Protocol Number

Patient ID

Patient Initials (L F M)

Institution Number

Institution

Are data amended (if data are amended, please circle in red when using paper form)

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. NOTE: Results of ER, PR, HER-2/neu and Oncotye DX if needed must be obtained on pre-registration needle core biopsy material. See Testing Guidelines Section 3.1)

No history of rotational vacuum assisted core biopsies; en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer

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 mammogram, ultrasound or 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)

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)

Patient consented to optional blood sample collection

Patient's Initial Consent given for blood specimen use for research on the patient's cancer?

Patient's Initial Consent given for blood specimen use for research unrelated to the patient's cancer?

Patient's Initial Consent given for tissue specimen use for research on the patient's cancer?

Patient's Initial Consent given for tissue specimen use for research unrelated to the patient's cancer?

Patient consented to allow an ACOSOG representative to contact patient in the future to take part in more research

MedDRA Code (10006285 [Breast cancer, NOS])

Primary Site (Tumor Breast)

Histologic Type (check one)

Other specify

Nuclear Grade (check one)

Date of core needle biopsy (mm/dd/yyyy)

Needle gauge

Biopsy clip placed at time of biopsy (check one)

Name of biopsy clip

% Intraductal component (DCIS %)

HER2 results/IHC (check one)

HER2 results/FISH (check one)

Date (mm/dd/yyyy)

Date (mm/dd/yyyy)

ER Status (check one)

PgR Status (check one)

Pregnancy test done (check one)

Reason pregnancy test not performed (If no check one)

Other, specify

Date of Onset of Most Recent Menstrual Period (mm/dd/yyyy)

Date (mm/dd/yyyy)

Date (mm/dd/yyyy)

Not Applicable (Patient is post-menopausal)

Is oncotype analysis planned (check one)

Is adequate tumor volume present (If yes check one)

Date of Ultrasound (mm/dd/yyyy)

Dimension 2 (Tumor size width cm)

Dimension 2 (Tumor size width cm)

Dimension 3 (Tumor size depth cm)

Dimension 3 (Tumor size depth cm)

Date of mammogram (mm/dd/yyyy)

Dimension 1 (Tumor size length cm)

Dimension 1 (Tumor size length cm)

Calcifications (check one)