<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/NCT03255577</url>
  </required_header>
  <id_info>
    <org_study_id>17-384</org_study_id>
    <nct_id>NCT03255577</nct_id>
  </id_info>
  <brief_title>Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy For Locally Advanced Breast Cancer</brief_title>
  <official_title>Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients Presenting With Locally Advanced Breast Cancer: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</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>
      This study is being done to help the investigators determine how accurate the sentinel lymph&#xD;
      node biopsy (SLNB) procedure is in identifying residual cancer cells after neoadjuvant&#xD;
      chemotherapy in patients presenting with locally advanced breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 17, 2017</start_date>
  <completion_date type="Anticipated">August 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2024</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>This will be a prospective single-arm study design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Locally Advanced Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Sentinel Lymph Node Biopsy (SLNB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will undergo SLNB with dual tracer mapping using technetium-99m sulfur colloid and isosulfan blue dye, as is standard practice at our institution for cN1 patients. Than the SLNB procedure will be performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sentinel Lymph Node Biopsy (SLNB)</intervention_name>
    <description>Sentinel Lymph Node Biopsy Patients with locally advanced breast cancer will undergo SLNB with dual tracer mapping followed by completion axillary lymph node dissection.</description>
    <arm_group_label>Sentinel Lymph Node Biopsy (SLNB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients over 18 years of age with biopsy-proven breast cancer&#xD;
&#xD;
          -  Patients presenting with locally advanced disease in the breast (cT4) and/or in the&#xD;
             nodes (cN2/N3) as assessed by clinical exam and imaging&#xD;
&#xD;
          -  Patients presenting to surgery clinic after receipt of NAC at outside hospital with&#xD;
             documentation of cT4 or cN2/3 disease on initial outside physical exam and imaging&#xD;
             studies&#xD;
&#xD;
          -  Patients receiving NAC and having a nodal complete clinical response as assessed by&#xD;
             physical exam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a prior history of ipsilateral breast cancer&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients with persistent palpable axillary nodes after NAC, as assessed by physical&#xD;
             exam&#xD;
&#xD;
          -  Patients not consenting to ALND&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Barrio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrea Barrio, MD</last_name>
    <phone>646-888-5117</phone>
    <email>barrioa@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Monica Morrow, MD</last_name>
    <phone>646-888-5350</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>BAPTIST ALLIANCE - MCI (Data Collection Only)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Starr Mautner, MD</last_name>
      <phone>786-596-2000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up)</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Barrio, MD</last_name>
      <phone>646-888-5117</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Barrio, MD</last_name>
      <phone>646-888-5117</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen (Consent only and Follow Up)</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Barrio, MD</last_name>
      <phone>646-888-5117</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Barrio, MD</last_name>
      <phone>646-888-5117</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Barrio, MD</last_name>
      <phone>646-888-5117</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Barrio, MD</last_name>
      <phone>646-888-5117</phone>
    </contact>
    <contact_backup>
      <last_name>Monica Morrow, MD</last_name>
      <phone>646-888-5350</phone>
    </contact_backup>
    <investigator>
      <last_name>Andrea Barrio, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau (Consent only and Follow Up)</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Barrio, MD</last_name>
      <phone>646-888-5117</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sentinel Lymph Node Biopsy</keyword>
  <keyword>17-384</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT03255577
org study id: 17-384
nct id: NCT03255577
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is being done to help the investigators determine how accurate the sentinel lymph
      node biopsy (SLNB) procedure is in identifying residual cancer cells after neoadjuvant
      chemotherapy in patients presenting with locally advanced breast cancer.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This will be a prospective single-arm study design.
primary purpose: Treatment
masking: None (Open Label)
measure: The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer
time frame: 3 years
arm group label: Sentinel Lymph Node Biopsy (SLNB)
arm group type: Experimental
description: The patients will undergo SLNB with dual tracer mapping using technetium-99m sulfur colloid and isosulfan blue dye, as is standard practice at our institution for cN1 patients. Than the SLNB procedure will be performed
intervention type: Procedure
intervention name: Sentinel Lymph Node Biopsy (SLNB)
description: Sentinel Lymph Node Biopsy Patients with locally advanced breast cancer will undergo SLNB with dual tracer mapping followed by completion axillary lymph node dissection.
arm group label: Sentinel Lymph Node Biopsy (SLNB)
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea Barrio, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Andrea Barrio, MD
phone: 646-888-5117
email: barrioa@mskcc.org
last name: Monica Morrow, MD
phone: 646-888-5350
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Breast Neoplasms