<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/NCT02207335</url>
  </required_header>
  <id_info>
    <org_study_id>CIH-TZS-20140421-01</org_study_id>
    <nct_id>NCT02207335</nct_id>
  </id_info>
  <brief_title>Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer</brief_title>
  <official_title>A Multicenter Randomized Phase Ⅲ Clinical Trial of Gemcitabine in Combination With Capecitabine Versus Gemcitabine Plus Carboplatin as First-line Treatment in Triple-negative Recurrent or Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University Cancer Institute and Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme&#xD;
      in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with&#xD;
      capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with&#xD;
      small sample.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multicenter randomized phase Ⅲ clinical trial of gemcitabine in combination with&#xD;
      capecitabine versus gemcitabine plus carboplatin as first-line treatment in triple-negative&#xD;
      recurrent or metastatic breast cancer.The primary endpoints of the study is progression free&#xD;
      survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival&#xD;
      (OS) and safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">November 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>RECIST 1.1</measure>
    <time_frame>-7 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Gemcitabine，Capecitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gemcitabine, Carboplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine，Capecitabine</intervention_name>
    <description>Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14</description>
    <arm_group_label>Gemcitabine，Capecitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine, Carboplatin</intervention_name>
    <description>Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8</description>
    <arm_group_label>Gemcitabine, Carboplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  18-70 years old&#xD;
&#xD;
          -  ECOG 0-1&#xD;
&#xD;
          -  Expected lifetime more than 12 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Brain Metastasis,&#xD;
&#xD;
          -  Severe Infection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhongsheng Tong, Master</last_name>
    <role>Study Director</role>
    <affiliation>Tianjin Medical University Cancer Institute and Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhongsheng Tong, Master</last_name>
    <phone>+86 18622221181</phone>
    <email>18622221181@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300061</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhongsheng Tong, Master</last_name>
      <phone>+86 18622221181</phone>
      <email>18622221181@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>April 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>December 21, 2015</last_update_submitted>
  <last_update_submitted_qc>December 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2015</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>Carboplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <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/NCT02207335
org study id: CIH-TZS-20140421-01
nct id: NCT02207335
lead sponsor: 
has dmc: Yes
Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme
      in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with
      capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with
      small sample.
A multicenter randomized phase Ⅲ clinical trial of gemcitabine in combination with
      capecitabine versus gemcitabine plus carboplatin as first-line treatment in triple-negative
      recurrent or metastatic breast cancer.The primary endpoints of the study is progression free
      survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival
      (OS) and safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: RECIST 1.1
time frame: -7 days
arm group label: Gemcitabine，Capecitabine
arm group type: Experimental
description: Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14
arm group label: Gemcitabine, Carboplatin
arm group type: Active Comparator
description: Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8
intervention type: Drug
intervention name: Gemcitabine，Capecitabine
description: Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14
arm group label: Gemcitabine，Capecitabine
intervention type: Drug
intervention name: Gemcitabine, Carboplatin
description: Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8
arm group label: Gemcitabine, Carboplatin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Zhongsheng Tong, Master
role: Study Director
affiliation: Tianjin Medical University Cancer Institute and Hospital
last name: Zhongsheng Tong, Master
phone: +86 18622221181
email: 18622221181@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Carboplatin
mesh term: Gemcitabine
mesh term: Capecitabine