Clinical Trials /

Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial

NCT02200705

Description:

To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial
  • Official Title: Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)

Clinical Trial IDs

  • ORG STUDY ID: ICMBC-02
  • NCT ID: NCT02200705

Conditions

  • Breast Cancer

Purpose

To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .

Trial Arms

NameTypeDescriptionInterventions
single arm, open labelOtherEarly stage Breast cancers up to 1.5cm

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Competent to sign informed consent
    
              2. Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the
                 following criteria:
    
                   1. Unifocal primary disease NOTE: Patients with multifocal and/or multicentric in
                      breast cancer, or evidence of EIC are NOT eligible. Patients with contralateral
                      disease will remain eligible.
    
                   2. Tumor size ≤1.5 cm in greatest diameter in the axis parallel to the treatment
                      probe AND ≤1.5 cm in the axis anti-parallel to the treatment probe AND ≤1.5 cm in
                      Anterior/ Posterior dimension. Tumor size ≤1.5 cm in greatest diameter as
                      measured by breast ultrasound, mammogram and/or MRI. The largest dimension
                      measured will be used to determine eligibility.
    
                   3. Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than
                      or equal to 2.
    
                   4. Estrogen receptor positive, progesterone receptor positive, HER2 negative
    
              3. Age>= 50
    
              4. Breast size adequate for safe cryoablation
    
              5. Lesion must be sonographically visible at the time of treatment.
    
              6. History of previously treated ipsilateral or contralateral breast carcinoma is not an
                 exclusion criteria if the investigator is certain newly diagnosed carcinoma is new
                 unifocal primary tumor.
    
            Exclusion Criteria:
    
              1. Presence of lobular carcinoma
    
              2. Presence of luminal B pathology
    
              3. Nottingham score of 3 (specially nuclear and mitotic score>2)
    
            3. Presence of microinvasion, or invasive breast carcinoma with extensive intraductal
            component (EIC) 4. Presence of multifocal and/or multicentric in breast cancer 5. Presence
            of multifocal calcifications 6. Presence of prior or concurrent neoadjuvant chemotherapy
            for breast cancer
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:local Inbreast Breast Tumor Recurrence (IBTR) rate.
    Time Frame:up to 5 years
    Safety Issue:
    Description:6 months post cryoabltion , then annually for 5 years

    Secondary Outcome Measures

    Measure:Complete ablation of primary tumor up to 60 months after cryoablation
    Time Frame:up to 5 years from procedure date.
    Safety Issue:
    Description:
    Measure:Improvement or maintenance of subject's quality of life.
    Time Frame:at 6 months compare to the base line
    Safety Issue:
    Description:
    Measure:Breast cosmetics satisfaction.
    Time Frame:6 months after cryoablation
    Safety Issue:
    Description:
    Measure:Regional and distant Invasive breast tumor recurrence rate.
    Time Frame:up to 5 years
    Safety Issue:
    Description:
    Measure:Disease-free Survival (DFS),Overall survival including breast Cancer Survival.
    Time Frame:up to 5 years
    Safety Issue:
    Description:

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:IceCure Medical Ltd.

    Trial Keywords

    • cryoablation, cryotherapy, breast cancer

    Last Updated