Prospective Phase II Multicenter Trial of Ablation after Breast Lumpectomy Added To Extend (ABLATE) Intraoperative Margins for the Sole Local Treatment of Breast Cancer.

Summary

Among 242 patients (median follow-up 44 months), eRFA after lumpectomy achieved an in-breast recurrence rate of 2.9% with re-excision <5% and good/excellent cosmesis in 89%. Pain at 6 months was markedly lower with eRFA alone versus eRFA+XRT (1.7% vs 19%), suggesting eRFA can safely replace whole-breast irradiation for selected patients.

Key Findings

• N=242; median follow-up 44 months (12–96)
• In-breast recurrence rate 2.9%; re-excision for positive margins <5%
• Good/excellent cosmesis in 89% by RTOG scales
• Breast pain at 6 months: 1.7% with eRFA alone vs 19% with eRFA+XRT (p<0.05)
• Majority avoided whole-breast radiation and mastectomy

Clinical Implications

For selected ER+PR+HER2− or DCIS tumors ≤3 cm with negative nodes, eRFA can be considered to extend margins intraoperatively and avoid whole-breast irradiation, reducing treatment burden and pain while maintaining excellent cosmesis.

Limitations

• Single-arm study without randomized comparator to standard XRT
• Selection bias and generalizability require confirmation in controlled trials

Future Directions

Randomized trials comparing eRFA versus standard whole-breast irradiation, longer-term oncologic outcomes, patient-reported outcomes, and cost-effectiveness analyses.