Phase II study on radiofrequency ablation in early breast cancer.

e12536Background: Recent advances of screening mammography and primary chemotherapy make it possible to identify small size of breast cancer (BC) and minimize surgical management. Previously we reported the result of radiofrequency ablation (RFA) immediately followed by breast-conserving surgery (BCS) in 30 patients with T1N0 BC (Breast, 18:130-4, 2009). Complete ablation was found in 26 patients (87%) from the pathological diagnosis of tumor specimens stained with hematoxylin–eosin and nicotinamide adenine dinucleotide diaphorase. Thus, we conducted a phase II study to evaluate the safety and reliability of RFA alone in BC (UMIN000020805). Methods: T1 and sentinel node-negative BC patients were eligible. BC with diffuse calcification or extensive intraductal component (EIC) was excluded. RFA was performed using a LeVeen needle electrode system (Boston Scientific Corporation, USA). Primary endpoint was breast deformity due to RFA, which was calculated from ratios of the length from nipple to several point...