<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/NCT03275311</url>
  </required_header>
  <id_info>
    <org_study_id>ESMEMBC</org_study_id>
    <nct_id>NCT03275311</nct_id>
  </id_info>
  <brief_title>Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008</brief_title>
  <acronym>ESME-MBC</acronym>
  <official_title>Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform: Evolution of the Therapeutic Care in Metastatic Breast Cancer Across the French Comprehensive Cancer Centers From 2008</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNICANCER</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pierre Fabre Laboratories</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daiichi Sankyo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seagen Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>UNICANCER</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>
      The Epidemiological Strategy and Medical Economic (ESME) Ovarian cancer Data Platform is a&#xD;
      multi-center real life database using a retrospective data collection process (18 FCCCs over&#xD;
      20 sites). This database compiles data from Patient's Electronic medical records (EMR),&#xD;
      inpatient Hospitalisation records and Pharmacy records.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This database compiles data from Patient's Electronic medical records (EMR), inpatient&#xD;
      Hospitalisation records and Pharmacy records.&#xD;
&#xD;
      Patient Database: Patient-related data integrates data from non-structured sources&#xD;
      (electronic medical records), such as patient medical records and reports of multidiscipline&#xD;
      team meetings. It can provide information on patient demographics, primitive tumour,&#xD;
      relapses, pathology reports, metastatic disease, therapeutic care/settings and withdrawal&#xD;
      reasons when applicable, and clinical events.&#xD;
&#xD;
      Treatment Database: Pharmacy records-related data is a structured database including all data&#xD;
      pertaining to medications prescribed and dispensed by pharmacies within each French&#xD;
      Comprehensive Cancer Centers (FCCC), specifically chemotherapy and co-prescriptions. It does&#xD;
      not contain information on products that are prescribed or delivered outside of the center.&#xD;
      From each center's pharmacy database, information on systemic treatment patterns (dates,&#xD;
      pharmaceutical forms, treatment protocols, etc.) can be obtained.&#xD;
&#xD;
      Hospitalization Database: Hospitalisation-related data is a structured and systematic&#xD;
      database that contains all medical data reported related to any hospitalisation in the FCCC,&#xD;
      and is used to bill the French National Health Insurance Fund (Assurance Maladie). It&#xD;
      provides information on patient entry and discharge dates as well as diagnostic and&#xD;
      therapeutic procedures performed, including radiotherapy and surgery.&#xD;
&#xD;
      Data imported into the final database are controlled, recoded, and harmonized before import&#xD;
      according to a data management plan. All coding procedures are predefined by the data&#xD;
      manager. There is no transmission of individual data; all data are centralized within each&#xD;
      center using a shared anonymous format. All data are exclusively obtained retrospectively; no&#xD;
      attempts are made to recover non available data from the patient's medical record by&#xD;
      contacting healthcare providers or patients.&#xD;
&#xD;
      ESME MBC Data Platform aims to be a clinical and therapeutic database centralising existing&#xD;
      and available data from different sources used in the FCCCs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Describe the evolution of therapeutic care</measure>
    <time_frame>baseline</time_frame>
    <description>Patient characteristics, tumor characteristics and treatment patterns</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Describe the impact of therapeutic strategies on survival criteria</measure>
    <time_frame>From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2020.</time_frame>
    <description>Overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the impact of therapeutic strategies on survival criteria</measure>
    <time_frame>From date of diagnosis or first treatment until the date of first documented progression or date of death from any cause. Follow up until 2020.</time_frame>
    <description>Progression free survival</description>
  </secondary_outcome>
  <enrollment type="Anticipated">33000</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients treated for a metastatic breast cancer in a French Comprehensive&#xD;
        Cancer Center over the selection period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  18 years old patient&#xD;
&#xD;
          -  Patient receiving chemotherapy, targeted therapy, immunotherapy, radiation therapy and&#xD;
             hormonotherapy in a French Comprehensive Cancer Center.&#xD;
&#xD;
        Exclusion criteria : None&#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>Mathieu Robain, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>UNICANCER</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mathieu Robain, MD, PhD</last_name>
    <email>m-robain@unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gaëtane Simon, Msc</last_name>
    <email>g-simon@unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut de Cancérologie de l'Ouest - Paul Papin</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Geneviève PERROCHEAU</last_name>
      <phone>+33 2 40 67 99 77</phone>
      <email>genevieve.perrocheau@ico.unicancer.fr</email>
    </contact>
    <contact_backup>
      <last_name>Loïc CAMPION</last_name>
      <email>loic.campion@ico.unicancer.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Institut Bergonié</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne JAFFRE</last_name>
      <phone>+33 5 56 33 78 48</phone>
      <email>a.jaffre@bordeaux.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <zip>14076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne-Valérie GUIZARD</last_name>
      <phone>+33 2 31 45 52 45</phone>
      <email>av.guizard@baclesse.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin</name>
      <address>
        <city>Clermont-ferrand</city>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-Ange MOURET-REYNIER</last_name>
      <phone>+33 4 73 27 81 37</phone>
      <email>marie-ange.mouret-reynier@clermont.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Georges-François Leclerc</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandrine DABAYUKO</last_name>
      <phone>+33 45 34 80 67</phone>
      <email>SDabakuyo@cgfl.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-paule LEBITASY</last_name>
      <phone>+33 3 20 29 55 60</phone>
      <email>m-lebitasy@o-lambret.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas BACHELOT</last_name>
      <phone>+33 4 78 78 26 54</phone>
      <email>thomas.bachelot@lyon.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Paoli-Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lilian LABORDE</last_name>
      <phone>+33 4 91 22 35 10</phone>
      <email>LABORDEL@ipc.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut régional du Cancer Montpellier / Val d'Aurelle</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphanie DELAINE</last_name>
      <phone>+33 4 67 61 47 39</phone>
      <email>Stephanie.delaine@icm.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de Lorraine</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carine LAURENT</last_name>
      <phone>+33 3 83 59 83 32</phone>
      <email>c.laurent@nancy.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut de cancérologie de l'Ouest - René Gauducheau</name>
      <address>
        <city>Nantes</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Geneviève PERROCHEAU</last_name>
      <phone>+33 2 40 67 99 77</phone>
      <email>genevieve.perrocheau@ico.unicancer.fr</email>
    </contact>
    <contact_backup>
      <last_name>Loïc CAMPION</last_name>
      <email>loic.campion@ico.unicancer.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emmanuel CHAMOREY</last_name>
      <phone>+33 4 92 03 15 29</phone>
      <email>emmanuel.chamorey@nice.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Etienne BRAIN</last_name>
      <email>etienne.brain@curie.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Jean Godinot</name>
      <address>
        <city>Reims</city>
        <zip>51056</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Damien PARENT</last_name>
      <phone>+33 3 26 50 42 76</phone>
      <email>damien.parent@reims.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Eugène Marquis</name>
      <address>
        <city>Rennes</city>
        <zip>35042</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathias BRETON</last_name>
      <phone>+33 2 99 25 32 67</phone>
      <email>m.breton@rennes.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Agnès LOEB</last_name>
      <phone>+33 2 32 08 22 80</phone>
      <email>agnes.loeb@chb.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Curie - Hôpital René Huguenin</name>
      <address>
        <city>Saint-Cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Etienne BRAIN</last_name>
      <phone>+33 1 47 11 15 15</phone>
      <email>etienne.brain@curie.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Paul Strauss</name>
      <address>
        <city>Strasbourg</city>
        <zip>67065</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michel VELTEN</last_name>
      <phone>+33 3 88 25 24 53</phone>
      <email>mvelten@strasbourg.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Regaud</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Delphine BERCHERY</last_name>
      <phone>05 31 15 50 60</phone>
      <email>Berchery.Delphine@iuct-oncopole.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valérie DEJEAN</last_name>
      <phone>+33 1 42 11 46 49</phone>
      <email>valerie.dejean@gustaveroussy.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Delaloge S, Perol D, Courtinard C, Brain E, Asselain B, Bachelot T, Debled M, Dieras V, Campone M, Levy C, Jacot W, Lorgis V, Veyret C, Dalenc F, Ferrero JM, Uwer L, Kerbrat P, Goncalves A, Mouret-Reynier MA, Petit T, Jouannaud C, Vanlemmens L, Chenuc G, Guesmia T, Robain M, Cailliot C. Paclitaxel plus bevacizumab or paclitaxel as first-line treatment for HER2-negative metastatic breast cancer in a multicenter national observational study. Ann Oncol. 2016 Sep;27(9):1725-32. doi: 10.1093/annonc/mdw260. Epub 2016 Jul 19.</citation>
    <PMID>27436849</PMID>
  </results_reference>
  <results_reference>
    <citation>Jacquet E, Lardy-Cleaud A, Pistilli B, Franck S, Cottu P, Delaloge S, Debled M, Vanlemmens L, Leheurteur M, Guizard AV, Laborde L, Uwer L, Jacot W, Berchery D, Desmoulins I, Ferrero JM, Perrocheau G, Courtinard C, Brain E, Chabaud S, Robain M, Bachelot T. Endocrine therapy or chemotherapy as first-line therapy in hormone receptor-positive HER2-negative metastatic breast cancer patients. Eur J Cancer. 2018 May;95:93-101. doi: 10.1016/j.ejca.2018.03.013. Epub 2018 Apr 11.</citation>
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  <results_reference>
    <citation>Gobbini E, Ezzalfani M, Dieras V, Bachelot T, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Cleaud AL, Robain M, Courtinard C, Cailliot C, Perol D, Delaloge S. Time trends of overall survival among metastatic breast cancer patients in the real-life ESME cohort. Eur J Cancer. 2018 Jun;96:17-24. doi: 10.1016/j.ejca.2018.03.015. Epub 2018 Apr 13.</citation>
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    <citation>Cabel L, Carton M, Cheaib B, Pierga JY, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Desmoulins I, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Perrocheau G, Piot I, Perol D, Simon G, Lerebours F. Oral etoposide in heavily pre-treated metastatic breast cancer: results from the ESME cohort and comparison with other chemotherapy regimens. Breast Cancer Res Treat. 2019 Jan;173(2):397-406. doi: 10.1007/s10549-018-5017-2. Epub 2018 Oct 24.</citation>
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    <citation>Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Mazouni C, Mailliez A, Pasquier D, Madranges N, Firmin N, Crouzet A, Goncalves A, Jankowski C, De La Motte Rouge T, Pouget N, de La Lande B, Mouttet-Boizat D, Ferrero JM, Uwer L, Eymard JC, Mouret-Reynier MA, Petit T, Robain M, Filleron T, Cailliot C, Dalenc F. Survival Impact of Locoregional Treatment of the Primary Tumor in De Novo Metastatic Breast Cancers in a Large Multicentric Cohort Study: A Propensity Score-Matched Analysis. Ann Surg Oncol. 2019 Feb;26(2):356-365. doi: 10.1245/s10434-018-6831-9. Epub 2018 Dec 11.</citation>
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    <citation>Perol D, Robain M, Delaloge S, Cailliot C. Routinely collected data may usefully supplement randomised controlled data on treatment effects for mortality. BMJ. 2016 Dec 16;355:i6745. doi: 10.1136/bmj.i6745. No abstract available.</citation>
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    <PMID>30744578</PMID>
  </results_reference>
  <results_reference>
    <citation>Perol D, Robain M, Arveux P, Mathoulin-Pelissier S, Chamorey E, Asselain B, Berchery D, Gourgou S, Breton M, Delaine-Clisant S, Mons M, Dieras V, Carton M, Guizard AV, Laborde L, Laurent C, Loeb A, Mouret-Reynier MA, Parent D, Perrocheau G, Campion L, Velten M, Cailliot C, Ezzalfani M, Simon G. The ongoing French metastatic breast cancer (MBC) cohort: the example-based methodology of the Epidemiological Strategy and Medical Economics (ESME). BMJ Open. 2019 Feb 21;9(2):e023568. doi: 10.1136/bmjopen-2018-023568.</citation>
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    <citation>Jacot W, Heudel PE, Fraisse J, Gourgou S, Guiu S, Dalenc F, Pistilli B, Campone M, Levy C, Debled M, Leheurteur M, Chaix M, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Courtinard C, Cottu P, Robain M, Mailliez A. Real-life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program. Int J Cancer. 2019 Dec 15;145(12):3359-3369. doi: 10.1002/ijc.32402. Epub 2019 Jun 20.</citation>
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  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metastatic breast cancer</keyword>
  <keyword>observational study</keyword>
  <keyword>survival</keyword>
  <keyword>real world data</keyword>
  <keyword>real life setting</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>


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/NCT03275311
org study id: ESMEMBC
nct id: NCT03275311
lead sponsor: 
collaborator: 
collaborator: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Epidemiological Strategy and Medical Economic (ESME) Ovarian cancer Data Platform is a
      multi-center real life database using a retrospective data collection process (18 FCCCs over
      20 sites). This database compiles data from Patient's Electronic medical records (EMR),
      inpatient Hospitalisation records and Pharmacy records.
This database compiles data from Patient's Electronic medical records (EMR), inpatient
      Hospitalisation records and Pharmacy records.

      Patient Database: Patient-related data integrates data from non-structured sources
      (electronic medical records), such as patient medical records and reports of multidiscipline
      team meetings. It can provide information on patient demographics, primitive tumour,
      relapses, pathology reports, metastatic disease, therapeutic care/settings and withdrawal
      reasons when applicable, and clinical events.

      Treatment Database: Pharmacy records-related data is a structured database including all data
      pertaining to medications prescribed and dispensed by pharmacies within each French
      Comprehensive Cancer Centers (FCCC), specifically chemotherapy and co-prescriptions. It does
      not contain information on products that are prescribed or delivered outside of the center.
      From each center's pharmacy database, information on systemic treatment patterns (dates,
      pharmaceutical forms, treatment protocols, etc.) can be obtained.

      Hospitalization Database: Hospitalisation-related data is a structured and systematic
      database that contains all medical data reported related to any hospitalisation in the FCCC,
      and is used to bill the French National Health Insurance Fund (Assurance Maladie). It
      provides information on patient entry and discharge dates as well as diagnostic and
      therapeutic procedures performed, including radiotherapy and surgery.

      Data imported into the final database are controlled, recoded, and harmonized before import
      according to a data management plan. All coding procedures are predefined by the data
      manager. There is no transmission of individual data; all data are centralized within each
      center using a shared anonymous format. All data are exclusively obtained retrospectively; no
      attempts are made to recover non available data from the patient's medical record by
      contacting healthcare providers or patients.

      ESME MBC Data Platform aims to be a clinical and therapeutic database centralising existing
      and available data from different sources used in the FCCCs.
observational model: Cohort
time perspective: Retrospective
measure: Describe the evolution of therapeutic care
time frame: baseline
description: Patient characteristics, tumor characteristics and treatment patterns
measure: Describe the impact of therapeutic strategies on survival criteria
time frame: From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2020.
description: Overall survival
measure: Describe the impact of therapeutic strategies on survival criteria
time frame: From date of diagnosis or first treatment until the date of first documented progression or date of death from any cause. Follow up until 2020.
description: Progression free survival
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mathieu Robain, MD, PhD
role: Study Director
affiliation: UNICANCER
last name: Mathieu Robain, MD, PhD
email: m-robain@unicancer.fr
last name: Gaëtane Simon, Msc
email: g-simon@unicancer.fr
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country: France
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citation: Jacot W, Heudel PE, Fraisse J, Gourgou S, Guiu S, Dalenc F, Pistilli B, Campone M, Levy C, Debled M, Leheurteur M, Chaix M, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Courtinard C, Cottu P, Robain M, Mailliez A. Real-life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program. Int J Cancer. 2019 Dec 15;145(12):3359-3369. doi: 10.1002/ijc.32402. Epub 2019 Jun 20.
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PMID: 36882736
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No