<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/NCT01715155</url>
  </required_header>
  <id_info>
    <org_study_id>NIS-OBG-XXX-2012/1</org_study_id>
    <nct_id>NCT01715155</nct_id>
  </id_info>
  <brief_title>Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study</brief_title>
  <official_title>A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the incidence rate of progression of disease, to&#xD;
      describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in&#xD;
      the clinical practice in Bulgaria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in&#xD;
      Clinical Practice in Bulgaria&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of progression events on a per patient-year-basis</measure>
    <time_frame>Up to 2 years 5 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients among study population who have not progressed at 12 and 18 months after they were diagnosed</measure>
    <time_frame>Up to 2 years 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median and mean time interval that elapsed between diagnosis and first objective tumor progression (TTP) event and subsequent events</measure>
    <time_frame>Up to 2 years 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median and mean time from the date of diagnosis to the date of breast cancer progression or death whichever occurred first</measure>
    <time_frame>Up to 2 years 5 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">171</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Female patients diagnosed with metastatic breast cancer</arm_group_label>
    <description>Patients newly diagnosed with metastatic breast cancer, either De Novo or having progressed from a non-metastatic stage.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients newly diagnosed with breast cancer (according to ICD-10) with confirmed&#xD;
        metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic&#xD;
        stage.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New diagnosis of breast cancer according to ICD-10 with confirmed metastasis&#xD;
&#xD;
          -  Confirmed diagnosis between 1st July 2010 and 30th June 2011.&#xD;
&#xD;
          -  Female patient managed for her disease at the same setting where final diagnosis of&#xD;
             MBC was performed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of concurrent or other primary malignancies (except curatively resected&#xD;
             non-melanoma skin cancer or in situ cervical cancer).&#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>Research Site</name>
      <address>
        <city>Pleven</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ruse</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stara Zagora</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reaseach Site</name>
      <address>
        <city>Varna</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>August 21, 2013</last_update_submitted>
  <last_update_submitted_qc>August 21, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metastatic Breast Cancer,</keyword>
  <keyword>retrospective study,</keyword>
  <keyword>disease progression,</keyword>
  <keyword>clinical management</keyword>
  <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/NCT01715155
org study id: NIS-OBG-XXX-2012/1
nct id: NCT01715155
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the incidence rate of progression of disease, to
      describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in
      the clinical practice in Bulgaria.
A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in
      Clinical Practice in Bulgaria
observational model: Cohort
time perspective: Retrospective
measure: Number of progression events on a per patient-year-basis
time frame: Up to 2 years 5 months
measure: Proportion of patients among study population who have not progressed at 12 and 18 months after they were diagnosed
time frame: Up to 2 years 5 months
measure: Median and mean time interval that elapsed between diagnosis and first objective tumor progression (TTP) event and subsequent events
time frame: Up to 2 years 5 months
measure: Median and mean time from the date of diagnosis to the date of breast cancer progression or death whichever occurred first
time frame: Up to 2 years 5 months
arm group label: Female patients diagnosed with metastatic breast cancer
description: Patients newly diagnosed with metastatic breast cancer, either De Novo or having progressed from a non-metastatic stage.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Bulgaria
responsible party type: Sponsor
mesh term: Breast Neoplasms