy, blood samples and&#xD;
               questionnaires&#xD;
  &#xD;
            2. 18 years old or at time of written consent&#xD;
  &#xD;
            3. Patient with histologically confirmed breast cancer&#xD;
  &#xD;
            4. Absence of metastatic disease&#xD;
  &#xD;
            5. Patient requiring neoadjuvant chemotherapy&#xD;
  &#xD;
            6. Performance status ≤ 2 (according to WHO criteria)&#xD;
  &#xD;
            7. Indication of any systemic therapeutic strategy can be performed alongside this&#xD;
               current cohort in accordance with national and / or international recommendations.&#xD;
  &#xD;
            8. Patient is willing and able to comply with the protocol for the duration of the study&#xD;
               including undergoing treatment and scheduled visits and examinations including follow&#xD;
               up.&#xD;
  &#xD;
            9. Patient must be affiliated to a Social Health Insurance&#xD;
  &#xD;
           10. For patients taking part in the RTW WP: working patients at time of diagnostic and in&#xD;
               sick leave at time of inclusion&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or&#xD;
               in situ carcinoma of the cervix)&#xD;
  &#xD;
            2. Non epithelial breast cancer&#xD;
  &#xD;
            3. Coagulopathy or other pathology that contraindicates biopsy procedures&#xD;
  &#xD;
            4. Pregnant or nursing patient&#xD;
  &#xD;
            5. Individual deprived of liberty or placed under the authority of a tutor&#xD;
  &#xD;
            6. Impossibility to submit to the medical follow-up of this clinical trial for&#xD;
               geographical, social or psychological reasons&#xD;
  &#xD;
            7. For patients taking part in the RTW WP: patient in an &quot;self employed&quot; or &quot;interim&quot;&#xD;
               employment situation&#xD;
  &#xD;
            8. For patients taking part in the RTW WP: Patients working part-timeProcedures for&#xD;
               withdrawal of incorrectly enrolled patients are presented in Section 7.5.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jean Sebastien FRENEL, MD</last_name>
      <role>Study Director</role>
      <affiliation>Institut de Cancérologie de l'Ouest</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jean Sebastien FRENEL, MD</last_name>
      <phone>+33240679900</phone>
      <phone_ext>+33</phone_ext>
      <email>jean-sebastien.frenel@ico.unicancer.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marine TIGREAT</last_name>
      <phone>+33240679878</phone>
      <phone_ext>+33</phone_ext>
      <email>marine.tigreat@ico.unicancer.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Institut de Cancérologie de l'Ouest</name>
        <address>
          <city>Angers</city>
          <zip>49055</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Anne PASTSOURIS, MD</last_name>
        <email>anne.patsouris@ico.unicancer.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Institut de Cancérologie de l'Ouest</name>
        <address>
          <city>Saint-Herblain</city>
          <zip>44805</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Jean Sébastien FRENEL, MD</last_name>
        <email>jean-sebastien@ico.unicancer.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Neo adjuvant chemotherapy</keyword>
    <keyword>Multi omic analysis</keyword>
    <keyword>Predilection in silico</keyword>
    <keyword>Prospective clinico database</keyword>
    <keyword>Surgery</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/NCT05981326
  org study id: ICO-2023-08
  nct id: NCT05981326
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Breast cancer (BC) is the most common cancer in women in France with nearly 58,500 new cases
        and 12,150 deaths estimated in 2018 .
  
        Two major achievements have been made in the last five years for breast cancer patients. The
        first is therapeutic with the approval of immune checkpoint inhibitors in advanced and early
        triple-negative BC (TNBC) and the impressive efficacy of new antibody-drug conjugated in all
        BC subtypes. The second is conceptual with the generalization of adaptive therapeutic
        strategies guided by pathological responses after neoadjuvant therapy in early TNBC, HER2+,
        HR+ and BRCA mutated breast cancer. This new paradigm in the treatment of cancer patients
        completely redefined prognostic factors that were previously established with conventional
        approaches Pathological response remains a major prognostic factor especially for TNBC and
        HER2 early breast cancer. However, this parameter is evaluated at the end of neoadjuvant
        treatment and for patients with residual disease, the prognosis remains poor despite some
        adaptative strategies.
  
        Our project is to integrate massive and heterogeneous data concerning the disease (clinical
        and biological data, imaging and histological results (with multi-omics data)) and patient's
        environment, personal and familial history. These data are multiple and have dynamic
        interactions overtime. With the help of mathematical units with biological competences and
        scientific collaborations, our project is to improve the prediction of treatment response,
        based on clinical and molecular heterogeneous big data investigation.
  
        The main objective of this project is to set up a clinicobiological database prospectively by
        collecting prospective clinical, biological, pathological and multi-omic data from 300
        Patients with early BC treated at the ICO in order to define an algorithm of individual
        decision for the prediction of the response to this treatment.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: The accurancy predictive parameters for complete pathological response (pCR) after neoadjuvant chemotherapy
  time frame: 6 months after the initiation of neoadjuvant chemotherapy
  description: The primary endpoint is the predictive yield of complete pathological response (pCR) after the neoaduvant treatment
  measure: To determine the rate of Event Free Survival
  time frame: 5 years after the initiation of treatment
  description: The primary endpoint is the predictive yield of Event Free Survial up to 5 years
  measure: To determine the rate of Overall Survival
  time frame: 5 years after the initiation of treatment
  description: The primary endpoint is the predictive yield of overall Survival up to 5 years
  arm group label: cohort: triple negative breast cancer
  arm group type: Experimental
  description: Standard drug: Neoadjuvant treatment : Weekly paclitaxel + carboplatin + pembrolizumab (TCP) followed by EC90 *4 pembrolizumab
  Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite
  arm group label: cohort: HER2+ breast cancer
  arm group type: Experimental
  description: Standard drug:
  EC100 followed by docetaxel + trastuzumab or EC100 followed by paclitaxel + trastuzumab Docetaxel + carboplatin + trastuzumab *6 folowed by trastuzumab alone
  Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite
  arm group label: cohort: ER/PR+ /HER2- breast cancer
  arm group type: Experimental
  description: Standard drug: EC100 paclitaxel or EC100 docetaxel
  Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite
  intervention type: Procedure
  intervention name: Biopsy
  description: biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment
  arm group label: cohort: ER/PR+ /HER2- breast cancer
  arm group label: cohort: HER2+ breast cancer
  arm group label: cohort: triple negative breast cancer
  intervention type: Procedure
  intervention name: Blood samples
  description: Centralized blood samples will be performed at inclusion + evaluation visits
  arm group label: cohort: ER/PR+ /HER2- breast cancer
  arm group label: cohort: HER2+ breast cancer
  arm group label: cohort: triple negative breast cancer
  intervention type: Behavioral
  intervention name: Questionnaires
  description: Food inquiry + food-frequency questionnaire + physical activity questionnaire will be performed at inclusion
  arm group label: cohort: ER/PR+ /HER2- breast cancer
  arm group label: cohort: HER2+ breast cancer
  arm group label: cohort: triple negative breast cancer
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jean Sebastien FRENEL, MD
  role: Study Director
  affiliation: Institut de Cancérologie de l'Ouest
  last name: Jean Sebastien FRENEL, MD
  phone: +33240679900
  phone ext: +33
  email: jean-sebastien.frenel@ico.unicancer.fr
  last name: Marine TIGREAT
  phone: +33240679878
  phone ext: +33
  email: marine.tigreat@ico.unicancer.fr
  facility: 
  contact: 
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No