Overview
This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor by freezing it. The standard approach for patients with this kind of cancer is a lumpectomy. This study will review the safety of the cryoablation procedure initially, followed by comparing cryoablation to lumpectomy in order to see if the cryoablation results in better disease control, complication rates, and quality of life.
Eligibility
Inclusion Criteria:
- Diagnosis of invasive ductal carcinoma of the breast of Luminal type A (ER/PR positive, Her-2 negative) that is grade 1 or 2 with intraductal component <25%. Must be T1N0M0 (2 cm or less).
- Oncotyping will be performed on T1b+Allred<6/8 and T1c tumors. Oncotype score in this subset of patients must be <26 to be included in the trial.
- At least 50 years of age.
- Mass must be visible on ultrasound and >5 mm from skin and chest wall muscles.
- Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria:
- Indication for neoadjuvant chemotherapy.
- Presence of BRCA 1 and/or BRCA 2 mutation.
- Prior history of breast cancer.
- Breast augmentation.
- Allergy to local anesthetics.
- Has electrical devices or implant (contraindicated for MRI).
- Pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- DCIS present beyond the proposed ablation zone on MRI, mammography, or ultrasound.
- Positive axillary lymph nodes as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure.