Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

PURPOSE:

To determine the rate of successful tumor ablation in patients treated with cryoablation and
endocrine therapy in a subset of patients with early stage breast cancer.

OUTLINE:

1. Core Biopsy (Pre-Registration)

2. Magnetic Resonance Imaging (Pre-Registration)

3. Tumor Cryoablation

4. Core Biopsy (Post-Cryoablation)

5. Magnetic Resonance Imaging (Post-Cryoablation)

6. Postoperative Follow-up

7. Evaluation of outcomes

Inclusion Criteria:

1. Age ≥ 50

2. Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy

3. Maximum tumor size ≤1.5 cm in its greatest diameter

4. Ultrasound visible lesion(s)

5. Clinically node negative, hormone receptor positive (+). HER2 negative (-), with <25%
intraductal component in the aggregate.

6. Unilateral or bilateral disease meeting study criteria

7. Physical and emotional ability to undergo baseline and follow-up breast MRIs and
serial breast cosmesis analysis

8. Patient agrees to receive a 5 year minimum course of endocrine therapy following
cryoablation for control of systemic disease

Exclusion Criteria:

1. Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer

2. Ductal carcinoma in-situ with microinvasions (T1mic)

3. Multifocal or multicentric invasive breast carcinoma

4. Prior or planned neoadjuvant systemic therapy for breast cancer

5. Tumor with ≥25% IDC components