<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/NCT02200705</url>
  </required_header>
  <id_info>
    <org_study_id>ICMBC-02</org_study_id>
    <nct_id>NCT02200705</nct_id>
  </id_info>
  <brief_title>Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial</brief_title>
  <official_title>Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IceCure Medical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IceCure Medical Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and&#xD;
      distant recurrence of early stage breast cancer .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">August 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>local Inbreast Breast Tumor Recurrence (IBTR) rate</measure>
    <time_frame>up to 5 years</time_frame>
    <description>6 months post cryoabltion , then annually for 5 years</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete ablation of primary tumor up to 60 months after cryoablation</measure>
    <time_frame>up to 5 years from procedure date.</time_frame>
    <description>Complete ablation of primary tumor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement or maintenance of subject's quality of life</measure>
    <time_frame>at 6 months compare to the base line</time_frame>
    <description>Quality of life will be assesed using NCCN DISTRESS THERMOMETER</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast cosmetics satisfaction</measure>
    <time_frame>up to 5 years from procedure data.</time_frame>
    <description>subjects and physician satisfaction from the cosmetic results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional recurrence rate</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Regional Invasive breast tumor recurrence rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastases rate</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Distant metastases rate including contralateral Breast cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free Survival (DFS)</measure>
    <time_frame>up to 5 years</time_frame>
    <description>DFS from date of complete ablation of the primary tumor, until the first disease event where the disease event is defined as local (DCIS or invasive), regional, or distant breast cancer recurrence, second primary cancer, DCIS or invasive contralateral breast cancer, or death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Overall survival from the date of the cryoablation until the date of death from any cause or up to the 60 months follow up visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast Cancer Survival.</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Breast Cancer Survival from the date of cryoablation until the date of death from breast cancer or up to the 60 months follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>up to 2 years for AEs and up to 5 years for SAEs</time_frame>
    <description>Adverse events related to study device or procedure rate</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>single arm, open label</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Early stage Breast cancers up to 1.5cm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ice-Sense3TM/ ProSenseTM</intervention_name>
    <arm_group_label>single arm, open label</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Competent to sign informed consent&#xD;
&#xD;
          2. Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the&#xD;
             following criteria:&#xD;
&#xD;
               1. Unifocal primary disease NOTE: Patients with multifocal and/or multicentric in&#xD;
                  breast cancer, or evidence of EIC are NOT eligible. Patients with contralateral&#xD;
                  disease will remain eligible.&#xD;
&#xD;
               2. Tumor size ≤1.5 cm in greatest diameter in the axis parallel to the treatment&#xD;
                  probe AND ≤1.5 cm in the axis anti-parallel to the treatment probe AND ≤1.5 cm in&#xD;
                  Anterior/ Posterior dimension. Tumor size ≤1.5 cm in greatest diameter as&#xD;
                  measured by breast ultrasound, mammogram and/or MRI. The largest dimension&#xD;
                  measured will be used to determine eligibility.&#xD;
&#xD;
               3. Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than&#xD;
                  or equal to 2.&#xD;
&#xD;
               4. Estrogen receptor-positive, progesterone receptor-positive, HER2 negative&#xD;
&#xD;
          3. Age&gt;= 50&#xD;
&#xD;
          4. Breast size adequate for safe cryoablation&#xD;
&#xD;
          5. Lesion must be sonographically visible at the time of treatment.&#xD;
&#xD;
          6. History of previously treated ipsilateral or contralateral breast carcinoma is not an&#xD;
             exclusion criteria if the investigator is certain newly diagnosed carcinoma is new&#xD;
             unifocal primary tumor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of lobular carcinoma&#xD;
&#xD;
          2. Presence of luminal B pathology&#xD;
&#xD;
          3. Nottingham score of 3 (specially nuclear and mitotic score&gt;2)&#xD;
&#xD;
          4. Presence of microinvasion, or invasive breast carcinoma with extensive intraductal&#xD;
             component (EIC)&#xD;
&#xD;
          5. Presence of multifocal and/or multicentric in breast cancer&#xD;
&#xD;
          6. Presence of multifocal calcifications&#xD;
&#xD;
          7. Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer&#xD;
&#xD;
          8. Presence of prior en bloc open surgical biopsy and/or lumpectomy for&#xD;
             diagnosis/treatment of the index breast cancer&#xD;
&#xD;
          9. Patient that is not suitable to cryoablation procedure according to the physician&#xD;
             opinion&#xD;
&#xD;
         10. ER AND PR negative, or Her2 positive noted on pre-cryo biopsy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ironwood Cancer &amp; Research Centers</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BreastLink</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bridgeport Hospital, Yale Medical School</name>
      <address>
        <city>Trumbull</city>
        <state>Connecticut</state>
        <zip>06611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dalton Surgical Group</name>
      <address>
        <city>Dalton</city>
        <state>Georgia</state>
        <zip>30720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202-5116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Medical Imaging</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Breast Care</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CentraState Medical Center</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Breast Specialty care/ Presbyterian Hospital</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Beth Israel</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University/ NY Presbyterian hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Breast Surgeons Inc.</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University hospitals cleveland medical center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Clinic</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complete Breast Care</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cryoablation, cryotherapy, breast cancer</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/NCT02200705
org study id: ICMBC-02
nct id: NCT02200705
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and
      distant recurrence of early stage breast cancer .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: local Inbreast Breast Tumor Recurrence (IBTR) rate
time frame: up to 5 years
description: 6 months post cryoabltion , then annually for 5 years
measure: Complete ablation of primary tumor up to 60 months after cryoablation
time frame: up to 5 years from procedure date.
description: Complete ablation of primary tumor
measure: Improvement or maintenance of subject's quality of life
time frame: at 6 months compare to the base line
description: Quality of life will be assesed using NCCN DISTRESS THERMOMETER
measure: Breast cosmetics satisfaction
time frame: up to 5 years from procedure data.
description: subjects and physician satisfaction from the cosmetic results
measure: Regional recurrence rate
time frame: up to 5 years
description: Regional Invasive breast tumor recurrence rate.
measure: Distant metastases rate
time frame: up to 5 years
description: Distant metastases rate including contralateral Breast cancer
measure: Disease-free Survival (DFS)
time frame: up to 5 years
description: DFS from date of complete ablation of the primary tumor, until the first disease event where the disease event is defined as local (DCIS or invasive), regional, or distant breast cancer recurrence, second primary cancer, DCIS or invasive contralateral breast cancer, or death due to any cause
measure: Overall survival
time frame: up to 5 years
description: Overall survival from the date of the cryoablation until the date of death from any cause or up to the 60 months follow up visit
measure: Breast Cancer Survival.
time frame: up to 5 years
description: Breast Cancer Survival from the date of cryoablation until the date of death from breast cancer or up to the 60 months follow-up visit.
measure: Adverse events
time frame: up to 2 years for AEs and up to 5 years for SAEs
description: Adverse events related to study device or procedure rate
arm group label: single arm, open label
arm group type: Other
description: Early stage Breast cancers up to 1.5cm
intervention type: Device
intervention name: Ice-Sense3TM/ ProSenseTM
arm group label: single arm, open label
criteria: 
gender: Female
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms