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Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02200705
Recruitment Status : Active, not recruiting
First Posted : July 25, 2014
Last Update Posted : February 28, 2020
Information provided by (Responsible Party):
IceCure Medical Ltd.

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

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Ice-Sense3TM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)
Actual Study Start Date : October 2014
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
single arm, open label
Early stage Breast cancers up to 1.5cm
Device: Ice-Sense3TM

Primary Outcome Measures :
  1. local Inbreast Breast Tumor Recurrence (IBTR) rate. [ Time Frame: up to 5 years ]
    6 months post cryoabltion , then annually for 5 years

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02200705

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Sponsors and Collaborators
IceCure Medical Ltd.
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Responsible Party: IceCure Medical Ltd. Identifier: NCT02200705    
Other Study ID Numbers: ICMBC-02
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: March 2019
Keywords provided by IceCure Medical Ltd.:
cryoablation, cryotherapy, breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases