<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/NCT03789851</url>
  </required_header>
  <id_info>
    <org_study_id>MIB001</org_study_id>
    <nct_id>NCT03789851</nct_id>
  </id_info>
  <brief_title>Minimally Invasive Biopsy Predicting Breast pCR After NAC for Breast Cancer</brief_title>
  <acronym>MIBPBPCR</acronym>
  <official_title>Minimally Invasive Biopsy Technique Predicting Breast Pathological Complete Respons After Neoadjuvant Chemotherapy for Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong Cancer Hospital and Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong Cancer Hospital and Institute</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>
      Neoadjuvant chemotherapy (NAC) is widely used as an efficient breast cancer treatment.&#xD;
      Ideally, a pathological complete remission (pCR) can be achieved. With improvements in&#xD;
      molecular typing guided NAC and targeted therapies, there has been dramatic improvement in&#xD;
      pCR rates, especially among triple-negative and human epidermal growth factor receptor 2&#xD;
      positive breast cancers. Rates of pCR in these groups of patients can reach 60% or higher.&#xD;
      NAC has significantly promoted the loco-regional de-escalating treatment of breast cancer,&#xD;
      and the need for breast surgery in NAC cases with pCR has been questioned, especially in&#xD;
      patients undergoing breast-conserving surgery with whole breast radiotherapy. The main&#xD;
      impediments for potential elimination of breast surgery have been the fact that conventional&#xD;
      and functional breast imaging techniques are incapable of accurate prediction of residual&#xD;
      disease. However, imaging-guided minimally invasive biopsy (MIB) techniques might have the&#xD;
      potential to overcome this impediment.&#xD;
&#xD;
      The investigators design and begin a prospective one-armed clinical study to explore the&#xD;
      accuracy of MIB in predicting breast pCR after NAC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In clinical routine surgical treatment follows the neoadjuvant chemotherapy (NAC). However,&#xD;
      recent studies have demonstrated that shrinking tumors need less surgical treatment&#xD;
      indicating that patients with pCR could potentially be spared of surgery in the future.&#xD;
      However, up to now, prediction of pCR after NACT is only moderately accurate. This&#xD;
      prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (MIB)&#xD;
      might overcome this diagnostic challenge.&#xD;
&#xD;
      From June 1st, 2017 to June 15th, 2019 the investigators performed ultrasound-guided&#xD;
      multipoint core needle biopsy (CNB) on 50 breast cancer patients after NAC and directly after&#xD;
      surgery. To analyse CNB pathologically results were categorized as follows: residual vital&#xD;
      tumor cells (invasive, in situ, both, lymphangiosis carcinomatosous) present, (significant&#xD;
      parts of) the tumor bed present, neither vital tumor cells nor (significant parts of) the&#xD;
      tumor bed (indicating a non representative VAB). The results were compared to those of the&#xD;
      pathological examination of surgical specimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2019</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>false negative CNB results，reported as the false negative rate (= FNR)</measure>
    <time_frame>after breast surgery, up to 2 weeks after CNB</time_frame>
    <description>non-detected residual tumor by CNB (=index test) compared to breast surgery (=reference test): FNR = rate of patients with non-detected residual tumor by CNB compared to breast surgery Residual tumor is defined as a positive result; in surgical specimen as well as in CNB.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>negative predictive value (NPV)</measure>
    <time_frame>after breast surgery, up to 2 weeks after CNB</time_frame>
    <description>The negative predictive value (NPV) will be calculated as the quotient of the number of cases with pCR in CNB and in surgical specimen (= true negative result), divided by the total number of cases with pCR in CNB. Residual tumor is defined as a positive result; in surgical specimen as well as in CNB.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>core needle biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients enrolled in this study received a ultrasound-guided multipoint core needle biopsy after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>core needle biopsy</intervention_name>
    <description>Because the ultrasound was unable to accurately position the marker clip, I125 coud be placed at the position of the marker clip under the guidance of preoperative mammography. The gamma detector was used to locate the tumor bed to guide the ultrasound-guided multi-point CNB. Ultrasound-guided multipoint CNB was used directly after breast conserving surgery or mastectomy. Centering on the marker clip, the range of 0.5 cm was the first area, and then the range of 0.5 cm was the second area, and so on, until the extent of the expansion reached the long diameter of the original tumor, and 4 pieces were uniformly taken in each area.</description>
    <arm_group_label>core needle biopsy</arm_group_label>
    <other_name>ultrasound-guided multipoint core needle biopsy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  after full-course neoadjuvant chemotherapy (NAC) according to the NACT protocol&#xD;
&#xD;
          -  with cT1c-cT4a-c tumors&#xD;
&#xD;
          -  after informed consent&#xD;
&#xD;
          -  with breast ultrasound, mammography (and breast MRI where necessary) before and after&#xD;
             NACT&#xD;
&#xD;
          -  Clinical / imaging partial or complete response to NAC&#xD;
&#xD;
          -  Any routine breast cancer surgical intervention planned according to guidelines&#xD;
             (breast conservation or mastectomy)&#xD;
&#xD;
          -  Residual intramammary target lesion or clip marker is visible in ultrasound and / or&#xD;
             mammography&#xD;
&#xD;
          -  Inclusion of only one breast per patient, in bilateral cancer one breast can be&#xD;
             included&#xD;
&#xD;
          -  In case of multicentric disease: confirmation of the same tumorbiological subtype&#xD;
             defined by immunohistology in at least 2 lesions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Palliative or recurrent breast cancer&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  cT4d stage (inflammatory breast cancer)&#xD;
&#xD;
          -  M1 stages&#xD;
&#xD;
          -  stable disease according to a multimodal assessment of ultrasound, mammography and&#xD;
             breast MRI (if available) according to RECIST&#xD;
&#xD;
          -  dislocation of marker (&gt; 10mm distance to the initial lesion)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yong-sheng Wang</last_name>
    <phone>+86 0531-67626213</phone>
    <email>wangysh2008@aliyun.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University</name>
      <address>
        <city>Jinan</city>
        <zip>250117</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yong-sheng Wang</last_name>
      <phone>+86 676-26213</phone>
      <email>wangysh2008@aliyun.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 28, 2018</last_update_submitted>
  <last_update_submitted_qc>December 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong Cancer Hospital and Institute</investigator_affiliation>
    <investigator_full_name>Yongsheng Wang</investigator_full_name>
    <investigator_title>Director of the Breast Cancer Center</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>
  <!-- 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/NCT03789851
org study id: MIB001
nct id: NCT03789851
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neoadjuvant chemotherapy (NAC) is widely used as an efficient breast cancer treatment.
      Ideally, a pathological complete remission (pCR) can be achieved. With improvements in
      molecular typing guided NAC and targeted therapies, there has been dramatic improvement in
      pCR rates, especially among triple-negative and human epidermal growth factor receptor 2
      positive breast cancers. Rates of pCR in these groups of patients can reach 60% or higher.
      NAC has significantly promoted the loco-regional de-escalating treatment of breast cancer,
      and the need for breast surgery in NAC cases with pCR has been questioned, especially in
      patients undergoing breast-conserving surgery with whole breast radiotherapy. The main
      impediments for potential elimination of breast surgery have been the fact that conventional
      and functional breast imaging techniques are incapable of accurate prediction of residual
      disease. However, imaging-guided minimally invasive biopsy (MIB) techniques might have the
      potential to overcome this impediment.

      The investigators design and begin a prospective one-armed clinical study to explore the
      accuracy of MIB in predicting breast pCR after NAC.
In clinical routine surgical treatment follows the neoadjuvant chemotherapy (NAC). However,
      recent studies have demonstrated that shrinking tumors need less surgical treatment
      indicating that patients with pCR could potentially be spared of surgery in the future.
      However, up to now, prediction of pCR after NACT is only moderately accurate. This
      prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (MIB)
      might overcome this diagnostic challenge.

      From June 1st, 2017 to June 15th, 2019 the investigators performed ultrasound-guided
      multipoint core needle biopsy (CNB) on 50 breast cancer patients after NAC and directly after
      surgery. To analyse CNB pathologically results were categorized as follows: residual vital
      tumor cells (invasive, in situ, both, lymphangiosis carcinomatosous) present, (significant
      parts of) the tumor bed present, neither vital tumor cells nor (significant parts of) the
      tumor bed (indicating a non representative VAB). The results were compared to those of the
      pathological examination of surgical specimen.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: false negative CNB results，reported as the false negative rate (= FNR)
time frame: after breast surgery, up to 2 weeks after CNB
description: non-detected residual tumor by CNB (=index test) compared to breast surgery (=reference test): FNR = rate of patients with non-detected residual tumor by CNB compared to breast surgery Residual tumor is defined as a positive result; in surgical specimen as well as in CNB.
measure: negative predictive value (NPV)
time frame: after breast surgery, up to 2 weeks after CNB
description: The negative predictive value (NPV) will be calculated as the quotient of the number of cases with pCR in CNB and in surgical specimen (= true negative result), divided by the total number of cases with pCR in CNB. Residual tumor is defined as a positive result; in surgical specimen as well as in CNB.
arm group label: core needle biopsy
arm group type: Experimental
description: All patients enrolled in this study received a ultrasound-guided multipoint core needle biopsy after surgery.
intervention type: Device
intervention name: core needle biopsy
description: Because the ultrasound was unable to accurately position the marker clip, I125 coud be placed at the position of the marker clip under the guidance of preoperative mammography. The gamma detector was used to locate the tumor bed to guide the ultrasound-guided multi-point CNB. Ultrasound-guided multipoint CNB was used directly after breast conserving surgery or mastectomy. Centering on the marker clip, the range of 0.5 cm was the first area, and then the range of 0.5 cm was the second area, and so on, until the extent of the expansion reached the long diameter of the original tumor, and 4 pieces were uniformly taken in each area.
arm group label: core needle biopsy
other name: ultrasound-guided multipoint core needle biopsy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yong-sheng Wang
phone: +86 0531-67626213
email: wangysh2008@aliyun.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong Cancer Hospital and Institute
investigator full name: Yongsheng Wang
investigator title: Director of the Breast Cancer Center
mesh term: Breast Neoplasms