Date of Birth (month day year)

Gender of a Person

Ethnicity

Country of Residence

Zip code

Race

Method of Payment

Pt ID# (Local Patient Identifier)

Last (initial)

First (initial)

Middle (initial optional)

E-mail (for Registration Confirmation)

Has patient previously been registered to an ACOSOG study

Coordinating Group Patient ID (if yes previously issued ACOSOG Patient ID)

Date Informed Consent Signed (month day year)

Was HIPAA Authorization included in Study Informed Consent

HIPAA Authorization Date (If no month day year)

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

No history of en bloc 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.)

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.)

Tumor enhancement on pre-study MRI

Tumor with < 25% intraductal components in the aggregate

No prior or planned neoadjuvant chemotherapy for breast cancer

Non-pregnant and non-lactating (Patients of childbearing potential must have a negative serum or urine pregnancy test. Note: Peri-menopausal women must be mernorrheic for >12 months to be considered not of childbearing potential. If not a woman of childbearing potential or male mark NA)

Negative pregnancy test date (If a woman of childbearing potential serum or urine mm/dd/yyyy)

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. 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.)

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