<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/NCT01662128</url>
  </required_header>
  <id_info>
    <org_study_id>xeloda</org_study_id>
    <nct_id>NCT01662128</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer</brief_title>
  <official_title>Randomized Controlled Trials of Efficacy and Safety With Xeloda as Sequential Adjuvant Therapy After Chemotherapy of Anthracycline and/or Taxane in Breast Cancer of Triple Negative or HER-2 Positive or Axillary Lymph Node Metastasis ≥4</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Select 600 cases of women with breast cancer of triple negative or Her-2 positive or with&#xD;
      more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy&#xD;
      of Anthracycline and/or Taxane. Divide them into two groups randomly. Then the experimental&#xD;
      group will be treated with Xeloda(1000mg/m2,orally,2 times/day) for six cycles (21&#xD;
      days/cycle,each taking two weeks suspending for one week) as Sequential Adjuvant Therapy. And&#xD;
      the control group will not receive any adjuvant therapy.Finally the investigators will assess&#xD;
      the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using&#xD;
      medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will select 600 cases of women with breast cancer of triple negative or&#xD;
      Her-2 positive or with more than 4 axillary lymph node metastasis. All the patients were&#xD;
      accepted the chemotherapy of Anthracycline and/or Taxane. Divide them into two groups&#xD;
      randomly. Then the experimental group will be treated with Xeloda(1000mg/m2,orally,2&#xD;
      times/day) for six cycles (21 days/cycle,each taking two weeks suspending for one week) as&#xD;
      Sequential Adjuvant Therapy. And the control group will not receive any adjuvant&#xD;
      therapy.Finally the investigators will assess the 5-year disease-free survival, 5 years and&#xD;
      10-year overall survival and safety of using medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2014</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse reactions</measure>
    <time_frame>6 months</time_frame>
    <description>The occurrence of adverse reactions and the number of cases</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>Disease-free survival of 5 years</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall survival,recurrence or death</measure>
    <time_frame>10 years</time_frame>
    <description>Overall survival,recurrence or death of 10 years</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Xeloda</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Xeloda</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xeloda</intervention_name>
    <description>Xeloda as Adjuvant Therapy</description>
    <arm_group_label>Xeloda</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Karnofsky ≥ 70&#xD;
&#xD;
          2. Provision of informed consent&#xD;
&#xD;
          3. Pathological confirmation of breast cancer and exclusion of other metastases.&#xD;
&#xD;
          4. Pathological confirmation of triple negative or Her-2 positive or with more than 4&#xD;
             axillary lymph node metastasis&#xD;
&#xD;
          5. The patients have finished the chemotherapy of Anthracycline and/or Taxane.And it's no&#xD;
             more than 28 days from accepting the last chemotherapy.&#xD;
&#xD;
          6. Laboratory criteria:&#xD;
&#xD;
        PLT ≥ 100*109/L WBC ≥ 4000/mm3 HGB ≥ 10g/dl GOT,GPT,ALP ≤ 2*ULN TBIL,DBIL,CCr ≤ 1.5*ULN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactation woman&#xD;
&#xD;
          2. Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ&#xD;
&#xD;
          3. Accepted neoadjuvant treatment including chemotherapy, radiotherapy and endocrine&#xD;
             therapy&#xD;
&#xD;
          4. History of organ transplantation&#xD;
&#xD;
          5. With mental disease&#xD;
&#xD;
          6. With severe infection or active gastrointestinal ulcers&#xD;
&#xD;
          7. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or&#xD;
             diabetes&#xD;
&#xD;
          8. Disease-free period of other malignant tumor is less than 5 years(except cured basal&#xD;
             cell skin cancer and cervical carcinoma in situ)&#xD;
&#xD;
          9. With heart disease&#xD;
&#xD;
         10. Experimental drug allergy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Zhang, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Tianjin Cancer Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tianjin Cancer Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ZHANG SHENG, DOCTOR</last_name>
      <phone>86-022-23340123</phone>
      <phone_ext>2901</phone_ext>
    </contact>
    <contact_backup>
      <last_name>ZHANG SHENG, DORTOR</last_name>
      <phone>86-022-23340123</phone>
      <phone_ext>2901</phone_ext>
    </contact_backup>
    <investigator>
      <last_name>ZHANG JIN, PROFESSOR</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 7, 2012</last_update_submitted>
  <last_update_submitted_qc>August 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tianjin Medical University</investigator_affiliation>
    <investigator_full_name>Zhang jin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <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>
  <!-- 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/NCT01662128
org study id: xeloda
nct id: NCT01662128
lead sponsor: 
has dmc: Yes
Select 600 cases of women with breast cancer of triple negative or Her-2 positive or with
      more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy
      of Anthracycline and/or Taxane. Divide them into two groups randomly. Then the experimental
      group will be treated with Xeloda(1000mg/m2,orally,2 times/day) for six cycles (21
      days/cycle,each taking two weeks suspending for one week) as Sequential Adjuvant Therapy. And
      the control group will not receive any adjuvant therapy.Finally the investigators will assess
      the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using
      medications.
The investigators will select 600 cases of women with breast cancer of triple negative or
      Her-2 positive or with more than 4 axillary lymph node metastasis. All the patients were
      accepted the chemotherapy of Anthracycline and/or Taxane. Divide them into two groups
      randomly. Then the experimental group will be treated with Xeloda(1000mg/m2,orally,2
      times/day) for six cycles (21 days/cycle,each taking two weeks suspending for one week) as
      Sequential Adjuvant Therapy. And the control group will not receive any adjuvant
      therapy.Finally the investigators will assess the 5-year disease-free survival, 5 years and
      10-year overall survival and safety of using medications.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse reactions
time frame: 6 months
description: The occurrence of adverse reactions and the number of cases
measure: Disease-free survival
time frame: 5 years
description: Disease-free survival of 5 years
measure: Overall survival,recurrence or death
time frame: 10 years
description: Overall survival,recurrence or death of 10 years
arm group label: Xeloda
arm group type: Experimental
description: Xeloda
intervention type: Drug
intervention name: Xeloda
description: Xeloda as Adjuvant Therapy
arm group label: Xeloda
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jin Zhang, Professor
role: Study Chair
affiliation: Tianjin Cancer Hospital
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tianjin Medical University
investigator full name: Zhang jin
investigator title: Professor
mesh term: Breast Neoplasms
mesh term: Capecitabine