<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/NCT01661153</url>
  </required_header>
  <id_info>
    <org_study_id>ML25312</org_study_id>
    <nct_id>NCT01661153</nct_id>
  </id_info>
  <brief_title>An Observational Study of Avastin (Bevacizumab) in Combination With Paclitaxel in First-Line Treatment in Patients With HER2-Negative Metastatic Breast Cancer</brief_title>
  <official_title>A Non-interventional Study of Avastin in Combination With Paclitaxel for First Line Treatment in HER2 Negative Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This prospective observational study will evaluate the use in clinical practice, efficacy and&#xD;
      safety of Avastin (bevacizumab) in combination with paclitaxel in first line in patients with&#xD;
      HER2-negative metastatic breast cancer. Data will be collected from eligible patients for up&#xD;
      to 2.5 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2011</start_date>
  <completion_date type="Actual">September 14, 2016</completion_date>
  <primary_completion_date type="Actual">September 14, 2016</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>Progression-free survival</measure>
    <time_frame>approximately 2.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dosage/schedule/number of cycles of Avastin treatment in clinical practice</measure>
    <time_frame>approximately 2.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>approximately 2.5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        HER2-negative breast cancer patients in first-line treatment of metastatic disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Locally recurrent or metastatic breast cancer&#xD;
&#xD;
          -  No prior treatment for metastatic or locally recurrent disease&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or clinical evidence of brain metastases&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Uncontrolled hypertension ( systolic &gt; 150 mmHg and/or diastolic &gt; 100 mmHg) or&#xD;
             clinically significant (i.e. active) cardiovascular disease&#xD;
&#xD;
          -  Major surgical procedure or significant traumatic injury within 28 days prior to&#xD;
             enrolment&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uni Hospital Split; Oncology &amp; Radiotherapy</name>
      <address>
        <city>Split</city>
        <zip>21000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Varazdin</name>
      <address>
        <city>Varazdin</city>
        <zip>42000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 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>
  <!-- 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/NCT01661153
org study id: ML25312
nct id: NCT01661153
lead sponsor: 
This prospective observational study will evaluate the use in clinical practice, efficacy and
      safety of Avastin (bevacizumab) in combination with paclitaxel in first line in patients with
      HER2-negative metastatic breast cancer. Data will be collected from eligible patients for up
      to 2.5 years.
observational model: Cohort
time perspective: Prospective
measure: Progression-free survival
time frame: approximately 2.5 years
measure: Dosage/schedule/number of cycles of Avastin treatment in clinical practice
time frame: approximately 2.5 years
measure: Safety: Incidence of adverse events
time frame: approximately 2.5 years
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
country: Croatia
responsible party type: Sponsor
mesh term: Breast Neoplasms