<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/NCT03244358</url>
  </required_header>
  <id_info>
    <org_study_id>SYSUCC-010</org_study_id>
    <nct_id>NCT03244358</nct_id>
  </id_info>
  <brief_title>Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer</brief_title>
  <official_title>Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer:A Single Arm,Single Center,Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple&#xD;
      negative breast&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase II,single center,prospective, single arm clinical trials. The objective is to&#xD;
      evaluate the efficacy and safetyof Epalrestat in the treatment of metastatic triple negative&#xD;
      breast.Primary endpoint is 16-week clinical benefit rate (CBR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty accruing subjects the study accrual was closed&#xD;
  </why_stopped>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>Progression-free survival (PFS)</measure>
    <time_frame>30 months</time_frame>
    <description>the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>30 months</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>3 years</time_frame>
    <description>OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Triple Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Epalrestat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Epalrestat added to standard treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epalrestat</intervention_name>
    <description>Epalrestat 50mg tid added to standard chemotherapy treatment</description>
    <arm_group_label>Epalrestat</arm_group_label>
    <other_name>Tanglin (Yangtze River Pharmaceutical Group), China</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female ≥ 18 years, ≤70 years.&#xD;
&#xD;
          -  Minimum life expectancy 16 weeks&#xD;
&#xD;
          -  Histologicalconfirmation of hormone receptor negative and HER2 negative breast&#xD;
             cancer(IHC:ER -, PR-) on primary tumour at diagnosis/on biopsy of metastasis&#xD;
&#xD;
          -  Clinical or histological confirmation of metastatic or locally advanced disease not&#xD;
             amenable to curative surgical resection&#xD;
&#xD;
          -  ECOG 0-2 with no deterioration over previous 2 weeks Measurable disease&#xD;
&#xD;
          -  Adequate bone marrow and organ function&#xD;
&#xD;
          -  Availability of archival tumour sample or fresh biopsy Informed consent&#xD;
&#xD;
          -  Normal organ function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour&#xD;
             embolisation &lt;21 days prior to study treatment&#xD;
&#xD;
          -  Last dose of palliative radiotherapy &lt;7 days prior to study treatment&#xD;
&#xD;
          -  Rapidly progressive visceral disease not suitable for further therapy&#xD;
&#xD;
          -  Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and&#xD;
             stable and not requiring steroids for ≥ 4 weeks study treatment&#xD;
&#xD;
          -  Major surgery (excluding placement of vascular access) within 4 weeks before study&#xD;
             treatment&#xD;
&#xD;
          -  Evidence of severe or uncontrolled systemic diseases, including uncontrolled&#xD;
             hypertension, active bleeding diatheses, or active infection including hepatitis B,&#xD;
             hepatitis C and HIV&#xD;
&#xD;
          -  With the exception of alopecia, any unresolved toxicities from previous therapy&#xD;
             greater than CTCAE grade 1 before study treatment&#xD;
&#xD;
          -  Elevated ALP in absence of bone metastasis&#xD;
&#xD;
          -  Evidence of dementia, altered mental status or any psychiatric condition that would&#xD;
             prohibit understanding or rendering of informed consent&#xD;
&#xD;
          -  Participation in another study with investigational product during last 30 days&#xD;
&#xD;
          -  Inability or unwillingness to comply with study procedures, including inability to&#xD;
             take regular oral medication&#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>zhongyu yuan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sun Yat-sen University, Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Zhong-yu Yuan</investigator_full_name>
    <investigator_title>professer</investigator_title>
  </responsible_party>
  <keyword>Triple Negative Breast Cancer</keyword>
  <keyword>Epalrestat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epalrestat</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/NCT03244358
org study id: SYSUCC-010
nct id: NCT03244358
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple
      negative breast
This is a phase II,single center,prospective, single arm clinical trials. The objective is to
      evaluate the efficacy and safetyof Epalrestat in the treatment of metastatic triple negative
      breast.Primary endpoint is 16-week clinical benefit rate (CBR).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival (PFS)
time frame: 30 months
description: the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: 30 months
description: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
measure: Overall Survival
time frame: 3 years
description: OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
arm group label: Epalrestat
arm group type: Experimental
description: Epalrestat added to standard treatment
intervention type: Drug
intervention name: Epalrestat
description: Epalrestat 50mg tid added to standard chemotherapy treatment
arm group label: Epalrestat
other name: Tanglin (Yangtze River Pharmaceutical Group), China
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: zhongyu yuan, M.D.
role: Principal Investigator
affiliation: Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Zhong-yu Yuan
investigator title: professer
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Epalrestat
sharing ipd: No