<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/NCT01660542</url>
  </required_header>
  <id_info>
    <org_study_id>4-2011-0068</org_study_id>
    <nct_id>NCT01660542</nct_id>
  </id_info>
  <brief_title>An Open-label, Multi-center Phase Ⅳ Trial to Evaluate the Efficacy and Safety of Sequential Neoadjuvant Chemotherapy With Docetaxel(Monotaxel®) After Doxorubicin Plus Cyclophosphamide Combination Chemotherapy in Locally Advanced Breast Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of&#xD;
      sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by&#xD;
      4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or&#xD;
      cytologically confirmed axillary lymph nodes metastasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 4</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>Pathologic Complete Response</measure>
    <time_frame>26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens</time_frame>
    <description>Pathologic complete response is defined as the disappearance of all invasive cancer in the postsurgical breast and lymph node specimens after completion of neoadjuvant chemotherapy. Only residual intraductal carcinoma in the postsurgical breast specimen after neoadjuvant chemotherapy is also considered as the achievement of pathologic complete response.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Locally Advanced Breast Cancer</condition>
  <arm_group>
    <arm_group_label>doxorubicin/cyclophosphamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neoadjuvant Chemotherapy with Docetaxel(Monotaxel®) after Doxorubicin plus Cyclophosphamide</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neoadjuvant Chemotherapy with Docetaxel</intervention_name>
    <description>Doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (day 1), IV (in the vein), every 21 days, a total of 4 cycles -&gt; Docetaxel 100 mg/m2 (day 1) IV, every 21 days, a total of 4 cycles</description>
    <arm_group_label>doxorubicin/cyclophosphamide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with histologically proven invasive breast cancer - the primary tumor size is&#xD;
             at least 5cm or cytologically proven axillary node metastasis&#xD;
&#xD;
          2. no evidence of systemic metastasis pathologically or radiologically&#xD;
&#xD;
          3. age at the time of diagnosis between 20 and 70 years&#xD;
&#xD;
          4. patients with previously untreated primary breast cancer including chemotherapy&#xD;
&#xD;
          5. general performance status with ECOG 0-2&#xD;
&#xD;
          6. sufficient hematopoietic function (absolute neutrophil count of ≥ 1,500/mm3, platelet&#xD;
             count of ≥ 100,000/mm3, and hemoglobin of ≥ 10 g/dL)&#xD;
&#xD;
          7. sufficient renal function (serum creatinine level of ≤ 1.5 mg/dL)&#xD;
&#xD;
          8. sufficient liver function (total serum bilirubin level ≤ 1.5 times the upper normal&#xD;
             limit; serum AST and ALT levels ≤ 1.5 times the upper normal limit; and serum alkaline&#xD;
             phosphatase level ≤ 1.5 times the upper normal limit)&#xD;
&#xD;
          9. sufficient cardiac function (normal electrocardiography within 1 month or LVEF&gt;50% by&#xD;
             echocardiography or MUGA scan within 3 months)&#xD;
&#xD;
         10. patients who agree to enroll this clinical trial and sign the written informed consent&#xD;
             voluntarily&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients with evidence of distant metastases&#xD;
&#xD;
          2. patients with other previous malignancy except breast cancer&#xD;
&#xD;
          3. pregnant (positive hCG test 1 week before registration) or lactating patient&#xD;
&#xD;
          4. uncontrolled serious infection&#xD;
&#xD;
          5. patients with psychiatric disease or epilepsy&#xD;
&#xD;
          6. patients with clinically severe cardiac disease within 6 months such as atrial or&#xD;
             ventricular arrhythmia, congestive heart failure, myocardial infarction, or unstable&#xD;
             angina&#xD;
&#xD;
          7. male breast cancer&#xD;
&#xD;
          8. patients with poor general condition who are not able to understand or sign the&#xD;
             written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 5, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>October 30, 2016</last_update_submitted>
  <last_update_submitted_qc>October 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2016</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>Docetaxel</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/NCT01660542
org study id: 4-2011-0068
nct id: NCT01660542
lead sponsor: 
has dmc: No
This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of
      sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by
      4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or
      cytologically confirmed axillary lymph nodes metastasis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pathologic Complete Response
time frame: 26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens
description: Pathologic complete response is defined as the disappearance of all invasive cancer in the postsurgical breast and lymph node specimens after completion of neoadjuvant chemotherapy. Only residual intraductal carcinoma in the postsurgical breast specimen after neoadjuvant chemotherapy is also considered as the achievement of pathologic complete response.
arm group label: doxorubicin/cyclophosphamide
arm group type: Experimental
description: Neoadjuvant Chemotherapy with Docetaxel(Monotaxel®) after Doxorubicin plus Cyclophosphamide
intervention type: Drug
intervention name: Neoadjuvant Chemotherapy with Docetaxel
description: Doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (day 1), IV (in the vein), every 21 days, a total of 4 cycles -> Docetaxel 100 mg/m2 (day 1) IV, every 21 days, a total of 4 cycles
arm group label: doxorubicin/cyclophosphamide
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Docetaxel