Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial

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