<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/NCT01732276</url>
  </required_header>
  <id_info>
    <org_study_id>20120314</org_study_id>
    <nct_id>NCT01732276</nct_id>
  </id_info>
  <brief_title>The Safety and Effects of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer</brief_title>
  <official_title>Phase Ⅱ Study of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangmen Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangmen Central Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast cancer is a heterogeneous disease and can be classified into several distinctive&#xD;
      subgroups. Triple-negative breast cancer(TNBC) is defined by lack of estrogen(ER),&#xD;
      progesterone(PR) immunoreactivity and lack of human epidermal receptor-2(HER2)&#xD;
      overexpression. TNBC comprises around 15% of all breast cancer and is characterized by its&#xD;
      aggressive clinical behavior and insensitivity toward available targeted treatment strategies&#xD;
      such as endocrine and anti-HER2 therapies.Although TNBC is sensitive to chemotherapy,early&#xD;
      relapse with metastatic disease is common and the prognosis is poor. Development Of novel&#xD;
      treatment strategies is,therefore,needed and the study of other potential targets in&#xD;
      TNBC,like tyrosine kinase receptors,is a topic of interest.&#xD;
&#xD;
      Epidermal Growth Factor Receptor(EGFR) is a transmembrane receptor tyrosine kinase that&#xD;
      encoded by cell erythroblastosis virus oncogene B1(C-erbB1) and belongs to the&#xD;
      HER/Erythroblastosis virus oncogene B(ErbB) family. By several signal pathways,EGFR regulates&#xD;
      cell proliferation, differentiation, apoptosis, invasion,and angiogenesis,and serves as a&#xD;
      poor prognostic factor.EGFR is overexpressed in a variety of malignancies including TNBC.Gene&#xD;
      expression profiling and immunohistochemical studies have indicated that 40 to 60% of TNBCs&#xD;
      exhibit EGFR expression and gene amplification was found in 18% of this subgroup,but EGFR&#xD;
      mutation was rare in TNBC.&#xD;
&#xD;
      By far,the role of gefitinib, an EGFR tyrosine kinase inhibitor(TKI),in the metastatic TNBC&#xD;
      has not been identified. Most clinical trials about EGFR TKIs in the breast cancer have one&#xD;
      or more limitations including:1) the study population had received heavily pretreatment;&#xD;
      2)the enrolled patients included several subgroups of breast cancer; 3)the expression of EGFR&#xD;
      was not clear in the enrolled patients.&#xD;
&#xD;
      Here, the investigators launch a prospective clinical trial, and about 50 patients with&#xD;
      triple-negative,EGFR positive metastatic breast cancer that have received at least second&#xD;
      line therapy will be enrolled. these patients will be treated with gefitinib, the toxicity&#xD;
      and effects of gefitinib will be recorded prospectively to evaluate the role of gefitinib in&#xD;
      the metastatic TNBC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">April 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>clinical benefit rate</measure>
    <time_frame>one month</time_frame>
    <description>The primary end point is objective clinical benefit rate defined as objective response or stable disease for≥24wk</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progress-free survival（PFS）</measure>
    <time_frame>every 4 weeks</time_frame>
    <description>Progress-free survival（PFS）is defined as the time from start of treatment to progression or death.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Toxicity</measure>
    <time_frame>twice weekly</time_frame>
    <description>Toxicity is assessed twice weekly and adverse effects(AEs) are classified according to the National Cancer Institute Common Toxicity Criteria(NCI-CTC).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>gefitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>gefitinib tablet 250mg/day by mouth until disease progression</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>gefitinib</intervention_name>
    <arm_group_label>gefitinib</arm_group_label>
    <other_name>IRRESA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  ≥1 measurable or assessable lesion&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group(ECOG)performance status of 0-2&#xD;
&#xD;
          -  adequate renal,hepatic and hematological function&#xD;
&#xD;
          -  a life expectancy of &gt;12 weeks&#xD;
&#xD;
          -  histologically proven EGFR positive metastatic TNBC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  brain metastasis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>gengsheng yu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of oncology, Jiangmen central hospital, Jiangmen, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>gengsheng yu</last_name>
    <phone>0086-0750-3165915</phone>
    <email>gengsheng_yu@hotmail.com</email>
  </overall_contact>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>November 30, 2012</last_update_submitted>
  <last_update_submitted_qc>November 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jiangmen Central Hospital</investigator_affiliation>
    <investigator_full_name>yu gengsheng</investigator_full_name>
    <investigator_title>vice director of oncology department, Jiangmen Central Hospital</investigator_title>
  </responsible_party>
  <keyword>Triple-negative breast cancer</keyword>
  <keyword>Epidermal growth factor receptor</keyword>
  <keyword>Gefitinib</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>Gefitinib</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/NCT01732276
org study id: 20120314
nct id: NCT01732276
lead sponsor: 
has dmc: Yes
Breast cancer is a heterogeneous disease and can be classified into several distinctive
      subgroups. Triple-negative breast cancer(TNBC) is defined by lack of estrogen(ER),
      progesterone(PR) immunoreactivity and lack of human epidermal receptor-2(HER2)
      overexpression. TNBC comprises around 15% of all breast cancer and is characterized by its
      aggressive clinical behavior and insensitivity toward available targeted treatment strategies
      such as endocrine and anti-HER2 therapies.Although TNBC is sensitive to chemotherapy,early
      relapse with metastatic disease is common and the prognosis is poor. Development Of novel
      treatment strategies is,therefore,needed and the study of other potential targets in
      TNBC,like tyrosine kinase receptors,is a topic of interest.

      Epidermal Growth Factor Receptor(EGFR) is a transmembrane receptor tyrosine kinase that
      encoded by cell erythroblastosis virus oncogene B1(C-erbB1) and belongs to the
      HER/Erythroblastosis virus oncogene B(ErbB) family. By several signal pathways,EGFR regulates
      cell proliferation, differentiation, apoptosis, invasion,and angiogenesis,and serves as a
      poor prognostic factor.EGFR is overexpressed in a variety of malignancies including TNBC.Gene
      expression profiling and immunohistochemical studies have indicated that 40 to 60% of TNBCs
      exhibit EGFR expression and gene amplification was found in 18% of this subgroup,but EGFR
      mutation was rare in TNBC.

      By far,the role of gefitinib, an EGFR tyrosine kinase inhibitor(TKI),in the metastatic TNBC
      has not been identified. Most clinical trials about EGFR TKIs in the breast cancer have one
      or more limitations including:1) the study population had received heavily pretreatment;
      2)the enrolled patients included several subgroups of breast cancer; 3)the expression of EGFR
      was not clear in the enrolled patients.

      Here, the investigators launch a prospective clinical trial, and about 50 patients with
      triple-negative,EGFR positive metastatic breast cancer that have received at least second
      line therapy will be enrolled. these patients will be treated with gefitinib, the toxicity
      and effects of gefitinib will be recorded prospectively to evaluate the role of gefitinib in
      the metastatic TNBC.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: clinical benefit rate
time frame: one month
description: The primary end point is objective clinical benefit rate defined as objective response or stable disease for≥24wk
measure: progress-free survival（PFS）
time frame: every 4 weeks
description: Progress-free survival（PFS）is defined as the time from start of treatment to progression or death.
measure: Toxicity
time frame: twice weekly
description: Toxicity is assessed twice weekly and adverse effects(AEs) are classified according to the National Cancer Institute Common Toxicity Criteria(NCI-CTC).
arm group label: gefitinib
arm group type: Experimental
description: gefitinib tablet 250mg/day by mouth until disease progression
intervention type: Drug
intervention name: gefitinib
arm group label: gefitinib
other name: IRRESA
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: gengsheng yu
role: Principal Investigator
affiliation: Department of oncology, Jiangmen central hospital, Jiangmen, China
last name: gengsheng yu
phone: 0086-0750-3165915
email: gengsheng_yu@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: Jiangmen Central Hospital
investigator full name: yu gengsheng
investigator title: vice director of oncology department, Jiangmen Central Hospital
mesh term: Breast Neoplasms
mesh term: Gefitinib