<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/NCT03289195</url>
  </required_header>
  <id_info>
    <org_study_id>17-390</org_study_id>
    <nct_id>NCT03289195</nct_id>
  </id_info>
  <brief_title>Evaluate The Accuracy Of Breast MRI Biopsy In Diagnosing A Complete Tumor Response For Some Women Following Neoadjuvant Chemotherapy For Breast Cancer</brief_title>
  <official_title>A Prospective Study To Evaluate The Accuracy Of Percutaneous Breast MRI Biopsy In Diagnosing A Pathologic Complete Response Following Neoadjuvant Chemotherapy</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>
      The purpose of this study is to test the ability of a breast MRI biopsy to accurately&#xD;
      diagnose a complete tumor response to the neoadjuvant chemotherapy (NAC) that the patient&#xD;
      just finished. Numerous studies have shown that MRI has the highest accuracy for diagnosing a&#xD;
      complete tumor response. The investigator wants to see if in a certain group of women who's&#xD;
      breast cancer is no longer visible on the post-treatment MRI that the biopsy specimens from a&#xD;
      MRI guided biopsy will accurately diagnose a complete tumor response to treatment which may&#xD;
      in the future make breast surgery unnecessary in some women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</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 prospective single institution pilot study.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>estimate the negative predictive value (NPV) of a percutaneous MRI biopsy</measure>
    <time_frame>2 years</time_frame>
    <description>In this context NPV is defined as the number of true negatives (biopsy negative, i.e., no disease found on the percutaneous biopsy and pCR) divided by the number of all biopsy negatives. While NPV is of primary interest we will also estimate positive predictive value, sensitivity, and specificity of the biopsy.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>MRI biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients enrolled will have had complete MR imaging response post Neoadjuvant Chemotherapy (NAC) and will undergo percutaneous MR guided biopsy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MRI Biopsy</intervention_name>
    <description>Patient will undergo percutaneous MR guided biopsy by study Breast Radiologist within 0-60 days of completing NAC.</description>
    <arm_group_label>MRI biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women age 18 years or older&#xD;
&#xD;
          -  Confirmed histologic diagnosis of operable HER2 overexpressing (ER&lt;10%, PR&lt;10%, and&#xD;
             HER2 2+ or FISH amplified) OR triple negative (ER&lt;10%, PR&lt;10%, and HER2 0/1+ or&#xD;
             2+/FISH not amplified) OR ER positive invasive ductal or invasive lobular breast&#xD;
             cancer including MSKCC pathology confirmation&#xD;
&#xD;
          -  Operable breast cancer treated with NAC undergoing either breast conservation or total&#xD;
             Mastectomy who have had a post-NAC clinical bilateral breast MRI demonstrating a&#xD;
             complete imaging response, which is defined as no residual tumor enhancement.&#xD;
&#xD;
          -  No indication of distant metastases (M0)&#xD;
&#xD;
          -  Tumor site amenable to MRI guided biopsy as determined by the radiologist&#xD;
&#xD;
          -  Definitive surgery being performed at MSKCC within within 0-60 days of completing NAC&#xD;
&#xD;
          -  ECOG performance status score of 0 to ≤ 2 and or KPS performance status score of 80%&#xD;
             to 100%&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) must not be pregnant.&#xD;
&#xD;
          -  Women must not be breastfeeding&#xD;
&#xD;
          -  Willing and able to provide informed consent and adhere to the study visit schedule&#xD;
             and plan as specified in this protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical history and concurrent disease:&#xD;
&#xD;
               -  Prior history of treated breast cancer&#xD;
&#xD;
               -  Any underlying medical or psychiatric conditions, which in the opinion of the&#xD;
                  investigator, will make performing the study intervention hazardous or obscure&#xD;
                  the interpretation of the results&#xD;
&#xD;
          -  Prohibited Treatments and/or Therapies:&#xD;
&#xD;
               -  Prior history of breast cancer surgery and/or radiotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Breast Cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Sutton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elizabeth Sutton, MD</last_name>
    <phone>646-888-5455</phone>
    <email>suttone@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mahmoud El-Tamer, MD</last_name>
    <phone>646-888-4755</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge (All Protocol Activities)</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>Elizabeth Sutton, MD</last_name>
      <phone>646-888-5455</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth (All Protocol Activities)</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Sutton, MD</last_name>
      <phone>646-888-5455</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen (All Protocol Activities)</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Sutton, PhD</last_name>
      <phone>646-888-5455</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Sutton, MD</last_name>
      <phone>646-888-5455</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester (All Protocol Activities)</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Sutton, MD</last_name>
      <phone>646-888-5455</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</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>Elizabeth Sutton, MD</last_name>
      <phone>646-888-5455</phone>
    </contact>
    <contact_backup>
      <last_name>Mahmoud El-Tamer</last_name>
      <phone>646-888-4755</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau (All Protocol Activities)</name>
      <address>
        <city>Rockville Centre</city>
        <state>New York</state>
        <zip>11570</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Sutton, MD</last_name>
      <phone>646-888-5455</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>November 2022</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>November 23, 2022</last_update_submitted>
  <last_update_submitted_qc>November 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MRI</keyword>
  <keyword>Biopsy</keyword>
  <keyword>17-390</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/NCT03289195
org study id: 17-390
nct id: NCT03289195
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the ability of a breast MRI biopsy to accurately
      diagnose a complete tumor response to the neoadjuvant chemotherapy (NAC) that the patient
      just finished. Numerous studies have shown that MRI has the highest accuracy for diagnosing a
      complete tumor response. The investigator wants to see if in a certain group of women who's
      breast cancer is no longer visible on the post-treatment MRI that the biopsy specimens from a
      MRI guided biopsy will accurately diagnose a complete tumor response to treatment which may
      in the future make breast surgery unnecessary in some women.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This prospective single institution pilot study.
primary purpose: Diagnostic
masking: None (Open Label)
measure: estimate the negative predictive value (NPV) of a percutaneous MRI biopsy
time frame: 2 years
description: In this context NPV is defined as the number of true negatives (biopsy negative, i.e., no disease found on the percutaneous biopsy and pCR) divided by the number of all biopsy negatives. While NPV is of primary interest we will also estimate positive predictive value, sensitivity, and specificity of the biopsy.
arm group label: MRI biopsy
arm group type: Experimental
description: All patients enrolled will have had complete MR imaging response post Neoadjuvant Chemotherapy (NAC) and will undergo percutaneous MR guided biopsy.
intervention type: Procedure
intervention name: MRI Biopsy
description: Patient will undergo percutaneous MR guided biopsy by study Breast Radiologist within 0-60 days of completing NAC.
arm group label: MRI biopsy
criteria: 
gender: Female
gender based: Yes
gender description: Breast Cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth Sutton, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Elizabeth Sutton, MD
phone: 646-888-5455
email: suttone@mskcc.org
last name: Mahmoud El-Tamer, MD
phone: 646-888-4755
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: 
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