<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/NCT04456855</url>
  </required_header>
  <id_info>
    <org_study_id>SYSEC-KY-2018-018</org_study_id>
    <nct_id>NCT04456855</nct_id>
  </id_info>
  <brief_title>Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients</brief_title>
  <acronym>SYSBTC-001</acronym>
  <official_title>Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First People's Hospital of Foshan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</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>
      Current guidelines lack definitive evidences about the relative benefits of locoregional&#xD;
      surgery for the primary tumor in de novo stage IV breast cancer. The aim of this study&#xD;
      (SYSBTC-001) was to investigate the role of locoregional surgery for primary tumor in de novo&#xD;
      stage IV breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Anticipated">July 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>The association between locoregional surgery and overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Locoregional progression free survival</measure>
    <time_frame>5 years</time_frame>
    <description>Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant progression free survival</measure>
    <time_frame>5 years</time_frame>
    <description>Distant disease free survival (D-DFS), which defined as the time from the diagnosis of de novo stage IV breast cancer to the confirmed time of distant progression, or death due to any other cause.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">358</enrollment>
  <condition>Breast Neoplasm Female</condition>
  <condition>Surgery</condition>
  <condition>Advanced Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Locoregional surgery</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>No surgery</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Locoregional surgery</intervention_name>
    <description>Patients had pathologically confirmed operable stage IV breast infiltrating carcinoma at initial presentation, and had locoregional surgery for the breast cancer.</description>
    <arm_group_label>Locoregional surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Operable stage IV breast cancer patients, whose primary lesion is invasive breast cancer&#xD;
        confirmed by pathology, and metastases can be confirmed by pathology or imaginology&#xD;
        examination&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Operable stage IV breast cancer patients,whose primary lesion is invasive breast&#xD;
             cancer confirmed by pathology, and metastases can be confirmed by pathology or&#xD;
             imageology examination.&#xD;
&#xD;
          -  ECOG-PS 0-2.&#xD;
&#xD;
          -  Bone marrow, liver and kidney should be fully functional.&#xD;
&#xD;
          -  Patients received the locoregional surgery of the primary tumor in de novo in our&#xD;
             center, or didn't received the locoregional surgery of the primary tumor in de novo.&#xD;
&#xD;
          -  For the patient who accepted systematic treatment before operation, the systematic&#xD;
             treatment must be administered within a year since diagnosed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Accompanied with other primary malignant tumors.&#xD;
&#xD;
          -  Patients who can't plan for follow-up effectively and regularly.&#xD;
&#xD;
          -  Multiple liver metastasis and ALT/AST four times higher than normal at patients' first&#xD;
             diagnosis.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Herui Yao, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jun Tang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guolin Ye, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First People's Hospital of Foshan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Herui Yao, PhD</last_name>
    <phone>+8613500018020</phone>
    <email>yaoherui@mail.sysu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yunfang Yu, MD</last_name>
    <phone>+8613660238987</phone>
    <email>yuyf9@mail.sysu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>First People's Hospital of Foshan</name>
      <address>
        <city>Foshan</city>
        <state>Guangdong</state>
        <zip>528000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guolin Ye, PhD</last_name>
      <email>13902816950@139.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sun Yat-Sen Memorial Hospital of Sun Yat-sen</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Herui Yao, PhD</last_name>
      <phone>+8613500018020</phone>
      <email>yaoherui@mail.sysu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Tang, PhD</last_name>
      <email>tangjun@sysucc.org.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Herui Yao</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast Neoplasm Female</keyword>
  <keyword>Locoregional surgery</keyword>
  <keyword>In de novo stage IV brest cancer</keyword>
  <keyword>Overall survival</keyword>
  <keyword>Locoregional progression free survival</keyword>
  <keyword>Distant progression free survival</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>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/NCT04456855
org study id: SYSEC-KY-2018-018
nct id: NCT04456855
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Current guidelines lack definitive evidences about the relative benefits of locoregional
      surgery for the primary tumor in de novo stage IV breast cancer. The aim of this study
      (SYSBTC-001) was to investigate the role of locoregional surgery for primary tumor in de novo
      stage IV breast cancer.
observational model: Cohort
time perspective: Retrospective
measure: Overall survival
time frame: 5 years
description: The association between locoregional surgery and overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.
measure: Locoregional progression free survival
time frame: 5 years
description: Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.
measure: Distant progression free survival
time frame: 5 years
description: Distant disease free survival (D-DFS), which defined as the time from the diagnosis of de novo stage IV breast cancer to the confirmed time of distant progression, or death due to any other cause.
arm group label: Locoregional surgery
arm group label: No surgery
intervention type: Procedure
intervention name: Locoregional surgery
description: Patients had pathologically confirmed operable stage IV breast infiltrating carcinoma at initial presentation, and had locoregional surgery for the breast cancer.
arm group label: Locoregional surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Herui Yao, PhD
role: Study Chair
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
last name: Jun Tang, PhD
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Guolin Ye, PhD
role: Principal Investigator
affiliation: First People's Hospital of Foshan
last name: Herui Yao, PhD
phone: +8613500018020
email: yaoherui@mail.sysu.edu.cn
last name: Yunfang Yu, MD
phone: +8613660238987
email: yuyf9@mail.sysu.edu.cn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
investigator full name: Herui Yao
investigator title: Principal Investigator
mesh term: Breast Neoplasms
sharing ipd: No