<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/NCT03270007</url>
  </required_header>
  <id_info>
    <org_study_id>BCP19</org_study_id>
    <nct_id>NCT03270007</nct_id>
  </id_info>
  <brief_title>Research of Intensive Treatment in Hormone Receptor&lt;10% and Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer Patients With Positive Lymph Node Residual Disease After Neoadjuvant Chemotherapy</brief_title>
  <official_title>Research of Intensive Treatment in Hormone Receptor&lt;10% and Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer Patients With Positive Lymph Node Residual Disease After Neoadjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tao OUYANG</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase IV, single-center, prospective, open-label, randomized,controlled study&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 10, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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>distant disease-free survival (DDFS)</measure>
    <time_frame>5 years after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>relapse-free survival（RFS）、overall survival（OS）</measure>
    <time_frame>5 years after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">304</enrollment>
  <condition>Primary Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vinorelbine</intervention_name>
    <description>different from primary chemotherapy(containing anthracycline or paclitaxel)</description>
    <arm_group_label>Chemotherapy</arm_group_label>
    <other_name>Intensive treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients, 18≦age ≦66 years&#xD;
&#xD;
          -  Biopsy proven lymph node positive, estrogen receptor&lt;10%、progesterone receptor &lt;10%&#xD;
             and human epidermal growth factor receptor-2 negative primary breast cancer&#xD;
&#xD;
          -  Must have completed neo-adjuvant chemotherapy with a standard regimen(containing both&#xD;
             anthracycline and paclitaxel)&#xD;
&#xD;
          -  Must have undergone surgery to remove the primary tumor by either a mastectomy or&#xD;
             enlarged local excision&#xD;
&#xD;
          -  Postoperative residual positive lymph nodes&#xD;
&#xD;
          -  Adequate recovery from recent surgery&#xD;
&#xD;
          -  No history of other malignancies&#xD;
&#xD;
          -  No currently uncontrolled diseased or active infection&#xD;
&#xD;
          -  Not pregnant or breast feeding, and on appropriate birth control if of child-bearing&#xD;
             potential&#xD;
&#xD;
          -  Adequate cardiovascular function reserve with a myocardial infarction within the past&#xD;
             six month&#xD;
&#xD;
          -  without radiotherapy and chemotherapy contraindication&#xD;
&#xD;
          -  Adequate hematologic function with:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) ≥1500/mm3&#xD;
&#xD;
               2. Platelets ≥100,000/ mm3&#xD;
&#xD;
               3. Hemoglobin ≥10 g/dL&#xD;
&#xD;
          -  Adequate hepatic and renal function with:&#xD;
&#xD;
               1. Serum bilirubin ≤1.5×UNL&#xD;
&#xD;
               2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is&#xD;
                  acceptable in the setting of hepatic metastasis)&#xD;
&#xD;
               3. BUN between 1.7 and 8.3 mmol/L&#xD;
&#xD;
               4. Cr between 40 and 110 umol/L&#xD;
&#xD;
          -  Knowledge of the investigational nature of the study and Ability to give informed&#xD;
             consent&#xD;
&#xD;
          -  Ability and willingness to comply with study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected distant metastases&#xD;
&#xD;
          -  Concurrent malignancy or history of other malignancy&#xD;
&#xD;
          -  Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months,&#xD;
             arrhythmia, unstable diabetes, hypercalcemia) or active infection&#xD;
&#xD;
          -  Geographical, social, or psychological problems that would compromise study compliance&#xD;
&#xD;
          -  Known or suspected hypersensitivity to vinorelbine&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>66 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xing Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xing Wang, MD</last_name>
    <phone>0086-10-88271119</phone>
    <phone_ext>8018</phone_ext>
    <email>wangxing_susu@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ying-jian He, MD</last_name>
    <phone>0086-10-88271119</phone>
    <phone_ext>8018</phone_ext>
    <email>mimi487@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xing Wang, MD</last_name>
      <phone>0086-10-88271119</phone>
      <phone_ext>8018</phone_ext>
      <email>wangxing_susu@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>October 26, 2020</last_update_submitted>
  <last_update_submitted_qc>October 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Tao OUYANG</investigator_full_name>
    <investigator_title>Chairman of Breast Center</investigator_title>
  </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>Vinorelbine</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/NCT03270007
org study id: BCP19
nct id: NCT03270007
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a phase IV, single-center, prospective, open-label, randomized,controlled study
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: distant disease-free survival (DDFS)
time frame: 5 years after surgery
measure: relapse-free survival（RFS）、overall survival（OS）
time frame: 5 years after surgery
arm group label: Chemotherapy
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Drug
intervention name: Vinorelbine
description: different from primary chemotherapy(containing anthracycline or paclitaxel)
arm group label: Chemotherapy
other name: Intensive treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 66 Years
healthy volunteers: No
last name: Xing Wang, MD
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Xing Wang, MD
phone: 0086-10-88271119
phone ext: 8018
email: wangxing_susu@sina.com
last name: Ying-jian He, MD
phone: 0086-10-88271119
phone ext: 8018
email: mimi487@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking University
investigator full name: Tao OUYANG
investigator title: Chairman of Breast Center
mesh term: Breast Neoplasms
mesh term: Vinorelbine