<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/NCT04429633</url>
  </required_header>
  <id_info>
    <org_study_id>2018-11-128</org_study_id>
    <nct_id>NCT04429633</nct_id>
  </id_info>
  <brief_title>Strain vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention in Breast Cancer</brief_title>
  <official_title>Strain-based vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention Strategy in Patients With Breast Cancer Who Treated With Adjuvant Trastuzumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparing preventive effect of myocardial global longitudinal strain-based cardioprotective&#xD;
      stragety (angiotensin receptor blocker prophylaxis) with left ventricular ejection&#xD;
      fraction-based strategy in breast cancer patients treated with adjuvant trastuzumab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the left ventricular global longitudinal strain (GLS) enables early prediction of&#xD;
      trastuzumab-related cardiomyopathy, its clinical application has been hampered due to the&#xD;
      lack of appropriate evaluation and treatment strategies. Therefore, we aimed to evaluate the&#xD;
      effect of early intervention strategy (GLS-based cardiotoxicity monitoring and administration&#xD;
      of candesartan) by comparing with conventional intervention strategy (left ventricular&#xD;
      ejection fraction-based cardiotoxicity monitoring and administration of candesartan) in&#xD;
      breast cancer patients who treated with adjuvant trastuzumab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 19, 2019</start_date>
  <completion_date type="Anticipated">July 18, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 18, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Left ventricular ejection fraction (LVEF)</measure>
    <time_frame>at months 3,6,9,12,18</time_frame>
    <description>Maximum change in LVEF</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overt chemotherapy induced cardiotoxicity</measure>
    <time_frame>any time</time_frame>
    <description>LVEF &lt; 45%, decline in LVEF by &gt;10% to a value to 45-49%, symptomatic congestive heart failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cardiac biomarker</measure>
    <time_frame>at months 3,6,9,12,18</time_frame>
    <description>NT-pro BNP, cardiac troponin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">136</enrollment>
  <condition>Cardiotoxicity</condition>
  <condition>Breast Cancer</condition>
  <condition>Prevention</condition>
  <condition>Adjuvant</condition>
  <condition>Trastuzumab</condition>
  <arm_group>
    <arm_group_label>Conventional Cardiac intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Starting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Cardiac intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Starting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Candesartan</intervention_name>
    <description>If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication.</description>
    <arm_group_label>Conventional Cardiac intervention</arm_group_label>
    <arm_group_label>Early Cardiac intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female aged ≥ 18 years&#xD;
&#xD;
          -  Pathologically confirmed HER2-positive breast cancer&#xD;
&#xD;
          -  Adjuvant treatment plan comprises at least 12 cycles of Trastuzumab&#xD;
&#xD;
          -  Baseline echocardiogram should be performed before starting trastuzumab&#xD;
&#xD;
          -  Cumulative anthracycline dose ≤ 300mg/m2&#xD;
&#xD;
          -  Written informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity or alllergic reaction to the study medication&#xD;
&#xD;
          -  Metastatic breast cancer&#xD;
&#xD;
          -  Treatment with angiotensin converting enzyme(ACE) inhibitor , Angiotensin receptor&#xD;
             blocker (ARB), beta-blocking agents, or diuretics&#xD;
&#xD;
          -  Patients with NCI/CTCAE grade ≥ 2 congestive heart failure, myocardial infarction,&#xD;
             symptomatic left ventricular systolic dysfunction, heart's valve disease (≥ moderate),&#xD;
             arrhythmias (Grade ≥ 3) &lt; 12 months before enrollment&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Baseline systolic pressure &lt; 90mmHg&#xD;
&#xD;
          -  Cumulative anthracycline dose &gt; 300mg/m2&#xD;
&#xD;
          -  Serious concurrent illness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yeon Hee Park, MD, PhD</last_name>
    <phone>+82-2-3410-3450</phone>
    <email>yeonh.park@samsung.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yeon Hee Park, MD, Ph.D</last_name>
      <phone>+82-2-3410-3459</phone>
      <email>yeonh.park@samsung.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Yeon Hee Park</investigator_full_name>
    <investigator_title>Professor, MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Cardiotoxicity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candesartan</mesh_term>
    <mesh_term>Candesartan cilexetil</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04429633
org study id: 2018-11-128
nct id: NCT04429633
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Comparing preventive effect of myocardial global longitudinal strain-based cardioprotective
      stragety (angiotensin receptor blocker prophylaxis) with left ventricular ejection
      fraction-based strategy in breast cancer patients treated with adjuvant trastuzumab.
Despite the left ventricular global longitudinal strain (GLS) enables early prediction of
      trastuzumab-related cardiomyopathy, its clinical application has been hampered due to the
      lack of appropriate evaluation and treatment strategies. Therefore, we aimed to evaluate the
      effect of early intervention strategy (GLS-based cardiotoxicity monitoring and administration
      of candesartan) by comparing with conventional intervention strategy (left ventricular
      ejection fraction-based cardiotoxicity monitoring and administration of candesartan) in
      breast cancer patients who treated with adjuvant trastuzumab.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Left ventricular ejection fraction (LVEF)
time frame: at months 3,6,9,12,18
description: Maximum change in LVEF
measure: Overt chemotherapy induced cardiotoxicity
time frame: any time
description: LVEF < 45%, decline in LVEF by >10% to a value to 45-49%, symptomatic congestive heart failure
measure: Changes in cardiac biomarker
time frame: at months 3,6,9,12,18
description: NT-pro BNP, cardiac troponin
arm group label: Conventional Cardiac intervention
arm group type: Active Comparator
description: Starting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram.
arm group label: Early Cardiac intervention
arm group type: Active Comparator
description: Starting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram.
intervention type: Drug
intervention name: Candesartan
description: If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication.
arm group label: Conventional Cardiac intervention
arm group label: Early Cardiac intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yeon Hee Park, MD, PhD
phone: +82-2-3410-3450
email: yeonh.park@samsung.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Yeon Hee Park
investigator title: Professor, MD, PhD
mesh term: Breast Neoplasms
mesh term: Cardiotoxicity
mesh term: Candesartan
mesh term: Candesartan cilexetil