<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/NCT04426136</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-2020-EBC</org_study_id>
    <nct_id>NCT04426136</nct_id>
  </id_info>
  <brief_title>A Prospective Cohort Study Comparing Disparity in Surgical Procedure (Wide Local Excision Only vs Any Other Surgery Procedures) Among the Elderly Breast Cancer Patients</brief_title>
  <official_title>Qiang Sun，Department of Breast Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The incidence and mortality rates of breast cancer are still increasing in both developing&#xD;
      and developed countries. The number of women ≥70 years who are affected by breast cancer (BC)&#xD;
      worldwide is also on the increase. Based on the largest population and increasing aging, BC&#xD;
      is also rapidly increasing among the elderly in China. According to the epidemiological&#xD;
      profile data regarding BC in China, the second onset age peak of BC morbidity occurred after&#xD;
      70 years old and in 2020, the proportion of patients older than 65 is expected to exceed&#xD;
      one-fifth and reach 27.0% by 2030. However, some controversies remain to be resolved due to&#xD;
      the lack of high quality evidence. The tumor biological behavior, treatment choice and&#xD;
      treatment tolerance among the elderly prominently differ from their young counterparts.&#xD;
      Besides, they are rarely enrolled in large-scale randomized clinical trials or prospective&#xD;
      cohort studies and the results are obtained mainly from retrospective studies. Also, frequent&#xD;
      deviations from the standard guidelines lead to insufficient or excessive treatments, though&#xD;
      the so-called standard guidelines are based on the clinicopathological characteristics and&#xD;
      research findings among the younger BC patients. Studies focusing on the global population&#xD;
      confirmed that the biological behavior of tumors among elderly patients was more favorable&#xD;
      compared with younger patients but did not transform into survival benefits eventually.&#xD;
      Numerous prospective, randomized trials have demonstrated that breast conserving surgery&#xD;
      (BCS), consisting of segmental mastectomy and radiation treatment with or without axillary&#xD;
      lymph node dissection (ALND), is equivalent to mastectomy in terms of overall survival (OS)&#xD;
      and disease free survival (DFS) for patients with early stage breast carcinoma. Presentation&#xD;
      of the ACOZOG-Z011 study results in 2011 resulted in a downward trend in the use of a&#xD;
      completion axillary lymph node dissection in early breast cancer patients with 1-2 positive&#xD;
      sentinel lymph nodes (SLN), treated with wide local excision (WLE) and whole breast&#xD;
      irradiation. However, there is little evidence regarding the optimal axillary treatment in&#xD;
      elderly breast cancer patients, since these patients are often excluded from clinical trials.&#xD;
      We had done a retrospective study of breast cancer in the elderly, which demonstrated that&#xD;
      those who with complex comorbidities receiving wide local excision merely were about 1.5&#xD;
      times more than those who without (71.2% vs 46.0%, p&lt;0.001). However, it is paradoxical that,&#xD;
      on the one hand, the risk of dying from breast cancer may increase if patients do not receive&#xD;
      the standard treatment; on the other hand, they could not live long enough to benefit or even&#xD;
      suffer more from the standard treatment. The key is to figure out who they are. Given the&#xD;
      high proportion of patients treated only with WLE, we believe that it is important to compare&#xD;
      the effects of different surgical procedures on prognosis among the elderly BC patient in a&#xD;
      prospective cohort study, to be more specific, comparing the WLE versus any other surgical&#xD;
      procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">June 2027</completion_date>
  <primary_completion_date type="Anticipated">June 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>disease free survival</measure>
    <time_frame>From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 72 months</time_frame>
    <description>the time interval from surgery to disease recurrence or metastasis or considered as still alive at the observation deadline or missed during follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>From date of surgery until the date of death from any cause, assessed up to 72 months</time_frame>
    <description>the time interval from surgery to all cause death or considered as still alive at the observation deadline or missed during follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>breast cancer-specific survival</measure>
    <time_frame>From date of surgery until the date of death from breast cancer related cause, assessed up to 72 months</time_frame>
    <description>the time interval from surgery to breast cancer related death or considered as still alive at the observation deadline or missed during follow-up</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Elderly Patient</condition>
  <condition>Wide Local Excision</condition>
  <condition>Surgery</condition>
  <condition>Survival Outcomes</condition>
  <arm_group>
    <arm_group_label>1. WLE group</arm_group_label>
    <description>patients in this group receiving WLE merely</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2. other method group</arm_group_label>
    <description>patients in this group receiving any other surgical procedures except WLE</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        We intend to enroll all patients who have been treated in the breast surgery department of&#xD;
        our hospital and meet the inclusion criteria from the date of enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of breast cancer&#xD;
&#xD;
          -  Received surgical treatment in this institution&#xD;
&#xD;
          -  Specific surgical method data available&#xD;
&#xD;
          -  Demographic and pathological data available&#xD;
&#xD;
          -  No clear evidence of distant metastasis&#xD;
&#xD;
          -  Agree to participate in the trial and receive long-term follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being intolerant of surgical treatment&#xD;
&#xD;
          -  Distant metastases have been merged&#xD;
&#xD;
          -  Patients who had simultaneous bilateral breast cancer&#xD;
&#xD;
          -  Follow-up interval being less than 12 months except reaching endpoints of observation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Qiang Sun, Professor</last_name>
    <phone>008613811669255</phone>
    <email>sunqiangpumc@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ying Zhong, Doctor</last_name>
    <email>zhongying_pumc@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Breast Surgery,Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Qiang Sun, Professor</last_name>
      <phone>008613811669255</phone>
      <email>sunqiangpumc@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Ying Zhong, Doctor</last_name>
      <email>zhongying_pumc@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ying Zhong, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>elderly</keyword>
  <keyword>breast cancer</keyword>
  <keyword>wide local excision</keyword>
  <keyword>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>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/NCT04426136
org study id: PUMCH-2020-EBC
nct id: NCT04426136
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The incidence and mortality rates of breast cancer are still increasing in both developing
      and developed countries. The number of women ≥70 years who are affected by breast cancer (BC)
      worldwide is also on the increase. Based on the largest population and increasing aging, BC
      is also rapidly increasing among the elderly in China. According to the epidemiological
      profile data regarding BC in China, the second onset age peak of BC morbidity occurred after
      70 years old and in 2020, the proportion of patients older than 65 is expected to exceed
      one-fifth and reach 27.0% by 2030. However, some controversies remain to be resolved due to
      the lack of high quality evidence. The tumor biological behavior, treatment choice and
      treatment tolerance among the elderly prominently differ from their young counterparts.
      Besides, they are rarely enrolled in large-scale randomized clinical trials or prospective
      cohort studies and the results are obtained mainly from retrospective studies. Also, frequent
      deviations from the standard guidelines lead to insufficient or excessive treatments, though
      the so-called standard guidelines are based on the clinicopathological characteristics and
      research findings among the younger BC patients. Studies focusing on the global population
      confirmed that the biological behavior of tumors among elderly patients was more favorable
      compared with younger patients but did not transform into survival benefits eventually.
      Numerous prospective, randomized trials have demonstrated that breast conserving surgery
      (BCS), consisting of segmental mastectomy and radiation treatment with or without axillary
      lymph node dissection (ALND), is equivalent to mastectomy in terms of overall survival (OS)
      and disease free survival (DFS) for patients with early stage breast carcinoma. Presentation
      of the ACOZOG-Z011 study results in 2011 resulted in a downward trend in the use of a
      completion axillary lymph node dissection in early breast cancer patients with 1-2 positive
      sentinel lymph nodes (SLN), treated with wide local excision (WLE) and whole breast
      irradiation. However, there is little evidence regarding the optimal axillary treatment in
      elderly breast cancer patients, since these patients are often excluded from clinical trials.
      We had done a retrospective study of breast cancer in the elderly, which demonstrated that
      those who with complex comorbidities receiving wide local excision merely were about 1.5
      times more than those who without (71.2% vs 46.0%, p<0.001). However, it is paradoxical that,
      on the one hand, the risk of dying from breast cancer may increase if patients do not receive
      the standard treatment; on the other hand, they could not live long enough to benefit or even
      suffer more from the standard treatment. The key is to figure out who they are. Given the
      high proportion of patients treated only with WLE, we believe that it is important to compare
      the effects of different surgical procedures on prognosis among the elderly BC patient in a
      prospective cohort study, to be more specific, comparing the WLE versus any other surgical
      procedures.
observational model: Cohort
time perspective: Prospective
measure: disease free survival
time frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 72 months
description: the time interval from surgery to disease recurrence or metastasis or considered as still alive at the observation deadline or missed during follow-up
measure: overall survival
time frame: From date of surgery until the date of death from any cause, assessed up to 72 months
description: the time interval from surgery to all cause death or considered as still alive at the observation deadline or missed during follow-up
measure: breast cancer-specific survival
time frame: From date of surgery until the date of death from breast cancer related cause, assessed up to 72 months
description: the time interval from surgery to breast cancer related death or considered as still alive at the observation deadline or missed during follow-up
arm group label: 1. WLE group
description: patients in this group receiving WLE merely
arm group label: 2. other method group
description: patients in this group receiving any other surgical procedures except WLE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Qiang Sun, Professor
phone: 008613811669255
email: sunqiangpumc@sina.com
last name: Ying Zhong, Doctor
email: zhongying_pumc@163.com
facility: 
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Undecided