<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/NCT03295552</url>
  </required_header>
  <id_info>
    <org_study_id>RJBC1701</org_study_id>
    <nct_id>NCT03295552</nct_id>
  </id_info>
  <brief_title>Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC</brief_title>
  <acronym>DETECT</acronym>
  <official_title>Decitabine Plus Carboplatin in the Treatment of Metastatic Triple Negative Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow enrollment.&#xD;
  </why_stopped>
  <start_date type="Actual">November 15, 2017</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</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>Overall response rate</measure>
    <time_frame>At the end of Cycle 6 (each cycle is 21 days)</time_frame>
    <description>Partial response (PR) + complete response (CR) rate</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Breast Neoplasm</condition>
  <arm_group>
    <arm_group_label>DC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DNA demethylating agent decitabine plus carboplatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>decitabine 7mg/m2, d1-d5, q3w</description>
    <arm_group_label>DC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>carboplatin AUC = 6, d6, q3w</description>
    <arm_group_label>DC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female aged between 18 years and 70 years old.&#xD;
&#xD;
          -  Pathologically confirmed metastatic triple negative breast cancer (TNBC).&#xD;
             Paraffin-embedded tissue were available from metastatic or primary sites to confirm&#xD;
             its TNBC status or for further translational research. TNBC was defined as ER-, PR-,&#xD;
             and HER2-.&#xD;
&#xD;
          -  Metastatic TNBC should not be treated with more than 1-line for metastatic disease.&#xD;
&#xD;
          -  Patients can not be treated with carboplatin in the metastatic setting.&#xD;
&#xD;
          -  For patients received carboplatin treatment in the adjuvant setting, they should have&#xD;
             at least one year disease interval between last dosage of carboplatin and trial&#xD;
             recruiting.&#xD;
&#xD;
          -  Patients had at least one measurable lesion according to RECIST criteria version 1.1.&#xD;
&#xD;
          -  ECOG Performance Status (PS) of 0-1.&#xD;
&#xD;
          -  Adequate liver and renal organ function.&#xD;
&#xD;
          -  Dated and signed IEC/IRB-approved informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than 1 one therapy for metastatic TNBC, Patients may receive bisphosphonates and&#xD;
             other therapies to treat bone metastases.&#xD;
&#xD;
          -  Less than four weeks since last radiotherapy.&#xD;
&#xD;
          -  Pregnancy or lactation or unwillingness to use adequate method of birth control.&#xD;
&#xD;
          -  Active or uncontrolled infection.&#xD;
&#xD;
          -  Hypersensitivity to carboplatin or decitabine&#xD;
&#xD;
          -  Male breast cancer.&#xD;
&#xD;
          -  Treated with any DNA demethylating agents&#xD;
&#xD;
          -  Young patients with pregnancy or lactation or unwillingness to use adequate method of&#xD;
             birth control.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kunwei Shen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Min Lu, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Kunwei Shen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>decitabine</keyword>
  <keyword>triple negative breast cancer</keyword>
  <keyword>carboplatin</keyword>
  <keyword>metastatic</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>Carboplatin</mesh_term>
    <mesh_term>Decitabine</mesh_term>
  </intervention_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/NCT03295552
org study id: RJBC1701
nct id: NCT03295552
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate
time frame: At the end of Cycle 6 (each cycle is 21 days)
description: Partial response (PR) + complete response (CR) rate
arm group label: DC
arm group type: Experimental
description: DNA demethylating agent decitabine plus carboplatin
intervention type: Drug
intervention name: Decitabine
description: decitabine 7mg/m2, d1-d5, q3w
arm group label: DC
intervention type: Drug
intervention name: Carboplatin
description: carboplatin AUC = 6, d6, q3w
arm group label: DC
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kunwei Shen, MD
role: Principal Investigator
affiliation: Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
last name: Min Lu, PHD
role: Principal Investigator
affiliation: Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Kunwei Shen
investigator title: Professor
mesh term: Breast Neoplasms
mesh term: Carboplatin
mesh term: Decitabine
sharing ipd: Undecided