<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/NCT03006614</url>
  </required_header>
  <id_info>
    <org_study_id>2014-FXY-077-内科</org_study_id>
    <nct_id>NCT03006614</nct_id>
  </id_info>
  <brief_title>PERS Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer</brief_title>
  <acronym>PERS</acronym>
  <official_title>Using PERS(PErsonalized Regimen Selection) Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer Multicentric, Prospective, Randomized Controlled Phase III Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shi Yanxia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to explore new PERS prediction model can improve the pathological complete&#xD;
      response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, prospective, randomized phase III clinical trial. Planning 320 cases.&#xD;
&#xD;
      This study will be divided into two stages. Phase one, 120 cases of local advanced breast&#xD;
      cancer (LABC)who need neoadjuvant chemotherapy. Gene prediction model test(PERS) is performed&#xD;
      before treatment(ddEC-T+/-H), verify the prediction efficacy of PERS.&#xD;
&#xD;
      Phase two, 200 cases of LABC primary resistant of antharcycline and taxans. Patients were&#xD;
      randomized to Arm ddEC-T+/-H and Arm PERS (regimens according to PERS,eg&#xD;
      NVB+DDP,capacitabine,gemcitabine and so on) pCR rate and DFS is observed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>Phase 3</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>Surgical specimens of breast primary tumors and axillary lymph nodes as measured by Pathological examination.</measure>
    <time_frame>up to 96 months</time_frame>
    <description>pCR(pathologic complete response)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time as a measure from randomization to disease recurrence or patients died due to disease progression.</measure>
    <time_frame>up to 96 months</time_frame>
    <description>DFS(Disease-free survival)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by NCI(National Cancer Institude) CTC (Clinical Trials Center)v3.0</measure>
    <time_frame>up to 96 months</time_frame>
    <description>Safety evaluation</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Breast Cancer Model</condition>
  <condition>Effects of Chemotherapy</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>PERS:NVB,DDP,GEM,CAP,H etc.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vinorelbine 25mg/m2 d1,d8 iv,q3w cisplatin 70mg/m2 d1，q3w gemcitabine 1000mg/m2 d1,d8,q3w capecitabine 1000mg/m2,bid,d1-14,q3w Trastuzumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EPI+CTX-T+/-H</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epirubicin 90mg/m2 d1+ CTX 600mg/m2 d1 q2w, Docetaxel 75mg/m2 +/-herceptin d1,q3w</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVB</intervention_name>
    <arm_group_label>PERS:NVB,DDP,GEM,CAP,H etc.</arm_group_label>
    <other_name>vinorelbine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EPI</intervention_name>
    <arm_group_label>EPI+CTX-T+/-H</arm_group_label>
    <other_name>epirubicin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DDP</intervention_name>
    <arm_group_label>PERS:NVB,DDP,GEM,CAP,H etc.</arm_group_label>
    <other_name>cisplatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CAP</intervention_name>
    <arm_group_label>PERS:NVB,DDP,GEM,CAP,H etc.</arm_group_label>
    <other_name>capecitabine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GEM</intervention_name>
    <arm_group_label>PERS:NVB,DDP,GEM,CAP,H etc.</arm_group_label>
    <other_name>gemcitabine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>H</intervention_name>
    <arm_group_label>EPI+CTX-T+/-H</arm_group_label>
    <arm_group_label>PERS:NVB,DDP,GEM,CAP,H etc.</arm_group_label>
    <other_name>Trastuzumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CTX</intervention_name>
    <arm_group_label>EPI+CTX-T+/-H</arm_group_label>
    <other_name>cyclophosphamidem</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>T</intervention_name>
    <arm_group_label>EPI+CTX-T+/-H</arm_group_label>
    <other_name>docetaxel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria: all of the patients in the trial need to meet&#xD;
&#xD;
          -  age: at least 18 years old;&#xD;
&#xD;
          -  ECOG(Eastern Cooperative Oncology Group) scoring ≤1;&#xD;
&#xD;
          -  confirmed by histology or cytology breast infiltrating ductal carcinoma&#xD;
&#xD;
          -  agreed to breast cancer tissue biopsy&#xD;
&#xD;
          -  here is a new adjuvant chemotherapy against patients with stage II/III&#xD;
&#xD;
          -  According to RECIST criteria, target lesion in patients with at least one, at least&#xD;
             one single diameter measurable lesions .Is defined as a measurable lesions with the&#xD;
             following method can accurately measure at least one of the diameter of the lesion:&#xD;
             lesions or greater diameter 20 mm or measured in conventional methods spiral CT&#xD;
             measurement lesions 10 mm diameter or greater. Positron emission tomography (CT) and&#xD;
             ultrasound can not be used as measurement method lesions.&#xD;
&#xD;
          -  The normal numerical laboratory： The patient's level of organ function must meet the&#xD;
             following requirements: enough reserves: bone marrow neutrophils (cent leaves and&#xD;
             ribbon neutrophils) absolute count (ANC) ≥1.5*109 / L, or platelets≥ 100*109 / L, or&#xD;
             acuity ≥ 9 g/dL and hemoglobin.Liver: bilirubin &lt; 1.5 times the upper limit of normal,&#xD;
             alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine&#xD;
             aminotransferase (ALT) &lt; 3.0 times the upper limit of normal (If allowed to AP with&#xD;
             liver metastasis, AST, ALT &lt; 5 times the upper limit of normal).Kidney： creatinine&#xD;
             clearance or 45 mL/min.&#xD;
&#xD;
          -  Signed informed consent;&#xD;
&#xD;
          -  is expected to survival in patients with 3 or more months.&#xD;
&#xD;
          -  patient adherence and geographic location of residence meet the needs of the&#xD;
             follow-up.&#xD;
&#xD;
          -  in the research into the group of 7 days before the serum or urine pregnancy test must&#xD;
             be negative, and must be for the nursing of patients.Or sterilization surgery,&#xD;
             patients after menopause, or agreed to in the research during the treatment and&#xD;
             research within 6 months after the end of the treatment period using an approved by&#xD;
             the medical contraception (such as intrauterine device (IUD), pill or condoms)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ECOG(Eastern Cooperative Oncology Group) scoring ≥2 ;&#xD;
&#xD;
          -  At the same time to accept any other anti-tumor treatment.&#xD;
&#xD;
          -  In the past 12 months have congestive heart failure, drug treatment can't control&#xD;
             history of arrhythmia, myocardial infarction, etc;&#xD;
&#xD;
          -  The serious, which has not been controlled intercurrent infection, organ dysfunction,&#xD;
             or serious metabolic disorder of patients;&#xD;
&#xD;
          -  Active infection (decided by the researchers.&#xD;
&#xD;
          -  According to the researcher's judgment, there is serious to endanger the safety of&#xD;
             patients, or patients completed the research associated with disease.&#xD;
&#xD;
          -  Pregnancy or breast-feeding women.&#xD;
&#xD;
          -  Always have a clear history of neurological or psychiatric disorders, including&#xD;
             epilepsy, or dementia.&#xD;
&#xD;
          -  A history of other tumors or combined with other tumor patients.&#xD;
&#xD;
          -  Before study enrollment for any reason within 30 days of use had not been approved by&#xD;
             the local drug ；&#xD;
&#xD;
          -  Unwilling or unable to continue to comply with the experimental program, or can not&#xD;
             cope with patients follow-up;&#xD;
&#xD;
          -  Researchers think that is unfavorable to the participants.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>YanXia Shi, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen university of cancer center Recruiting</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>YanXia Shi, doctor</last_name>
    <phone>02087343488</phone>
    <email>shiyanxia@sysucc.org.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cong Xue, doctor</last_name>
    <phone>02087343488</phone>
    <email>xuecong@sysucc.org.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanxia Shi, doctor</last_name>
      <phone>13609058827</phone>
      <email>shiyx@sysucc.org.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>April 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Shi Yanxia</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer Model</keyword>
  <keyword>Effects of Chemotherapy</keyword>
  <keyword>breast cancer</keyword>
  <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>Cisplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>Vinorelbine</mesh_term>
    <mesh_term>Epirubicin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03006614
org study id: 2014-FXY-077-内科
nct id: NCT03006614
lead sponsor: 
has dmc: No
This study aims to explore new PERS prediction model can improve the pathological complete
      response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival.
This is a multi-center, prospective, randomized phase III clinical trial. Planning 320 cases.

      This study will be divided into two stages. Phase one, 120 cases of local advanced breast
      cancer (LABC)who need neoadjuvant chemotherapy. Gene prediction model test(PERS) is performed
      before treatment(ddEC-T+/-H), verify the prediction efficacy of PERS.

      Phase two, 200 cases of LABC primary resistant of antharcycline and taxans. Patients were
      randomized to Arm ddEC-T+/-H and Arm PERS (regimens according to PERS,eg
      NVB+DDP,capacitabine,gemcitabine and so on) pCR rate and DFS is observed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Surgical specimens of breast primary tumors and axillary lymph nodes as measured by Pathological examination.
time frame: up to 96 months
description: pCR(pathologic complete response)
measure: Time as a measure from randomization to disease recurrence or patients died due to disease progression.
time frame: up to 96 months
description: DFS(Disease-free survival)
measure: Number of participants with treatment-related adverse events as assessed by NCI(National Cancer Institude) CTC (Clinical Trials Center)v3.0
time frame: up to 96 months
description: Safety evaluation
arm group label: PERS:NVB,DDP,GEM,CAP,H etc.
arm group type: Experimental
description: vinorelbine 25mg/m2 d1,d8 iv,q3w cisplatin 70mg/m2 d1，q3w gemcitabine 1000mg/m2 d1,d8,q3w capecitabine 1000mg/m2,bid,d1-14,q3w Trastuzumab
arm group label: EPI+CTX-T+/-H
arm group type: Active Comparator
description: Epirubicin 90mg/m2 d1+ CTX 600mg/m2 d1 q2w, Docetaxel 75mg/m2 +/-herceptin d1,q3w
intervention type: Drug
intervention name: NVB
arm group label: PERS:NVB,DDP,GEM,CAP,H etc.
other name: vinorelbine
intervention type: Drug
intervention name: EPI
arm group label: EPI+CTX-T+/-H
other name: epirubicin
intervention type: Drug
intervention name: DDP
arm group label: PERS:NVB,DDP,GEM,CAP,H etc.
other name: cisplatin
intervention type: Drug
intervention name: CAP
arm group label: PERS:NVB,DDP,GEM,CAP,H etc.
other name: capecitabine
intervention type: Drug
intervention name: GEM
arm group label: PERS:NVB,DDP,GEM,CAP,H etc.
other name: gemcitabine
intervention type: Drug
intervention name: H
arm group label: EPI+CTX-T+/-H
arm group label: PERS:NVB,DDP,GEM,CAP,H etc.
other name: Trastuzumab
intervention type: Drug
intervention name: CTX
arm group label: EPI+CTX-T+/-H
other name: cyclophosphamidem
intervention type: Drug
intervention name: T
arm group label: EPI+CTX-T+/-H
other name: docetaxel
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: YanXia Shi, doctor
role: Principal Investigator
affiliation: Sun Yat-sen university of cancer center Recruiting
last name: YanXia Shi, doctor
phone: 02087343488
email: shiyanxia@sysucc.org.cn
last name: Cong Xue, doctor
phone: 02087343488
email: xuecong@sysucc.org.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Shi Yanxia
investigator title: Principal Investigator, Clinical Professor
mesh term: Breast Neoplasms
mesh term: Cisplatin
mesh term: Gemcitabine
mesh term: Docetaxel
mesh term: Capecitabine
mesh term: Trastuzumab
mesh term: Vinorelbine
mesh term: Epirubicin
sharing ipd: No