<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/NCT03273426</url>
  </required_header>
  <id_info>
    <org_study_id>SNUHBCC002</org_study_id>
    <nct_id>NCT03273426</nct_id>
  </id_info>
  <brief_title>Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.</brief_title>
  <official_title>Prediction of Pathologic Complete Response by Multiple Core Needle Biopsy or Vacuum Assisted Biopsy Before Surgery in Breast Cancer With Complete Clinical Response After Neoadjuvant Chemotherapy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the ability of preoperative biopsy to predict&#xD;
      correctly pathologic complete response in breast cancer patients with complete clinical&#xD;
      response after neoadjuvant chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer patients who received neoadjuvant chemotherapy and is predicted to have&#xD;
      achieved pathologic complete response (pCR) on MRI will enrolled. The enrolled patients will&#xD;
      undergo either US-guided multiple core needle biopsy or US-guided vacuum-assisted biopsy of&#xD;
      the tumor bed where it had been marked with an indicator (clip). The patient will undergo&#xD;
      subsequent wide excision of the tumor bed. Histopathologic findings of the biopsy and the&#xD;
      surgical specimen will be compared for pCR, and the ability of preoperative biopsies to&#xD;
      predict pCR will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2016</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Comparison of pathological findings for residual tumor between minimally-invasive biopsy procedure and subsequent wide excision of the biopsied area</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Negative Predictive Value</measure>
    <time_frame>2 weeks</time_frame>
    <description>Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>False Negative Rate</measure>
    <time_frame>2 weeks</time_frame>
    <description>Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Breast Neoplasm</condition>
  <arm_group>
    <arm_group_label>Core needle Biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vacuum-assisted biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Minimally-invasive biopsy</intervention_name>
    <description>Intervention (core needle biopsy (14G) or vacuum-assisted biopsy(10G)) for complete clinical response (cCR) or near-cCR predicted by MRI.</description>
    <arm_group_label>Core needle Biopsy</arm_group_label>
    <arm_group_label>Vacuum-assisted biopsy</arm_group_label>
    <other_name>vacuum-assisted biopsy</other_name>
    <other_name>core-needle biopsy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>wide excision</intervention_name>
    <description>Surgical wide excision of the biopsied area.</description>
    <arm_group_label>Core needle Biopsy</arm_group_label>
    <arm_group_label>Vacuum-assisted biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients&#xD;
&#xD;
          -  with unilateral primary cancer pathologically confirmed before neoadjuvant&#xD;
             chemotherapy (NAC)&#xD;
&#xD;
          -  who received NAC&#xD;
&#xD;
          -  with detectable lesion / clip marker on ultrasound&#xD;
&#xD;
          -  with cT1-T3 tumors&#xD;
&#xD;
          -  clinical and imaging complete or near-complete response on MRI&#xD;
&#xD;
          -  with informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multifocal cancer&#xD;
&#xD;
          -  Residual microcalcification&#xD;
&#xD;
          -  Contralateral breast cancer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wonshik Han, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <results_first_submitted>September 25, 2019</results_first_submitted>
  <results_first_submitted_qc>March 27, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 9, 2020</results_first_posted>
  <last_update_submitted>March 27, 2020</last_update_submitted>
  <last_update_submitted_qc>March 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Wonshik Han</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>Yes</sharing_ipd>
    <ipd_description>IPD including study protocol, informed consent form, clinical study report and analytic code will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Starting 6 months after publication.</ipd_time_frame>
    <ipd_access_criteria>PI will review requests for IPD.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03273426/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03273426/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Sep 2016 to Feb 2018 at Breast Care Center, Seoul National University Hospital</recruitment_details>
      <pre_assignment_details>All enrolled patients completed the protocol for minimally-invasive biopsy and subsequent wide excision.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Core Needle Biopsy</title>
          <description>Image-guided core needle biopsy (14G, ≥5 cores recommeded) for complete clinical response (cCR) or near-cCR predicted by MRI.&#xD;
The patients were assigned to either core needle biopsy or vacuum-assisted biopsy alternatively.</description>
        </group>
        <group group_id="P2">
          <title>Vacuum-assisted Biopsy</title>
          <description>Image-guided vacuum-assisted biopsy (14G, ≥5 cores recommeded) for complete clinical response (cCR) or near-cCR predicted by MRI.&#xD;
The patients were assigned to either core needle biopsy or vacuum-assisted biopsy alternatively.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Core Needle Biopsy</title>
          <description>Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.</description>
        </group>
        <group group_id="B2">
          <title>Vacuum-assisted Biopsy</title>
          <description>Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" spread="10.74"/>
                    <measurement group_id="B2" value="46.5" spread="10.03"/>
                    <measurement group_id="B3" value="49" spread="10.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor size before neoadjuvant chemotherapy</title>
          <description>Maximum tumor size on imaging in mm before neoadjuvant chemotherapy</description>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.55" spread="15.51"/>
                    <measurement group_id="B2" value="31.8" spread="12.90"/>
                    <measurement group_id="B3" value="30.68" spread="14.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Negative Predictive Value</title>
        <description>Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR</description>
        <time_frame>2 weeks</time_frame>
        <population>Number of participants with no tumor on biopsy</population>
        <group_list>
          <group group_id="O1">
            <title>Core Needle Biopsy</title>
            <description>Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.</description>
          </group>
          <group group_id="O2">
            <title>Vacuum-assisted Biopsy</title>
            <description>Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.</description>
          </group>
          <group group_id="O3">
            <title>Total</title>
            <description>Ultrasound-guided core needle biopsy + vacuum-assisted biopsy</description>
          </group>
        </group_list>
        <measure>
          <title>Negative Predictive Value</title>
          <description>Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR</description>
          <population>Number of participants with no tumor on biopsy</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.2" lower_limit="71.94" upper_limit="95.64"/>
                    <measurement group_id="O2" value="85.7" lower_limit="64.37" upper_limit="95.22"/>
                    <measurement group_id="O3" value="87.1" lower_limit="74.92" upper_limit="93.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>False Negative Rate</title>
        <description>Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Core Needle Biopsy</title>
            <description>Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.</description>
          </group>
          <group group_id="O2">
            <title>Vacuum-assisted Biopsy</title>
            <description>Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.</description>
          </group>
        </group_list>
        <measure>
          <title>False Negative Rate</title>
          <description>Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 weeks after intervention (CNB or VAB)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Core Needle Biopsy</title>
          <description>Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.</description>
        </group>
        <group group_id="E2">
          <title>Vacuum-assisted Biopsy</title>
          <description>Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>bleeding</sub_title>
                <description>post-biopsy bleeding</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>hematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Wonshik Han</name_or_title>
      <organization>Seoul National University Hospital</organization>
      <phone>+82-2-2072-1958</phone>
      <email>hanw@snu.ac.kr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03273426
org study id: SNUHBCC002
nct id: NCT03273426
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The purpose of this study is to evaluate the ability of preoperative biopsy to predict
      correctly pathologic complete response in breast cancer patients with complete clinical
      response after neoadjuvant chemotherapy.
Breast cancer patients who received neoadjuvant chemotherapy and is predicted to have
      achieved pathologic complete response (pCR) on MRI will enrolled. The enrolled patients will
      undergo either US-guided multiple core needle biopsy or US-guided vacuum-assisted biopsy of
      the tumor bed where it had been marked with an indicator (clip). The patient will undergo
      subsequent wide excision of the tumor bed. Histopathologic findings of the biopsy and the
      surgical specimen will be compared for pCR, and the ability of preoperative biopsies to
      predict pCR will be evaluated.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Comparison of pathological findings for residual tumor between minimally-invasive biopsy procedure and subsequent wide excision of the biopsied area
primary purpose: Diagnostic
masking: None (Open Label)
measure: Negative Predictive Value
time frame: 2 weeks
description: Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR
measure: False Negative Rate
time frame: 2 weeks
description: Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR
arm group label: Core needle Biopsy
arm group type: Experimental
description: Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
arm group label: Vacuum-assisted biopsy
arm group type: Experimental
description: Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
intervention type: Procedure
intervention name: Minimally-invasive biopsy
description: Intervention (core needle biopsy (14G) or vacuum-assisted biopsy(10G)) for complete clinical response (cCR) or near-cCR predicted by MRI.
arm group label: Core needle Biopsy
arm group label: Vacuum-assisted biopsy
other name: vacuum-assisted biopsy
other name: core-needle biopsy
intervention type: Procedure
intervention name: wide excision
description: Surgical wide excision of the biopsied area.
arm group label: Core needle Biopsy
arm group label: Vacuum-assisted biopsy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wonshik Han, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Wonshik Han
investigator title: Professor
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: IPD including study protocol, informed consent form, clinical study report and analytic code will be shared.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Starting 6 months after publication.
ipd access criteria: PI will review requests for IPD.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 