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 thefollowing criteria:

3. Unifocal primary disease NOTE: Patients with multifocal and/or multicentric inbreast cancer, or evidence of EIC are NOT eligible. Patients with contralateraldisease will remain eligible.

4. Tumor size ≤1.5 cm in greatest diameter in the axis parallel to the treatmentprobe AND ≤1.5 cm in the axis anti-parallel to the treatment probe AND ≤1.5 cmin Anterior/ Posterior dimension. Tumor size ≤1.5 cm in greatest diameter asmeasured by breast ultrasound, mammogram and/or MRI. The largest dimensionmeasured will be used to determine eligibility.

5. Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be lessthan or equal to 2.

6. Estrogen receptor-positive, progesterone receptor-positive, HER2 negative

7. Age>= 50

8. Breast size adequate for safe cryoablation

9. Lesion must be sonographically visible at the time of treatment.

10. History of previously treated ipsilateral or contralateral breast carcinoma is notan exclusion criteria if the investigator is certain newly diagnosed carcinoma isnew 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)

4. Presence of microinvasion, or invasive breast carcinoma with extensive intraductalcomponent (EIC)

5. Presence of multifocal and/or multicentric in breast cancer

6. Presence of multifocal calcifications

7. Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer

8. Presence of prior en bloc open surgical biopsy and/or lumpectomy fordiagnosis/treatment of the index breast cancer

9. Patient that is not suitable to cryoablation procedure according to the physicianopinion

10. ER AND PR negative, or Her2 positive noted on pre-cryo biopsy