<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/NCT01725386</url>
  </required_header>
  <id_info>
    <org_study_id>ML25640</org_study_id>
    <nct_id>NCT01725386</nct_id>
  </id_info>
  <brief_title>An Observational Study of Xeloda (Capecitabine) in Participants With Metastatic or Advanced Breast Cancer</brief_title>
  <acronym>XEPAD</acronym>
  <official_title>Study on Xeloda® to Document Its Use in Routine Practice in Patients With Metastatic or Advanced 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 observational study will evaluate the routine clinical use and the safety and efficacy&#xD;
      of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer. Eligible&#xD;
      participants will be followed for up to 24 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Receiving Concomitant Medications During the Study</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Relevant Medical History Assessed at Baseline</measure>
    <time_frame>Day 1</time_frame>
    <description>To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline</measure>
    <time_frame>Day 1</time_frame>
    <description>To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Survival Time</measure>
    <time_frame>Up to approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events</measure>
    <time_frame>Up to approximately 4 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">274</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Monotherapy</arm_group_label>
    <description>Capecitabine as monotherapy according to prescribing information and normal clinical practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Therapy</arm_group_label>
    <description>Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Oral tablet(s) administered according to prescribing information</description>
    <arm_group_label>Combination Therapy</arm_group_label>
    <arm_group_label>Monotherapy</arm_group_label>
    <other_name>XELODA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with metastatic breast cancer initiated on therapy with capecitabine&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult female participants, &gt;/= 18 years of age&#xD;
&#xD;
          -  Cytologic/histopathologic confirmed diagnosis of metastatic breast cancer&#xD;
&#xD;
          -  Prescribed capecitabine as in routine clinical practice&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in any other clinical trial&#xD;
&#xD;
          -  History of severe and unexpected reactions to fluoropyrimidine therapy&#xD;
&#xD;
          -  Hypersensitivity to capecitabine or to any of the excipients of fluorouracil&#xD;
&#xD;
          -  Known dihydropyrimidine dehydrogenase (DPD) deficiency&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Severe leucopenia, neutropenia, or thrombocytopenia&#xD;
&#xD;
          -  Severe hepatic impairment&#xD;
&#xD;
          -  Severe renal impairment (creatinine clearance below 30 ml/min)&#xD;
&#xD;
          -  Treatment with sorivudine or its chemically related analogues, such as brivudine&#xD;
&#xD;
          -  Refusal to give consent&#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_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Abbottabad</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Faisalabad</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gujranwala</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hyderabad</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Islamabad</city>
        <zip>44000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Islamabad</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Karachi</city>
        <zip>74700</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Karachi</city>
        <zip>75500</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lahore</city>
        <zip>54600</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lahore</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multan</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Peshwar</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rawalpindi</city>
        <zip>46000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rawalpindi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <results_first_submitted>June 30, 2016</results_first_submitted>
  <results_first_submitted_qc>June 30, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 12, 2016</results_first_posted>
  <last_update_submitted>August 19, 2016</last_update_submitted>
  <last_update_submitted_qc>August 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 28, 2016</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>274 participants were enrolled in the study; of these, 23 participants from 3 centers were excluded from the analysis due to study termination at those 3 centers. The remaining 251 participants were eligible for analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Monotherapy</title>
          <description>Capecitabine (XELODA®) as monotherapy according to prescribing information and normal clinical practice.</description>
        </group>
        <group group_id="P2">
          <title>Combination Therapy</title>
          <description>Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="188"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="175"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).</population>
      <group_list>
        <group group_id="B1">
          <title>Monotherapy</title>
          <description>Capecitabine as monotherapy according to prescribing information and normal clinical practice.</description>
        </group>
        <group group_id="B2">
          <title>Combination Therapy</title>
          <description>Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="188"/>
            <count group_id="B2" value="63"/>
            <count group_id="B3" value="251"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.00" spread="12.35"/>
                    <measurement group_id="B2" value="45.00" spread="15.19"/>
                    <measurement group_id="B3" value="47.00" spread="12.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="188"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="251"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy</title>
        <description>To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.</description>
        <time_frame>Up to approximately 4 years</time_frame>
        <population>Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).</population>
        <group_list>
          <group group_id="O1">
            <title>Monotherapy</title>
            <description>Capecitabine as monotherapy according to prescribing information and normal clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Combination Therapy</title>
            <description>Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy</title>
          <description>To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.</description>
          <population>Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="188"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First Line</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6"/>
                    <measurement group_id="O2" value="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second Line</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.8"/>
                    <measurement group_id="O2" value="41.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Third Line</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6"/>
                    <measurement group_id="O2" value="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Receiving Concomitant Medications During the Study</title>
        <description>Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.</description>
        <time_frame>Up to approximately 4 years</time_frame>
        <population>Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).</population>
        <group_list>
          <group group_id="O1">
            <title>Monotherapy</title>
            <description>Capecitabine as monotherapy according to prescribing information and normal clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Combination Therapy</title>
            <description>Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Receiving Concomitant Medications During the Study</title>
          <description>Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.</description>
          <population>Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="188"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5"/>
                    <measurement group_id="O2" value="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Relevant Medical History Assessed at Baseline</title>
        <description>To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.</description>
        <time_frame>Day 1</time_frame>
        <population>Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).</population>
        <group_list>
          <group group_id="O1">
            <title>Monotherapy</title>
            <description>Capecitabine as monotherapy according to prescribing information and normal clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Combination Therapy</title>
            <description>Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Relevant Medical History Assessed at Baseline</title>
          <description>To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.</description>
          <population>Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="188"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>History of Other Types of Cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family History of Breast Cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                    <measurement group_id="O2" value="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>History of Co-morbidities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1"/>
                    <measurement group_id="O2" value="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Premenopausal Status</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.8"/>
                    <measurement group_id="O2" value="41.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postmenopausal Status</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.2"/>
                    <measurement group_id="O2" value="58.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline</title>
        <description>To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized.</description>
        <time_frame>Day 1</time_frame>
        <population>Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).</population>
        <group_list>
          <group group_id="O1">
            <title>Monotherapy</title>
            <description>Capecitabine as monotherapy according to prescribing information and normal clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Combination Therapy</title>
            <description>Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline</title>
          <description>To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized.</description>
          <population>Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="188"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Moderately Differentiated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.6"/>
                    <measurement group_id="O2" value="42.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Well Differentiated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0"/>
                    <measurement group_id="O2" value="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poorly Differentiated/Undifferentiated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.4"/>
                    <measurement group_id="O2" value="46.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Survival Time</title>
        <time_frame>Up to approximately 4 years</time_frame>
        <population>Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).</population>
        <group_list>
          <group group_id="O1">
            <title>Monotherapy</title>
            <description>Capecitabine as monotherapy according to prescribing information and normal clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Combination Therapy</title>
            <description>Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Survival Time</title>
          <population>Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).</population>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="188"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.493" lower_limit="14.169" upper_limit="16.817"/>
                    <measurement group_id="O2" value="15.417" lower_limit="13.512" upper_limit="17.322"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.895</p_value>
            <method>Log Rank (Mantel-Cox)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Adverse Events</title>
        <time_frame>Up to approximately 4 years</time_frame>
        <population>Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).</population>
        <group_list>
          <group group_id="O1">
            <title>Monotherapy</title>
            <description>Capecitabine as monotherapy according to prescribing information and normal clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Combination Therapy</title>
            <description>Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events</title>
          <population>Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="188"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.2"/>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 4 years</time_frame>
      <desc>Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).</desc>
      <group_list>
        <group group_id="E1">
          <title>Monotherapy</title>
          <description>Capecitabine as monotherapy according to prescribing information and normal clinical practice.</description>
        </group>
        <group group_id="E2">
          <title>Combination Therapy</title>
          <description>Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (11.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="85" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiopulmonary Arrest</sub_title>
                <counts group_id="E1" subjects_affected="66" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Vomitting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Melena</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Hematemesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Head Ache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Body Ache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>High grade fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Diabetic Coma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Semi conscous/Unconsciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Multiple Organ Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatorenal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Hepatic Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Hepatic failure with Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cerebral Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pyogenic Meningitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Septicemia &amp; Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Infected chest wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in sternum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Disease Progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Generalized Fits</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Excessive bleeding from Right breast mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Nodules on Right chest &amp; Axilla</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Shortness of breath</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Respiratory Distress/Failure</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Aspiration Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Chest Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin cutaneous Infiltration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (11.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="73" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Peripheral edema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Hand-and-Foot Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="188"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800 821-8590</phone>
      <email>genentech@druginfo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01725386
org study id: ML25640
nct id: NCT01725386
lead sponsor: 
This observational study will evaluate the routine clinical use and the safety and efficacy
      of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer. Eligible
      participants will be followed for up to 24 months.
observational model: Cohort
time perspective: Prospective
measure: Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
time frame: Up to approximately 4 years
description: To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.
measure: Percentage of Participants Receiving Concomitant Medications During the Study
time frame: Up to approximately 4 years
description: Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.
measure: Percentage of Participants With Relevant Medical History Assessed at Baseline
time frame: Day 1
description: To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.
measure: Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline
time frame: Day 1
description: To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized.
measure: Mean Survival Time
time frame: Up to approximately 4 years
measure: Percentage of Participants With Adverse Events
time frame: Up to approximately 4 years
arm group label: Monotherapy
description: Capecitabine as monotherapy according to prescribing information and normal clinical practice.
arm group label: Combination Therapy
description: Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
intervention type: Drug
intervention name: Capecitabine
description: Oral tablet(s) administered according to prescribing information
arm group label: Combination Therapy
arm group label: Monotherapy
other name: XELODA
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Pakistan
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Capecitabine
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 