<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/NCT03833960</url>
  </required_header>
  <id_info>
    <org_study_id>SLNBvsALND</org_study_id>
    <nct_id>NCT03833960</nct_id>
  </id_info>
  <brief_title>SLNB After Neoadjuvant Treatment in Node Positive Patients</brief_title>
  <official_title>Impact of Sentinel Lymph Node Biopsy After Neoadjuvant Treatment on Locoregional Control of Disease in Initially Node Positive Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Hospital Center Rijeka</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Hospital Center Rijeka</source>
  <oversight_info>
    <has_dmc>No</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>
      From May 2016 till May 2018 all breast cancer patients with operable disease submitted to&#xD;
      surgery after neoadjuvant treatment would be divided in four groups considering initially&#xD;
      clinical axillary stage, axillary procedure that was done, axillary response to preoperative&#xD;
      systemic treatment and pathological axillary stage.&#xD;
&#xD;
      In first postoperative year all patients will be monitored for appearance of locoregional and&#xD;
      distant recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From May 2017 SLNB after neoadjuvant treatment was introduced in clinical practice for breast&#xD;
      cancer patients presenting initially with involved axilla but shifted to clinically negative&#xD;
      followed neoadjuvant treatment. This retrospective analysis is designed for period of one&#xD;
      year before and one year later to compare the clinical outcomes for this patients in the&#xD;
      setting where ALND was performed to the setting where SLNB was performed.&#xD;
&#xD;
      The main hypothesis was to establish that SLNB after neoadjuvant treatment, in initially node&#xD;
      positive breast cancer patients that achieve complete clinical remission following&#xD;
      neoadjuvant treatment, is reliable alternative to ALND in maintenance of locoregional control&#xD;
      of disease.&#xD;
&#xD;
      For the purpose of this trial four groups were created and the results would be compared&#xD;
      among them. In first postoperative year patients were monitored for the appearance of&#xD;
      locoregional and distant recurrence.&#xD;
&#xD;
      Data were collected individually for each patient and recorded in register. All data are&#xD;
      available to all members of investigation team, members of Ethic Committee and statistician.&#xD;
&#xD;
      Data collected in this trial would be used for publication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">May 2019</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>Regional recurrence</measure>
    <time_frame>3 years</time_frame>
    <description>All patients would be monitored in postoperative period of minimally one year for the appearance of locoregional recurrence. Results will be compared among all node negative patients (group 1 and 2) submitted to SLNB vs. ALND, and among group 2 patients only (ALND vs. SLNB).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distant recurrence (progression)</measure>
    <time_frame>3 years</time_frame>
    <description>All patients would be monitored in postoperative period of minimally one year for appearance of distant recurrence (disease progression). Results will be compared among patients from groups 2 and 4 and among group 2 patients only (ALND vs SLNB).</description>
  </primary_outcome>
  <other_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>3 years</time_frame>
    <description>To compare prolonged axillary serous secretion and arm lymphedema among patients submitted to ALND and SLNB.</description>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">65</enrollment>
  <condition>Sentinel Lymph Node Biopsy</condition>
  <condition>Locoregional Neoplasm Recurrence</condition>
  <condition>Progression, Disease</condition>
  <arm_group>
    <arm_group_label>1-cN0/pN0</arm_group_label>
    <description>Patients with initially clinically negative axilla (cN0), submitted to neoadjuvant treatment, followed by surgical procedure within ALND or SLNB was done, and the final pathological report was ypN0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2-cN+/pN0</arm_group_label>
    <description>Patients with initially clinically involved axilla (cN1-2), submitted to neoadjuvant treatment, followed by surgical procedure within ALND or SLNB was done, and the final pathological report was complete axillary remission (ypN0).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3-cN0/pN+</arm_group_label>
    <description>Patients with initially clinically negative axilla (cN0), submitted to neoadjuvant treatment, followed by surgical procedure within SLNB was done, followed by ALND because of positive pathological report of sentinel node(s).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4-cN+/pN+</arm_group_label>
    <description>Patients with initially clinically positive axilla (cN1-3) submitted to neoadjuvant treatment, followed by surgical procedure within ALND was done and the final pathological report was ypN1-3.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Groups are formed from breast cancer patients with operable disease and involved axillary&#xD;
        nodes, submitted to preoperative systemic treatment followed by surgical procedure in CHC&#xD;
        Rijeka in period from May 2016 till May 2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  operable breast cancer submitted to neoadjuvant treatment in CHC Rijeka, followed by&#xD;
             surgery in period from May 2016 till May 2018&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  T4 stage&#xD;
&#xD;
          -  inflammatory breast cancer&#xD;
&#xD;
          -  M1 stage at the time of diagnose&#xD;
&#xD;
          -  bilateral disease&#xD;
&#xD;
          -  multicentric disease&#xD;
&#xD;
          -  unavailable complete required data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>June 4, 2019</last_update_submitted>
  <last_update_submitted_qc>June 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Hospital Center Rijeka</investigator_affiliation>
    <investigator_full_name>Ana Car Peterko</investigator_full_name>
    <investigator_title>general surgeon</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>Sentinel Lymph Node Biopsy</keyword>
  <keyword>Neoadjuvant Chemotherapy</keyword>
  <keyword>locoregional recurrence</keyword>
  <keyword>distant recurrence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Recurrence, Local</mesh_term>
    <mesh_term>Disease Progression</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_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/NCT03833960
org study id: SLNBvsALND
nct id: NCT03833960
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
From May 2016 till May 2018 all breast cancer patients with operable disease submitted to
      surgery after neoadjuvant treatment would be divided in four groups considering initially
      clinical axillary stage, axillary procedure that was done, axillary response to preoperative
      systemic treatment and pathological axillary stage.

      In first postoperative year all patients will be monitored for appearance of locoregional and
      distant recurrence.
From May 2017 SLNB after neoadjuvant treatment was introduced in clinical practice for breast
      cancer patients presenting initially with involved axilla but shifted to clinically negative
      followed neoadjuvant treatment. This retrospective analysis is designed for period of one
      year before and one year later to compare the clinical outcomes for this patients in the
      setting where ALND was performed to the setting where SLNB was performed.

      The main hypothesis was to establish that SLNB after neoadjuvant treatment, in initially node
      positive breast cancer patients that achieve complete clinical remission following
      neoadjuvant treatment, is reliable alternative to ALND in maintenance of locoregional control
      of disease.

      For the purpose of this trial four groups were created and the results would be compared
      among them. In first postoperative year patients were monitored for the appearance of
      locoregional and distant recurrence.

      Data were collected individually for each patient and recorded in register. All data are
      available to all members of investigation team, members of Ethic Committee and statistician.

      Data collected in this trial would be used for publication.
observational model: Cohort
time perspective: Retrospective
measure: Regional recurrence
time frame: 3 years
description: All patients would be monitored in postoperative period of minimally one year for the appearance of locoregional recurrence. Results will be compared among all node negative patients (group 1 and 2) submitted to SLNB vs. ALND, and among group 2 patients only (ALND vs. SLNB).
measure: Distant recurrence (progression)
time frame: 3 years
description: All patients would be monitored in postoperative period of minimally one year for appearance of distant recurrence (disease progression). Results will be compared among patients from groups 2 and 4 and among group 2 patients only (ALND vs SLNB).
measure: Postoperative complications
time frame: 3 years
description: To compare prolonged axillary serous secretion and arm lymphedema among patients submitted to ALND and SLNB.
arm group label: 1-cN0/pN0
description: Patients with initially clinically negative axilla (cN0), submitted to neoadjuvant treatment, followed by surgical procedure within ALND or SLNB was done, and the final pathological report was ypN0.
arm group label: 2-cN+/pN0
description: Patients with initially clinically involved axilla (cN1-2), submitted to neoadjuvant treatment, followed by surgical procedure within ALND or SLNB was done, and the final pathological report was complete axillary remission (ypN0).
arm group label: 3-cN0/pN+
description: Patients with initially clinically negative axilla (cN0), submitted to neoadjuvant treatment, followed by surgical procedure within SLNB was done, followed by ALND because of positive pathological report of sentinel node(s).
arm group label: 4-cN+/pN+
description: Patients with initially clinically positive axilla (cN1-3) submitted to neoadjuvant treatment, followed by surgical procedure within ALND was done and the final pathological report was ypN1-3.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Clinical Hospital Center Rijeka
investigator full name: Ana Car Peterko
investigator title: general surgeon
mesh term: Neoplasm Recurrence, Local
mesh term: Disease Progression
mesh term: Recurrence