<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/NCT03027245</url>
  </required_header>
  <id_info>
    <org_study_id>E7389-M044-504</org_study_id>
    <nct_id>NCT03027245</nct_id>
  </id_info>
  <brief_title>Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy</brief_title>
  <acronym>IRENE</acronym>
  <official_title>Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study E7389-M044-504 is an observational, post-authorization, single-arm, prospective,&#xD;
      multicenter cohort study conducted to characterize and determine the incidence of&#xD;
      eribulin-induced peripheral neuropathy (PN), and the frequency and time to resolution of&#xD;
      eribulin-induced PN in adult participants treated with eribulin in a real-life setting with&#xD;
      locally advanced or metastatic breast cancer (MBC) who have progressed following at least one&#xD;
      and up to three chemotherapeutic regimens for advanced disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2016</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants experiencing eribulin-induced peripheral neuropathy (PN)</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants experiencing eribulin-induced PN</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with the indicated grade of eribulin-induced PN, as determined by Common Terminology Criteria for Adverse Events (CTCAE), grade version 4.0</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants who experienced dose modifications of eribulin treatment due to eribulin-induced PN</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants who discontinued eribulin treatment due to eribulin-induced PN</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to eribulin treatment discontinuation due to eribulin-induced PN</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of resolved cases in participants who experience eribulin-induced PN</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
    <description>A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of resolved cases in participants who experience eribulin-induced PN</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
    <description>A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to resolution of eribulin-induced PN</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
    <description>Time to resolution is defined as the time from onset (or worsening from baseline) to the date of resolution (defined as stop of PN or return to baseline), as determined by CTCAE grade version 4.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of therapeutic interventions (e.g., analgesics) being used to treat eribulin-induced PN</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life scores measured using the Patient Neurotoxicity Questionnaire</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life scores measured using the EuroQOl-5 Dimensions-3 Levels (EQ-5D-3L) questionnaire</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to disease progression</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
    <description>Time to disease progression is defined as the time from the start of eribulin treatment to Investigator assessment of disease progression (clinical or radiological)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with any serious adverse event (SAE) and number of participants with any non-serious AE</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with any SAE and percentage of participants with any non-serious AE</measure>
    <time_frame>Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">353</enrollment>
  <condition>Locally Advanced or Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Eribulin-treated participants</arm_group_label>
    <description>Participants treated with eribulin according to Fachinformation and managed according to clinical practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eribulin</intervention_name>
    <arm_group_label>Eribulin-treated participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Female participants greater than or equal to (&gt;=) 18 years with locally advanced or MBC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Locally advanced or MBC with progression after at least one chemotherapeutic regimen&#xD;
             for advanced disease eligible for treatment with eribulin according to&#xD;
             Fachinformation. Prior therapy should have included an anthracycline and a taxane in&#xD;
             either the adjuvant or metastatic setting unless participants were not suitable for&#xD;
             these treatments&#xD;
&#xD;
          -  1-3 prior chemotherapeutic regimens for advanced disease&#xD;
&#xD;
          -  Age &gt;=18 years at the time of Informed Consent&#xD;
&#xD;
          -  Ability to understand and willingness to respond to questions related to their health&#xD;
&#xD;
          -  Decision for the participant to start treatment with eribulin has been made prior to&#xD;
             inclusion in this study.&#xD;
&#xD;
          -  Signed written Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with eribulin in any line of treatment&#xD;
&#xD;
          -  Contraindication according to the Fachinformation of eribulin&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Participation in an interventional clinical trial at the same time&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Amberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Aschaffenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 2</name>
      <address>
        <city>Aschaffenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Augsburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 2</name>
      <address>
        <city>Augsburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Aurich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 2</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 3</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 2</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Darmstadt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Donauworth</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EISAI Trial Site 1</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Duren</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Esslingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Eutin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Furstenwalde</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Gelsenkirchen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Georgsmarienhütte</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Greifswald</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 2</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Hof</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Homburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Ilsede</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Karlsruhe</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Kassel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 2</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Koblenz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Koln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 2</name>
      <address>
        <city>Koln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Lahr</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Landshut</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Lemgo</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Lubeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Magdeburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Marktredwitz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Munchen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 2</name>
      <address>
        <city>Munchen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 3</name>
      <address>
        <city>Munchen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Munster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Naunhof</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Nurnberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Oberhausen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Offenbach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Offenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Oldenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Potsdam</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Puttlingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Quedlinburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Rodgau</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Rotenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Saarlouis</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Stolberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Stuttgart</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 2</name>
      <address>
        <city>Stuttgart</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Tubingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Villingen-Schwenningen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site 1</name>
      <address>
        <city>Worms</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>July 12, 2022</last_update_submitted>
  <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>locally advanced or metastatic breast cancer</keyword>
  <keyword>peripheral neuropathy</keyword>
  <keyword>chemotherapy-induced peripheral neuropathy</keyword>
  <keyword>eribulin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</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/NCT03027245
org study id: E7389-M044-504
nct id: NCT03027245
lead sponsor: 
has dmc: Yes
Study E7389-M044-504 is an observational, post-authorization, single-arm, prospective,
      multicenter cohort study conducted to characterize and determine the incidence of
      eribulin-induced peripheral neuropathy (PN), and the frequency and time to resolution of
      eribulin-induced PN in adult participants treated with eribulin in a real-life setting with
      locally advanced or metastatic breast cancer (MBC) who have progressed following at least one
      and up to three chemotherapeutic regimens for advanced disease.
observational model: Cohort
time perspective: Prospective
measure: Number of participants experiencing eribulin-induced peripheral neuropathy (PN)
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Percentage of participants experiencing eribulin-induced PN
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Number of participants with the indicated grade of eribulin-induced PN, as determined by Common Terminology Criteria for Adverse Events (CTCAE), grade version 4.0
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Percentage of participants who experienced dose modifications of eribulin treatment due to eribulin-induced PN
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Percentage of participants who discontinued eribulin treatment due to eribulin-induced PN
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Time to eribulin treatment discontinuation due to eribulin-induced PN
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Number of resolved cases in participants who experience eribulin-induced PN
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
description: A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0
measure: Percentage of resolved cases in participants who experience eribulin-induced PN
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
description: A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0
measure: Time to resolution of eribulin-induced PN
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
description: Time to resolution is defined as the time from onset (or worsening from baseline) to the date of resolution (defined as stop of PN or return to baseline), as determined by CTCAE grade version 4.0.
measure: Number of therapeutic interventions (e.g., analgesics) being used to treat eribulin-induced PN
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Health-related quality of life scores measured using the Patient Neurotoxicity Questionnaire
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Health-related quality of life scores measured using the EuroQOl-5 Dimensions-3 Levels (EQ-5D-3L) questionnaire
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Time to disease progression
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
description: Time to disease progression is defined as the time from the start of eribulin treatment to Investigator assessment of disease progression (clinical or radiological)
measure: Number of participants with any serious adverse event (SAE) and number of participants with any non-serious AE
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Percentage of participants with any SAE and percentage of participants with any non-serious AE
time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
arm group label: Eribulin-treated participants
description: Participants treated with eribulin according to Fachinformation and managed according to clinical practice
intervention type: Drug
intervention name: Eribulin
arm group label: Eribulin-treated participants
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Germany
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
sharing ipd: No