<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/NCT02199418</url>
  </required_header>
  <id_info>
    <org_study_id>RenJiH-BC-001</org_study_id>
    <nct_id>NCT02199418</nct_id>
  </id_info>
  <brief_title>Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer</brief_title>
  <acronym>SHPD001</acronym>
  <official_title>Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based&#xD;
      regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant&#xD;
      chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the&#xD;
      trastuzumab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 2</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>Pathological complete response of breast and lymph nodes</measure>
    <time_frame>after 4 months preoperative treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerability and Safety</measure>
    <time_frame>4 months during neoadjuvant therapy</time_frame>
    <description>Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical and imaging response</measure>
    <time_frame>4 months during treatment</time_frame>
    <description>To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>regional recurrence free survival (RRFS)</measure>
    <time_frame>5 years</time_frame>
    <description>RRFS is defined as the time period between registration and first event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>local recurrence free survival (LRFS)</measure>
    <time_frame>5 years</time_frame>
    <description>LRFS is defined as the time period between registration and first event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>distant-disease- free survival (DDFS)</measure>
    <time_frame>5 years</time_frame>
    <description>DFS is defined as the time period between registration and first event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival (OS)</measure>
    <time_frame>5 years</time_frame>
    <description>OS is defined as the time period between registration and first event</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Tubular Breast Cancer</condition>
  <condition>Mucinous Breast Cancer</condition>
  <condition>Invasive Ductal Breast Cancer</condition>
  <condition>Inflammatory Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Paclitaxel and Cisplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.&#xD;
Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <arm_group_label>Paclitaxel and Cisplatin</arm_group_label>
    <other_name>Taxol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <arm_group_label>Paclitaxel and Cisplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women aged ≥18years and ≤70 years&#xD;
&#xD;
          2. At least on measurable disease according to the Response Evaluation Criteria in Solid&#xD;
             Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm,&#xD;
             T2-4 N0-2M0&#xD;
&#xD;
          3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER/PR positive is defined as &gt;1%&#xD;
             stained cells and HER2-positive is defined as immuno-histochemistry (IHC) 3+ or FISH&#xD;
             ratio ≥ 2.0&#xD;
&#xD;
          4. No prior systemic or loco-regional treatment of breast cancer&#xD;
&#xD;
          5. ECOG 0-2&#xD;
&#xD;
          6. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L,&#xD;
             Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine&#xD;
             aminotransferase (ALT)≤1.5 upper normal limit （UNL）, creatinine≤1.5 UNL,&#xD;
             bilirubin≤1.5UNL&#xD;
&#xD;
          7. No obvious main organs dysfunction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including&#xD;
             8 weeks) after final dose of test drug&#xD;
&#xD;
          2. Patient is pregnant or breast feeding&#xD;
&#xD;
          3. Inflammatory breast cancer and metastatic breast cancer&#xD;
&#xD;
          4. Any evidence of sense or motor nerve disorders&#xD;
&#xD;
          5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy,&#xD;
             including uncontrolled cardiovascular disease, severe infection&#xD;
&#xD;
          6. Any concurrent malignancy other than breast cancer&#xD;
&#xD;
          7. Know severe hypersensitivity to any drugs in 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>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Jiaotong University School of Medicine, Renji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RenJi Hospital</investigator_affiliation>
    <investigator_full_name>Jinsong Lu</investigator_full_name>
    <investigator_title>Director of Breast Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Inflammatory Breast Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ductal, Breast</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Cisplatin</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/NCT02199418
org study id: RenJiH-BC-001
nct id: NCT02199418
lead sponsor: 
has dmc: Yes
The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based
      regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast
      cancer.
In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant
      chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the
      trastuzumab.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pathological complete response of breast and lymph nodes
time frame: after 4 months preoperative treatment
measure: Tolerability and Safety
time frame: 4 months during neoadjuvant therapy
description: Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped
measure: Clinical and imaging response
time frame: 4 months during treatment
description: To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment
measure: regional recurrence free survival (RRFS)
time frame: 5 years
description: RRFS is defined as the time period between registration and first event
measure: local recurrence free survival (LRFS)
time frame: 5 years
description: LRFS is defined as the time period between registration and first event
measure: distant-disease- free survival (DDFS)
time frame: 5 years
description: DFS is defined as the time period between registration and first event
measure: overall survival (OS)
time frame: 5 years
description: OS is defined as the time period between registration and first event
arm group label: Paclitaxel and Cisplatin
arm group type: Experimental
description: Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.
Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year
intervention type: Drug
intervention name: Paclitaxel
arm group label: Paclitaxel and Cisplatin
other name: Taxol
intervention type: Drug
intervention name: Cisplatin
arm group label: Paclitaxel and Cisplatin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: RenJi Hospital
investigator full name: Jinsong Lu
investigator title: Director of Breast Surgery
mesh term: Breast Neoplasms
mesh term: Inflammatory Breast Neoplasms
mesh term: Carcinoma, Ductal, Breast
mesh term: Paclitaxel
mesh term: Cisplatin