Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers

Patients with small breast cancers will undergo cryoablation of their breast cancer.
Approximately six weeks after cryoablation, definitive breast surgery will be performed.
Blood will be drawn for research before cryoablation and surgery and at regular follow-up
visits. Blood and tissue samples will be used to determine immune responses.

Inclusion Criteria:

1. Subjects with an invasive breast cancer 1.5 cm or less

2. The breast cancer must be of ductal histology, unifocal, estrogen receptor positive
and her2/neu negative.

3. The tumor must be visible by ultrasound and the subject must not have had prior
surgical resection of the primary lesion.

4. A clip marking the breast cancer must have been placed at the time of initial
diagnosis or will be placed prior to cryotherapy.

5. The breast cancer must be amenable to cryoablation (visible by ultrasound and more
than 2 mm from skin or chest wall).

6. Subjects with metastatic disease at diagnosis who elect to have their primary tumor
excised are eligible for enrollment.

7. For subjects with breast implants, the treating physician must document that adequate
distance exists between the lesion and the implant to ensure that the ablated lesion
with not contact or jeopardize the implant.

8. Subjects must be able to provide consent.

Exclusion Criteria:

1. Subjects with breast cancers of lobular histology, with lymph vascular invasion or
extensive intraductal component will be excluded.

2. Subjects with multi-centric or multi-focal breast cancers

3. Subjects with breast cancers that have invaded skin or have significant skin
tethering (assessed clinically).

4. Subjects receiving chemotherapy within one year or undergoing neoadjuvant
chemotherapy are excluded.

5. Subjects with metastatic disease at diagnosis will be excluded unless they elect
definitive surgical therapy for their primary lesion.

6. Subjects with breast cancers not amenable to cryoablation (lesions not visible by
ultrasound, against the chest wall or within 2 mm of skin) will be excluded.

7. Subjects diagnosed with another malignancy in the preceding 5 years will be excluded.

8. Subjects diagnosed with simultaneous bilateral breast cancer.

9. Subjects receiving immunosuppressive therapy within 6 months including oral steroids
will be excluded.