Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation

While RFA alone is not approved for tumor destruction in breast it is FDA-approved for ablation of soft tissue after the breast cancer is removed. This study seeks to remove the tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site instead of removing more tissue. The primary short-term goal is to obviate the need for re-excision in the event of close or positive margins (< 3 mm) which occurs on average in ~40 percent of the cases. Permanent pathology is only an estimation of margin status since 90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized margin regardless of the accuracy of the permanent pathology.

Inclusion criteria

• Female, 18-100 years old
• Not pregnant or breastfeeding
• Pre-study radiologic documentation of:
• size ≤ 5 cm
• unicentric, unilateral
• suspicious mass or calcification
• BIRADS classification ≥ IV
• location of abnormality > 1 cm from skin
• Ductal or Infiltrating Ductal Carcinoma
• Grade I-III on final pathology
• Good general health
• Zubrod Performance Status of 0,1, or 2
• No previous chemotherapy
• No palpable axillary or supraclavicular lymph nodes
• If prior non-breast malignancy, must have > 5 year disease-free survival

Exclusion criteria

• Patient < 18 y/o or > 100 y/o
• Pregnant or breastfeeding
• Male
• Breast implants
• Multicentric disease or bilateral disease
• Lesions > 5 cm in diameter
• Lesions < 1.0 cm from the skin
• Previous prior radiation to the breast
• Need for mastectomy
• Diffuse microcalcifications (as determined by the Investigator)