Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery

This study is testing a device called the SIRA-1000 RFA system — which uses radiofrequency energy (heat) — as an additional tool during breast-conserving surgery (lumpectomy) for women with early-stage breast cancer. The goal is to help surgeons more precisely destroy any remaining cancer cells at the edges of the removed tissue. **You may be eligible if...** - You are a biological female aged 50 or older - You have a confirmed diagnosis of infiltrating ductal carcinoma (a common breast cancer type) that is hormone receptor-positive and HER2-negative - Your cancer is grade I, II, or III - You have a single tumor (unicentric, unilateral) no larger than 3 cm - The tumor is located at least 2 cm away from the skin and other structures - You are able to function reasonably well (Zubrod performance status 0–2) - You have no enlarged lymph nodes felt on exam **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are receiving neoadjuvant (pre-surgery) chemotherapy - You have a cardiac arrhythmia or active implantable medical device (e.g., pacemaker) - You have breast implants - Your cancer is in multiple spots (multicentric) or in both breasts - You have widespread calcium deposits (diffuse microcalcifications) Talk to your doctor to see if this trial is right for you.