Prospective Clinical Trial on Expanding Indications for Cryosurgery for Early Breast Cancers

This is a prospective single arm clinical trial on cryosurgery for early breast cancers, to evaluate the expanded criteria to tumors larger than 1.5 cm and non-luminal breast cancers.

Inclusion criteria include Solitary T1 breast cancers of any immunohistotypes. Cryosurgery was performed using the IceCure ProSense Cryoablation System. Lumpectomy of the cryoablated tumor was then performed 8 weeks after cryosurgery.

Fifteen patients underwent cryosurgery followed by lumpectomy (BCS). Median age was 53 years old 5 (33.3%) patients had ductal carcinoma in situ (DCIS), while 10 (66.7%) patients had invasive ductal carcinoma (IDC), of which 5 (50%) patients had luminal type cancers of which 3 (60%) were luminal A and 2 (40%) luminal B, 3 (30%) patients had HER2 enriched invasive carcinoma and 2 (20%) patients had triple negative IDC. Median tumor size was 13mm (Range 8.6-18mm). Seven (46.7%) patients were found to have residual cancer in the post-cryosurgery lumpectomy specimen. All residual cancers were found at the periphery of the cryoablated breast tissue. All breast cancers were otherwise completely ablated centrally as confirmed by routine histopathology, immunochemistry and TUNEL assay for evaluation of cell viability. None of the tumor factors such as tumor biology, as well as surgical factors such as ablation time and iceball size, were associated with risk of residual cancer. None of the 15 patients developed post-operative complications.

Residual cancer occurs at the periphery of the cryoablation site, careful pre-operative planning and intra-operative monitoring is crucial to ensure complete cryoablation.