Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer

This is a phase II non-randomized exploratory study. All fully eligible and registered
patients will undergo imaging by mammography, ultrasound, and breast MRI. Patients will then
undergo complete surgical resection of the primary tumor. The primary and secondary
objectives of the study are described below.

OBJECTIVES:

Primary

- To determine the rate of complete tumor ablation in patients treated with cryoablation,
with complete tumor ablation defined as no remaining invasive or in situ carcinoma
present upon pathological examination of the targeted lesion

Secondary

- To evaluate the negative predictive value of MRI in the post-ablation setting to
determine residual in situ or invasive breast carcinoma

- To describe the adverse events associated with cryoablation

- To prospectively gather pain assessment data on cryoablation and surgical resection

- Explore technical variables that may affect the success of cryoablation

1. Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy.
NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral
breast cancer, multifocal calcifications, or DCIS with microinvasion are NOT
eligible. Patients with contralateral disease will remain eligible.

2. No history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment
of the index breast cancer. Note: Prior rotational and/or vacuum-assisted core
biopsies are permitted if 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.

3. Tumor size ≤ 2.0 cm in greatest diameter. Specifically, the tumor must measure ≤ 2.0
cm in the axis parallel to the treatment probe and ≤ 1.5 cm in the axis anti-parallel
to the treatment probe. Largest size measured by required scans (mammogram,
ultrasound and MRI) will be used to determine eligibility.

4. Tumor enhancement on pre-study MRI.

5. Tumor with < 25% intraductal components in the aggregate. NOTE: The percent
intraductal component from the patient's diagnostic biopsy must be available prior to
registration. If the biopsy pathology report does not contain the percent intraductal
component, then re-review of pathology slides and creation of a report addendum or
note-to-file by the reviewing pathologist will be required.

6. No prior or planned neoadjuvant chemotherapy for breast cancer.

7. Non-pregnant and non-lactating. Patients of childbearing potential must have a
negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be
amenorrheic for > 12 months to be considered not of childbearing potential.

8. Adequate breast size for safe cryoablation. Male breast cancer patients and female
breast cancer patients with breasts too small to allow safe cryoablation are not
eligible as the minimal thickness of the breast tissue does not lend itself to
cryoablation. NOTE: 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 will not contact or jeopardize the implant.

9. Patients with prior in-situ or invasive breast carcinomas are eligible if the prior
carcinomas occurred in the contralateral breast. Patients with prior in-situ or
invasive carcinomas of the ipsilateral breast are not eligible.