COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in
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.
• Diagnosis of invasive ductal carcinoma of the breast (ER , Her-2 negative) that is grade 1 or 2 with intraductal component \<25%. Must be T1N0M0 (2 cm or less).
• If DCIS is present in the biopsy specimen it should be \<25% of the tumor and should be contiguous with the IDC. (i.e. DCIS should not be a separate tumor from the IDC).
• 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.