<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/NCT01732939</url>
  </required_header>
  <id_info>
    <org_study_id>307BCNeo-01</org_study_id>
    <nct_id>NCT01732939</nct_id>
  </id_info>
  <brief_title>Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Affiliated to Military Medical Science, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Affiliated to Military Medical Science, Beijing</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for&#xD;
      invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus&#xD;
      taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hope to get preliminary results for the breast cancer patients who are&#xD;
      given different neoadjuvant chemothetapy regimens. The patients are randomized two&#xD;
      chemotherapy regimens. One is anthracyclines plus taxanes for 6-8 cycles,the other is&#xD;
      anthracyclines plus taxanes for 3-4 cycles ,then switch tovinorelbine plus cisplatinum for&#xD;
      3-4 cycles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">May 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pathological complete response rate</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical response rate, safety</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>AT</arm_group_label>
    <description>Docetaxel 75 mg/m2, day 1 or paclitaxel 175mg/m2 day 1 plus Epirubicin 75 mg/m2, day 1 or doxorubicine 50mg/m2 day 1 for 6-8 cycles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AT-NP</arm_group_label>
    <description>docetaxel 75mg/m2,day 1 or paclitaxel 175mg/m2,day 1 plus doxorubicine 50mg/m2,day 1 or epirubicin 75mg/m2, day 1,for3-4 cycles then switch to vinorelbine 25mg/m2, day 1 and day 8 plus cisplatinum 75mg/m2, day 1 for 3-4 cycles</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        diaganosis of invasive breast cancer, tumor size &gt; 2.0cm by MRI or ultrasound or clinical&#xD;
        examination.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of invasive ductal or lobular breast cancer.&#xD;
&#xD;
          -  Previously untreated (no chemotherapy or hormonal therapy or radiation therapy)&#xD;
             invasive breast cancer.&#xD;
&#xD;
          -  no anti-Her2 therapy if HER2 positive ( defined as 3+ IHC or FISH positive)&#xD;
&#xD;
          -  Performance Status ECOG &lt;2&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Tumor &gt; 2.0 cm by MRI and/or sonographic or clinical exam measurements.or Karnofsky&#xD;
             &gt;50%&#xD;
&#xD;
          -  Lab test :&#xD;
&#xD;
               -  Absolute neutrophil count &gt; 1,500/mm3&#xD;
&#xD;
                    -  Total Bilirubin ≤ 2×ULN&#xD;
&#xD;
                    -  AST and ALT ≤ 2.5×ULN&#xD;
&#xD;
               -  serum creatinine ≤ 1.5×ULN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast feeding patients are excluded&#xD;
&#xD;
          -  stage Ⅳ breast cancer&#xD;
&#xD;
          -  History of non-breast malignancies within the 5 years prior to study entry, except for&#xD;
             the following: carcinoma in situ of the cervix, carcinoma in situ of the&#xD;
             colon,melanoma in situ, and basal cell and squamous cell carcinomas of the skin&#xD;
&#xD;
          -  uncontrolled cardiac disease&#xD;
&#xD;
          -  Active infection or chronic infection requiring chronic suppressive antibiotics&#xD;
&#xD;
          -  History of hypersensitivity reaction to investigating drugs&#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>Zefei Jiang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Affiliated Military Medical Science</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital affiliated academy military medical science</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tao Wang, MD</last_name>
      <phone>8610-66947430</phone>
    </contact>
    <contact_backup>
      <last_name>Shaohua ZHANG, MD</last_name>
      <phone>8610-66947173</phone>
    </contact_backup>
    <investigator>
      <last_name>Zefei Jiang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>February 17, 2014</last_update_submitted>
  <last_update_submitted_qc>February 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 19, 2014</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>
  <!-- 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/NCT01732939
org study id: 307BCNeo-01
nct id: NCT01732939
lead sponsor: 
has dmc: No
The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for
      invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus
      taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.
The investigators hope to get preliminary results for the breast cancer patients who are
      given different neoadjuvant chemothetapy regimens. The patients are randomized two
      chemotherapy regimens. One is anthracyclines plus taxanes for 6-8 cycles,the other is
      anthracyclines plus taxanes for 3-4 cycles ,then switch tovinorelbine plus cisplatinum for
      3-4 cycles.
observational model: Cohort
time perspective: Prospective
measure: pathological complete response rate
time frame: one year
measure: clinical response rate, safety
time frame: one year
arm group label: AT
description: Docetaxel 75 mg/m2, day 1 or paclitaxel 175mg/m2 day 1 plus Epirubicin 75 mg/m2, day 1 or doxorubicine 50mg/m2 day 1 for 6-8 cycles
arm group label: AT-NP
description: docetaxel 75mg/m2,day 1 or paclitaxel 175mg/m2,day 1 plus doxorubicine 50mg/m2,day 1 or epirubicin 75mg/m2, day 1,for3-4 cycles then switch to vinorelbine 25mg/m2, day 1 and day 8 plus cisplatinum 75mg/m2, day 1 for 3-4 cycles
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zefei Jiang, MD
role: Principal Investigator
affiliation: Hospital Affiliated Military Medical Science
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms