<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/NCT03245112</url>
  </required_header>
  <id_info>
    <org_study_id>201700596B0</org_study_id>
    <nct_id>NCT03245112</nct_id>
  </id_info>
  <brief_title>Halaven Patient Registry (Metastatic Breast Cancer, MBC)</brief_title>
  <official_title>Retrospective Data Collection and Analysis of the Therapeutic Effect of Eribulin for Advanced Breast Cancer Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaohsiung Breast Cancer Prevention and Education Society (KBCPES)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eisai Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since the first marketing authorization in the world in November 2010 granted by US FDA,&#xD;
      Halaven has been approved for clinical use in more than 40 countries worldwide, including&#xD;
      many Asian countries, e.g. Hong Kong, India, Japan, Malaysia, Myanmar, Philippines, South&#xD;
      Korea, Singapore, Taiwan and Thailand. According to two large global phase III study reports&#xD;
      of Halaven, very few Asian patients participated in these studies. In a phase II study of&#xD;
      Halaven with metastatic breast cancer, the clinical efficacy and toxicity were reported only&#xD;
      in 80 Japanese patients. Halaven has been granted its marketing authorization in Singapore&#xD;
      since February 2011. However, most of other Asian countries including India have had the&#xD;
      approval and launched from middle year of 2013 or in early 2014. Limited information of&#xD;
      Halaven using in Asian patients are available except several case experience exchange&#xD;
      presented by individual medical centers or as personal experience in the past. Some clinical&#xD;
      concerns related to Halaven use are raised by clinicians during their clinical practice, such&#xD;
      as how Halaven works on Asian patients, which type of patient obtains better clinical benefit&#xD;
      from Halaven, and what are the main treatment related toxicities in Asian which may differ&#xD;
      from Westerners due to potential ethnic diversity. Further understanding of Halaven related&#xD;
      clinical benefit and toxicity in Asian patients through collecting clinical experience among&#xD;
      Asian countries becomes necessary and may provide better information to anticipate these&#xD;
      concerns.&#xD;
&#xD;
      The proposed &quot;Halaven Patient Registry&quot; (called the &quot;Registry&quot;) will be a patient&#xD;
      population-based registry to collect therapeutic related information from patients with&#xD;
      metastatic breast cancer who were treated with Halaven that was given as a clinical decision&#xD;
      by patient's treating physician based on clinical status of a patient and proper indication&#xD;
      of Halaven and to gain a better understanding of the use of Halaven in such Asian patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 3, 2014</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>24 months</time_frame>
    <description>he percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>24 months</time_frame>
    <description>An AE may consist of the following: A new event which was not pre-existing at initial study drug administration. A pre-existing event which recurs with increased intensity or increased frequencysubsequent to study drug administration. An event which is present at the time of study drug administration which isexacerbated following initial study drug administration.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <condition>Advanced Breast Cancer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eribulin Mesylate</intervention_name>
    <description>The patients received intravenous eribulin 1.4 mg/m2 over 2-5 minutes on days 1 and 8 of every 21 days.</description>
    <other_name>Halaven</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The advanced or metastatic breast cancer patient who received at least 1 course Halaven&#xD;
        therapy was eligible to this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An eligible patient to be entered into the Registry is defined as:&#xD;
&#xD;
               1. Patient with advanced breast cancer.&#xD;
&#xD;
               2. Halaven was given or has been treating during the period of 1 Jan 2015 to 31 Dec&#xD;
                  2016.&#xD;
&#xD;
               3. Halaven was given as single or combination.&#xD;
&#xD;
               4. Patient received at least one cycle treatment (a 21-day cycle or 2 doses) of&#xD;
                  Halaven.&#xD;
&#xD;
               5. Patient with at least 80% of the required information of the Registry CRF to be&#xD;
                  entered. It will be calculated automatically by the Registry system.&#xD;
&#xD;
                  Patient to be selected for the Registry will be based on chorological order of a&#xD;
                  patient occurred in a study center during the defined period of the Registry, if&#xD;
                  all other eligibility criteria are met.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  Those who not meet the inclusion criteria will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fang-Ming Chen, MD, PhD</last_name>
    <phone>03-3164-990</phone>
    <email>kbcs0609@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>KUN-MING RAU, MD</last_name>
      <phone>07-7317-123</phone>
      <phone_ext>3267</phone_ext>
      <email>Liu07822@ms57.hinet.net</email>
    </contact>
    <investigator>
      <last_name>KUN-MING RAU, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 13, 2017</last_update_submitted>
  <last_update_submitted_qc>August 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Undecided</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/NCT03245112
org study id: 201700596B0
nct id: NCT03245112
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
Since the first marketing authorization in the world in November 2010 granted by US FDA,
      Halaven has been approved for clinical use in more than 40 countries worldwide, including
      many Asian countries, e.g. Hong Kong, India, Japan, Malaysia, Myanmar, Philippines, South
      Korea, Singapore, Taiwan and Thailand. According to two large global phase III study reports
      of Halaven, very few Asian patients participated in these studies. In a phase II study of
      Halaven with metastatic breast cancer, the clinical efficacy and toxicity were reported only
      in 80 Japanese patients. Halaven has been granted its marketing authorization in Singapore
      since February 2011. However, most of other Asian countries including India have had the
      approval and launched from middle year of 2013 or in early 2014. Limited information of
      Halaven using in Asian patients are available except several case experience exchange
      presented by individual medical centers or as personal experience in the past. Some clinical
      concerns related to Halaven use are raised by clinicians during their clinical practice, such
      as how Halaven works on Asian patients, which type of patient obtains better clinical benefit
      from Halaven, and what are the main treatment related toxicities in Asian which may differ
      from Westerners due to potential ethnic diversity. Further understanding of Halaven related
      clinical benefit and toxicity in Asian patients through collecting clinical experience among
      Asian countries becomes necessary and may provide better information to anticipate these
      concerns.

      The proposed "Halaven Patient Registry" (called the "Registry") will be a patient
      population-based registry to collect therapeutic related information from patients with
      metastatic breast cancer who were treated with Halaven that was given as a clinical decision
      by patient's treating physician based on clinical status of a patient and proper indication
      of Halaven and to gain a better understanding of the use of Halaven in such Asian patients.
observational model: Case-Only
time perspective: Other
measure: Disease Control Rate (DCR)
time frame: 24 months
description: he percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention
measure: Number of patients with adverse events
time frame: 24 months
description: An AE may consist of the following: A new event which was not pre-existing at initial study drug administration. A pre-existing event which recurs with increased intensity or increased frequencysubsequent to study drug administration. An event which is present at the time of study drug administration which isexacerbated following initial study drug administration.
intervention type: Drug
intervention name: Eribulin Mesylate
description: The patients received intravenous eribulin 1.4 mg/m2 over 2-5 minutes on days 1 and 8 of every 21 days.
other name: Halaven
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 24 Years
maximum age: 85 Years
healthy volunteers: No
last name: Fang-Ming Chen, MD, PhD
phone: 03-3164-990
email: kbcs0609@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Undecided