<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/NCT03792529</url>
  </required_header>
  <id_info>
    <org_study_id>2017KT40</org_study_id>
    <nct_id>NCT03792529</nct_id>
  </id_info>
  <brief_title>Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China</brief_title>
  <official_title>Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Predicine (Shanghai) Medical Technology Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University Cancer Hospital &amp; Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The anticipated objectives of this study are: 1) to understand the pathogenesis and molecular&#xD;
      typing of breast cancer patients in China (mainly HER2 overexpression, triple negative and&#xD;
      hormone receptor-positive patients) by detecting DNA and RNA in tumor tissue (fresh tissue or&#xD;
      paraffin section), and to compare the similarities and differences between the western&#xD;
      population and Chinese population; 2) plasma samples of patients with HER2 overexpression ,&#xD;
      hormone receptor-positive and triple negative (ER, PR, HER2 expression negative) were&#xD;
      sequenced for ctDNA and ctRNA, to find out whether there are genes or gene sets related to&#xD;
      therapeutic effect; 3) to study the specific changes of liquid molecular detection results&#xD;
      according to the previous research results, and establish mathematical models to predict and&#xD;
      monitor the effects of targeted therapy and endocrine therapy; 4) to compare liquid biopsy&#xD;
      and imaging and clinical features in monitoring clinical therapeutic effect, and to elaborate&#xD;
      the advantages and disadvantages of liquid biopsy and conventional imaging; 5) to provide&#xD;
      molecular detection basis for follow-up clinical research and screening for targets of new&#xD;
      drugs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</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>Change from baseline targeted mutation analysis of ctDNA</measure>
    <time_frame>From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months</time_frame>
    <description>ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ctDNA copy number loss related with progress free survival(PFS)</measure>
    <time_frame>From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months</time_frame>
    <description>ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ctDNA copy number loss related with Overall survival(OS)</measure>
    <time_frame>From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months</time_frame>
    <description>ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>breast cancer with HER2 overexpression</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>hormone receptor-positive breast cancer</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>triple negative breast cancer</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>detect gene mutations of ctDNA and ctRNA</intervention_name>
    <description>Samples were collected from patients at baseline, during therapy and after disease progression, and gene mutations of ctDNA and ctRNA were detected in the samples.</description>
    <arm_group_label>breast cancer with HER2 overexpression</arm_group_label>
    <arm_group_label>hormone receptor-positive breast cancer</arm_group_label>
    <arm_group_label>triple negative breast cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of breast cancer in China mainly with HER2 overexpression, triple negative and&#xD;
        hormone receptor-positive.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with first treated or recurrent metastatic breast cancer, according to RECIST&#xD;
             version 1.1 standard, confirmed by CT or MRI, have at least one measurable lesion.&#xD;
&#xD;
          -  HER2 positive or triple negative patients; (IHC++, fish amplification)&#xD;
&#xD;
          -  Patients with anti-HER2 treatment as first-line or not, and patients with HER2&#xD;
             positive can be treated with adjuvant therapy containing trastuzumab.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huiping Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Huiping Li, M.D.</last_name>
    <phone>(0086)13811012595</phone>
    <email>huipingli2012@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huiping LI, M.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 1, 2019</last_update_submitted>
  <last_update_submitted_qc>January 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Cancer Hospital &amp; Institute</investigator_affiliation>
    <investigator_full_name>Li Huiping</investigator_full_name>
    <investigator_title>Head of the department of breast oncology</investigator_title>
  </responsible_party>
  <keyword>Targeted Therapy</keyword>
  <keyword>Molecular Screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03792529
org study id: 2017KT40
nct id: NCT03792529
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The anticipated objectives of this study are: 1) to understand the pathogenesis and molecular
      typing of breast cancer patients in China (mainly HER2 overexpression, triple negative and
      hormone receptor-positive patients) by detecting DNA and RNA in tumor tissue (fresh tissue or
      paraffin section), and to compare the similarities and differences between the western
      population and Chinese population; 2) plasma samples of patients with HER2 overexpression ,
      hormone receptor-positive and triple negative (ER, PR, HER2 expression negative) were
      sequenced for ctDNA and ctRNA, to find out whether there are genes or gene sets related to
      therapeutic effect; 3) to study the specific changes of liquid molecular detection results
      according to the previous research results, and establish mathematical models to predict and
      monitor the effects of targeted therapy and endocrine therapy; 4) to compare liquid biopsy
      and imaging and clinical features in monitoring clinical therapeutic effect, and to elaborate
      the advantages and disadvantages of liquid biopsy and conventional imaging; 5) to provide
      molecular detection basis for follow-up clinical research and screening for targets of new
      drugs.
observational model: Cohort
time perspective: Prospective
measure: Change from baseline targeted mutation analysis of ctDNA
time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
description: ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.
measure: ctDNA copy number loss related with progress free survival(PFS)
time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
description: ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.
measure: ctDNA copy number loss related with Overall survival(OS)
time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
description: ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.
arm group label: breast cancer with HER2 overexpression
arm group label: hormone receptor-positive breast cancer
arm group label: triple negative breast cancer
intervention type: Other
intervention name: detect gene mutations of ctDNA and ctRNA
description: Samples were collected from patients at baseline, during therapy and after disease progression, and gene mutations of ctDNA and ctRNA were detected in the samples.
arm group label: breast cancer with HER2 overexpression
arm group label: hormone receptor-positive breast cancer
arm group label: triple negative breast cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Huiping Li
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Huiping Li, M.D.
phone: (0086)13811012595
email: huipingli2012@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University Cancer Hospital & Institute
investigator full name: Li Huiping
investigator title: Head of the department of breast oncology
mesh term: Breast Neoplasms
sharing ipd: Undecided