<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/NCT02207361</url>
  </required_header>
  <id_info>
    <org_study_id>CIH-TZS-20140421-02</org_study_id>
    <nct_id>NCT02207361</nct_id>
  </id_info>
  <brief_title>Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer</brief_title>
  <official_title>A Randomized Prospective Clinical Trial of Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin as First-Line Treatment in 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>
      Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National&#xD;
      Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is&#xD;
      also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Randomized Prospective Clinical Trial of Paclitaxel in Combination with Carboplatin Versus&#xD;
      Paclitaxel plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer. The primary&#xD;
      endpoints of the study is progression free survival (PFS). The secondary endpoints are&#xD;
      overall response rate (ORR), overall survival (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 4</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>Paclitaxel, Carboplatin，injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paclitaxel, Epirubicin，injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel, Carboplatin</intervention_name>
    <description>Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.</description>
    <arm_group_label>Paclitaxel, Carboplatin，injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel, Epirubicin</intervention_name>
    <description>Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.</description>
    <arm_group_label>Paclitaxel, Epirubicin，injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female ≥ 18 years old, ECOG 0-2 or KPS≥60, Expected lifetime more than 12 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, Paclitaxel, platinum and anthracycline-based drugs' allergy, Severe&#xD;
             Infection.&#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>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>
    </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>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Epirubicin</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/NCT02207361
org study id: CIH-TZS-20140421-02
nct id: NCT02207361
lead sponsor: 
has dmc: Yes
Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National
      Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is
      also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.
A Randomized Prospective Clinical Trial of Paclitaxel in Combination with Carboplatin Versus
      Paclitaxel plus Epirubicin as First-Line Treatment in 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: Paclitaxel, Carboplatin，injection
arm group type: Experimental
description: Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.
arm group label: Paclitaxel, Epirubicin，injection
arm group type: Active Comparator
description: Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.
intervention type: Drug
intervention name: Paclitaxel, Carboplatin
description: Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.
arm group label: Paclitaxel, Carboplatin，injection
intervention type: Drug
intervention name: Paclitaxel, Epirubicin
description: Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.
arm group label: Paclitaxel, Epirubicin，injection
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
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: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Carboplatin
mesh term: Epirubicin