<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/NCT03017404</url>
  </required_header>
  <id_info>
    <org_study_id>CSPC-DMS-BC-02</org_study_id>
    <nct_id>NCT03017404</nct_id>
  </id_info>
  <brief_title>A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer</brief_title>
  <official_title>A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection in Neoadjuvant Chemotherapy for Patients With Locally Advanced Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hebei Medical University Fourth Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hebei Medical University Fourth Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection&#xD;
      combination with cyclophosphamide and sequential treatment of docetaxel for patients with&#xD;
      locally advanced breast cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</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>maximum tolerated dose</measure>
    <time_frame>4 cycles (each cycle is 21 days) of chemotherapy</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>treatment group:35 mg/m(2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>treatment group:40 mg/m(2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>treatment group:45 mg/m(2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>treatment group:50 mg/m(2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxorubicin Hydrochloride Liposome Injection</intervention_name>
    <arm_group_label>treatment group:35 mg/m(2)</arm_group_label>
    <arm_group_label>treatment group:40 mg/m(2)</arm_group_label>
    <arm_group_label>treatment group:45 mg/m(2)</arm_group_label>
    <arm_group_label>treatment group:50 mg/m(2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <arm_group_label>treatment group:35 mg/m(2)</arm_group_label>
    <arm_group_label>treatment group:40 mg/m(2)</arm_group_label>
    <arm_group_label>treatment group:45 mg/m(2)</arm_group_label>
    <arm_group_label>treatment group:50 mg/m(2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>docetaxel</intervention_name>
    <arm_group_label>treatment group:35 mg/m(2)</arm_group_label>
    <arm_group_label>treatment group:40 mg/m(2)</arm_group_label>
    <arm_group_label>treatment group:45 mg/m(2)</arm_group_label>
    <arm_group_label>treatment group:50 mg/m(2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients newly diagnosed breast cancer≥18 and ≤70 years of age;&#xD;
&#xD;
          -  Karnofsky performance status≥70 and measurable or evaluable;&#xD;
&#xD;
          -  Stages Ⅲa-ⅢC;&#xD;
&#xD;
          -  Baseline left ventricular ejection fraction (LVEF) ≥ 50%;&#xD;
&#xD;
          -  Adequate marrow function (WBC count&gt; 4.0×10(9)/L, neutrophil&gt; 2.0×10(9)/L, platelet&#xD;
             count &gt; 100×10(9)/L，hemoglobin &gt; 90g/L );&#xD;
&#xD;
          -  AST and ALT ≤1.5× institutional upper limit of normal, alkaline phosphatase&#xD;
&#xD;
          -  ≤2.5×institutional upper limit of normal，bilirubin ≤institutional upper limit of&#xD;
             normal;&#xD;
&#xD;
          -  Serum creatinine ≥ 44µmol/L and ≤ 133 µmol/L;&#xD;
&#xD;
          -  Expected lifetime ≥ 12 months;&#xD;
&#xD;
          -  Pregnancy tests of reproductive age women is negative;&#xD;
&#xD;
          -  All patients provided written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Distant metastasis;&#xD;
&#xD;
          -  Severe heart failure (NYHA grade II or higher);&#xD;
&#xD;
          -  Active and uncontrolled severe infection;&#xD;
&#xD;
          -  Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity&#xD;
             reactions to products containing liposomal doxorubicin and docetaxel;&#xD;
&#xD;
          -  Have accepted any other anti-tumor drug within 30 days before the first dose of&#xD;
             doxorubicin hydrochloride liposome or doxorubicin;&#xD;
&#xD;
          -  Pregnancy or breast feeding;&#xD;
&#xD;
          -  Other situations that investigators consider as contra-indication for this study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fourth Hospital of Hebei Medical University</name>
      <address>
        <city>Shi Jiazhuang</city>
        <state>Hebei</state>
        <zip>050019</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</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>Cyclophosphamide</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</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/NCT03017404
org study id: CSPC-DMS-BC-02
nct id: NCT03017404
lead sponsor: 
has dmc: No
To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection
      combination with cyclophosphamide and sequential treatment of docetaxel for patients with
      locally advanced breast cancer
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: maximum tolerated dose
time frame: 4 cycles (each cycle is 21 days) of chemotherapy
arm group label: treatment group:35 mg/m(2)
arm group type: Experimental
description: Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
arm group label: treatment group:40 mg/m(2)
arm group type: Experimental
description: Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
arm group label: treatment group:45 mg/m(2)
arm group type: Experimental
description: Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
arm group label: treatment group:50 mg/m(2)
arm group type: Experimental
description: Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
intervention type: Drug
intervention name: Doxorubicin Hydrochloride Liposome Injection
arm group label: treatment group:35 mg/m(2)
arm group label: treatment group:40 mg/m(2)
arm group label: treatment group:45 mg/m(2)
arm group label: treatment group:50 mg/m(2)
intervention type: Drug
intervention name: Cyclophosphamide
arm group label: treatment group:35 mg/m(2)
arm group label: treatment group:40 mg/m(2)
arm group label: treatment group:45 mg/m(2)
arm group label: treatment group:50 mg/m(2)
intervention type: Drug
intervention name: docetaxel
arm group label: treatment group:35 mg/m(2)
arm group label: treatment group:40 mg/m(2)
arm group label: treatment group:45 mg/m(2)
arm group label: treatment group:50 mg/m(2)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Cyclophosphamide
mesh term: Docetaxel
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin