Successful BR-002 trial of Novilase Breast Therapy as a laser treatment for small breast cancers- Novian Health

A laser treatment called Novilase Breast Therapy from Novian Health shows promise as a way to successfully treat small breast cancers, according to research that was led by principal investigator Barbara Schwartzberg, M.D. of Rose Medical Center. Results of the multi-center international BR-002 Novilase Clinical Trial were presented by Dr. Schwartzberg in a scientific poster at the 2015 San Antonio Breast Cancer Symposium (SABCS).

Laser ablation treatment places small probes in the center of the cancer and subsequently uses heat to destroy tumours. Laser ablation could be a viable option for small lesions and might allow some women to forgo surgery in the future. The trial results showed that Novilase Breast Therapy achieved 91% complete tumour ablation when treatment guidelines were followed. The trial also demonstrated that MRI can be used to determine effectiveness of tumour ablation. As such, MR imaging may potentially be used to assess effectiveness, as pathology is used today after surgery. The research trial, headed by Dr. Schwartzberg, is part of the process of determining whether Novilase Breast Therapy will be approved by the FDA as an effective alternative to lumpectomy surgery for the treatment of small, early-stage breast cancers. All patients in the study received standard-of-care, adjuvant and radiation therapy as indicated.

The ablated tissue was excised with surgery 4 weeks after the laser treatment to allow investigators to analyse the pathology of the targeted lesion. Researchers used that data to correlate imaging to pathology in evaluating disease status after the procedure.

Comment: If the trial results help lead Novilase Breast Therapy to becoming approved as a breast cancer treatment option, women could benefit in several ways. Rather than requiring a surgical incision, the laser device is inserted through the skin into the tumor. The incisions are so small that they are closed with a bandage after the procedure. Laser treatment causes little or no scarring or change in the breast’s shape and feel – in contrast to the substantial cosmetic and tactile impact that can result from a lumpectomy.