Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant Therapy

Study Procedure:

To perform cryoablation in this study, the doctor will insert the cryoprobe like a needle
until the tip rests in about the middle of the cancerous area. In this study, an ultrasound
imaging device will also be used to allow the doctor to see where to insert the cryoprobe.

If you are found to be eligible and agree to take part in this study, you will have an
ultrasound-guided biopsy to confirm your diagnosis. To perform an ultrasound-guided biopsy, a
tissue sample will be withdrawn from your breast using a needle and a syringe. A very small
amount of tissue will be taken. The needle is guided while being viewed by the doctor on an
ultrasound.

Cryoablation:

Before you have the cryoablation procedure, blood (about 1 teaspoon) will be drawn for
routine tests. Within 30 days after you join this study, the cryoablation procedure will be
performed. The affected area will first be numbed with anesthetic. Your study doctor will
insert the cryoprobe needle and use an ultrasound device to help guide the cryoprobe until it
reaches the cancerous area.

When in place, the cryoprobe will be used to freeze the cancerous area. The doctor will be
very careful to try to avoid damaging the surrounding normal tissue.

The cryoablation procedure will last about 20 minutes. The cryoprobe will be removed when
your doctor thinks the cancerous area has been treated as much as possible.

There will be a small wound, like a puncture wound from a large needle. Most likely, you will
not need any stitches to close this wound.

First Follow-Up Visit:

About 2-4 weeks after cryoablation:

- You will have a physical exam.

- You will have an MRI scan of the breast to check the status of the disease. This scan is
for research purposes only. Researchers want to learn if an MRI scan after cryoablation
can detect any remaining breast cancer.

Your MRI scans and the ultrasound images will be reviewed by the study radiologist. This will
include the MRI scans from before and after cryoablation, and the ultrasound images from
during cryoablation.

Surgery:

Within 4 weeks after cryoablation, you will have standard-of-care surgery to remove the
remaining area that was treated during cryoablation. You will be asked to sign a separate
consent form that describes the surgery in more detail.

After surgery, the doctor will also check to see if the cryoablation destroyed all of the
cancerous area. This will help researchers learn if cryoablation is effective.

Second Follow-Up Visit:

About 2 weeks after surgery:

- You will have a physical exam.

- You will be asked about any side effects you may have had from the cryoablation and
surgery.

When you have finished cryoablation and surgery, you and your doctor will decide if you need
additional treatment. Additional treatment is not considered part of this study. Your doctor
will be able to answer questions you may have about additional treatment.

Length of Study Participation:

You will remain on study for about 2 months. You will be taken off study early if the disease
gets worse, if intolerable side effects occur, or if you are unable to follow study
directions.

This is an investigational study. The ultrasound-guided cryoablation system that will be used
for your cryoablation procedure has been FDA-approved for use in cancer. The use of this
system for breast cancer after chemotherapy is investigational.

Up to 10 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

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 ductal carcinoma in situ (DCIS) with
microinvasion are NOT eligible. Patients with contralateral disease will remain
eligible.

2. Neoadjuvant chemotherapy or hormonal therapy for the index tumor is required.

3. Residual tumor size measure axis anti-parallel to the treatment probe. Largest size measured by mammogram,
ultrasound or MRI will be used to determine eligibility.

4. Tumor enhancement on pre-registration MRI.

5. Tumor with <25% intraductal components in the aggregate.

6. 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.

7. 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.

Exclusion Criteria:

1. History of open surgical biopsy and/or lumpectomy for diagnosis/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.

2. Pregnant and/or 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.

3. Patient has contra-indication to an MRI examination, such as clips/prostheses/implants
that are not MRI compatible, or compromised renal function, with a measured or
calculated glomerular filtration rate of 60ml/min/1.73m^2

4. Patients less than 18 years of age will not be included in this study.