Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer
Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer
This phase II trial is studying how well cryoablation therapy works in treating patients with
 invasive ductal breast cancer. Cryoablation kills tumor cells by freezing them. This may be
 an effective treatment for 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.