<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/NCT02183805</url>
  </required_header>
  <id_info>
    <org_study_id>SYSUCC-004</org_study_id>
    <nct_id>NCT02183805</nct_id>
  </id_info>
  <brief_title>Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer</brief_title>
  <official_title>Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer</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>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop&#xD;
      growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow&#xD;
      the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To explore the progression-free survival of patients with metastatic triple-negative breast&#xD;
      cancer treated with peripheral blood stem cell transplant (PBSCT) followed by high dose&#xD;
      chemotherapy.&#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">June 17, 2014</start_date>
  <completion_date type="Actual">December 15, 2020</completion_date>
  <primary_completion_date type="Actual">December 15, 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</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Carcinoma Breast Stage IV</condition>
  <arm_group>
    <arm_group_label>Metastatic triple negative breast cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abraxane,Cyclophosphamide,Carboplatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abraxane,Cyclophosphamide,Carboplatin</intervention_name>
    <description>High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin</description>
    <arm_group_label>Metastatic triple negative breast cancer</arm_group_label>
    <other_name>Abraxane 800 mg/m2</other_name>
    <other_name>Cyclophosphamide 3g/m2</other_name>
    <other_name>Carboplatin 800 mg/m2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) 0 or 1.&#xD;
&#xD;
          -  Histologically or cytologically proven diagnosis of breast cancer with evidence of&#xD;
             locally recurrent or metastatic disease.&#xD;
&#xD;
          -  Documentation of estrogen and progestin receptor (ER/PR) negative status and HER2/neu&#xD;
             receptor negative status (ie, FISH negative or immunohistochemistry 0 or +1).&#xD;
&#xD;
          -  Obtained complete response or Good partial response after first line chemotherapy.&#xD;
&#xD;
          -  Normal organ function required prior to study entry.&#xD;
&#xD;
          -  Willingness to comply with treatment plans and other study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled central nervous system (CNS) involvement with disease&#xD;
&#xD;
          -  Fertile women unwilling to use contraceptive techniques during treatment&#xD;
&#xD;
          -  Females who are pregnant&#xD;
&#xD;
          -  Organ dysfunction.&#xD;
&#xD;
          -  Patients may not be receiving any other investigational agents.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhong-Yu 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>July 2021</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 18, 2021</last_update_submitted>
  <last_update_submitted_qc>July 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 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>Sun Yat-sen University Cancer Center</investigator_title>
  </responsible_party>
  <keyword>triple negative breast cancer</keyword>
  <keyword>autologous hematopoietic stem-cell transplantation</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>Cyclophosphamide</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Paclitaxel</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/NCT02183805
org study id: SYSUCC-004
nct id: NCT02183805
lead sponsor: 
has dmc: Yes
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop
      growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow
      the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
To explore the progression-free survival of patients with metastatic triple-negative breast
      cancer treated with peripheral blood stem cell transplant (PBSCT) followed by high dose
      chemotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free Survival
time frame: 24 months
measure: Overall Survival
time frame: 24 months
arm group label: Metastatic triple negative breast cancer
arm group type: Experimental
description: Abraxane,Cyclophosphamide,Carboplatin
intervention type: Drug
intervention name: Abraxane,Cyclophosphamide,Carboplatin
description: High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin
arm group label: Metastatic triple negative breast cancer
other name: Abraxane 800 mg/m2
other name: Cyclophosphamide 3g/m2
other name: Carboplatin 800 mg/m2
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zhong-Yu 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: Sun Yat-sen University Cancer Center
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Cyclophosphamide
mesh term: Carboplatin
mesh term: Albumin-Bound Paclitaxel
mesh term: Paclitaxel
sharing ipd: No