<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/NCT02257775</url>
  </required_header>
  <id_info>
    <org_study_id>CCR4203</org_study_id>
    <nct_id>NCT02257775</nct_id>
  </id_info>
  <brief_title>Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer</brief_title>
  <acronym>EVOLUTION</acronym>
  <official_title>Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Cancer Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Cancer Research, United Kingdom</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to apply Whole-body DW imaging alongside the routine&#xD;
      management of patients requiring systemic therapy for metastatic breast cancer to compare the&#xD;
      time to progression of individual liver metastases within and between patients following&#xD;
      stable disease or partial response to palliative systemic therapy for breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient number of eligible and interested partients&#xD;
  </why_stopped>
  <start_date type="Actual">May 11, 2015</start_date>
  <completion_date type="Actual">November 23, 2017</completion_date>
  <primary_completion_date type="Actual">November 23, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Progression rate of liver metastases</measure>
    <time_frame>3 months</time_frame>
    <description>Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression rate of skeletal metastases</measure>
    <time_frame>3 months</time_frame>
    <description>Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global and local lesion Apparent Diffusion Coefficient (ADC) distributions of WB-DWI scans within individual patient</measure>
    <time_frame>3 months</time_frame>
    <description>Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient acceptability of WB-DWI assessed from questionnaires provided between WB-DWI scans and quantified using a 5-point Likert scale</measure>
    <time_frame>3 months</time_frame>
    <description>Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of patient acceptability to whole-body CT</measure>
    <time_frame>3 months</time_frame>
    <description>Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy</description>
  </secondary_outcome>
  <enrollment type="Actual">5</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>n/a - observational</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients requiring systemic therapy for metastatic breast cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years.&#xD;
&#xD;
          -  First metastatic breast cancer relapse after treatment for early stage disease&#xD;
&#xD;
          -  A minimum of 10 evaluable lesions in the liver on routine x-ray CT imaging&#xD;
&#xD;
          -  Patient prescribed cytotoxic, endocrine or biological therapies&#xD;
&#xD;
          -  Patient physically and psychologically fit enough to consider sequential WB-- - DWI&#xD;
             imaging alongside their standard disease monitoring&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of other cancer within the last 5 years, other than resected non-melanoma&#xD;
             skin cancer or cervical intraepithelial neoplasia&#xD;
&#xD;
          -  Diagnosis of brain metastases.&#xD;
&#xD;
          -  Contraindication to magnetic resonance MR imaging&#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>Jill Noble</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Marsden NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Royal Marsden</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>January 26, 2018</last_update_submitted>
  <last_update_submitted_qc>January 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2018</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>
  <!-- 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/NCT02257775
org study id: CCR4203
nct id: NCT02257775
lead sponsor: 
has dmc: No
The objective of this study is to apply Whole-body DW imaging alongside the routine
      management of patients requiring systemic therapy for metastatic breast cancer to compare the
      time to progression of individual liver metastases within and between patients following
      stable disease or partial response to palliative systemic therapy for breast cancer.
observational model: Case-Only
time perspective: Prospective
measure: Progression rate of liver metastases
time frame: 3 months
description: Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy
measure: Progression rate of skeletal metastases
time frame: 3 months
description: Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy
measure: Global and local lesion Apparent Diffusion Coefficient (ADC) distributions of WB-DWI scans within individual patient
time frame: 3 months
description: Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy
measure: Patient acceptability of WB-DWI assessed from questionnaires provided between WB-DWI scans and quantified using a 5-point Likert scale
time frame: 3 months
description: Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy
measure: Comparison of patient acceptability to whole-body CT
time frame: 3 months
description: Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy
intervention type: Genetic
intervention name: n/a - observational
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jill Noble
role: Principal Investigator
affiliation: Royal Marsden NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Breast Neoplasms