Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial

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

Inclusion Criteria

• Competent to sign informed consent
• Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
• 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.
• 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.
• Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than or equal to 2.
• Estrogen receptor positive, progesterone receptor positive, HER2 negative
• Age>= 50
• Breast size adequate for safe cryoablation
• Lesion must be sonographically visible at the time of treatment.
• 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

• Presence of lobular carcinoma
• Presence of luminal B pathology
• Nottingham score of 3 (specially nuclear and mitotic score>2)
• 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

Lead Organization
IceCure Medical Limited

Primary ID ICMBC-02
Secondary IDs NCI-2015-00716
Clinicaltrials.gov ID NCT02200705