A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the
following criteria:

- Unifocal primary disease

- Tumor size ≤ 2.0 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

- Tumor enhancement on baseline MRI

- Tumor with < 25% intraductal components in the aggregate

- Breast size adequate for safe cryoablation

- For patients 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

- No lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer,
multifocal calcifications, ductal carcinoma in situ (DCIS) with microinvasion, or
invasive breast carcinoma

- Contralateral disease allowed

- HER2/neu status and Oncotype DX status (if needed) known

- Hormone receptor status:

- Estrogen receptor and progesterone receptor status known

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- Not pregnant or nursing

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

- No prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of
the index breast cancer

- Prior rotational and/or vacuum-assisted core biopsies allowed provided that no
significant distortion is seen on imaging that could obscure visualization and
detection of residual disease on MRI, or visualization of cancer on ultrasound
for cryoablation procedure

- No prior or concurrent neoadjuvant chemotherapy for breast cancer