Testing for Sudbury--made cancer tool begins: RNA Diagnostics, Inc. announces clinical trial for breast cancer monitoring tool.

• Author: McKinley, Karen
• Position: Sudbury

Sudbury is at the centre of a medical trial that could change the way breast cancer is treated across North America.

The trial begun in Europe in May on a new tool that will help determine if chemotherapy is shrinking a tumour. All the samples are being sent for testing to RNA Diagnostics at Sudbury's Health Sciences North Research Institute.

The clinical trial, known as Breast Cancer Response Evaluation for Individualized Therapy (BREVITY), accrued its first patient recently, said Dr. Amadeo Parissenti, a Laurentian University professor and RNA's chief scientific officer.

The tests will be performed next year on biopsies from 750 subjects from 40 centres in North America and Europe, including the Regional Cancer Centre in Sudbury. The trial is seeking to validate how useful the RNA Disruption Assay[TM] (RDA[TM]) tool is in assessing treatment in the management of advanced breast cancer.

"We've just started BREVITY now, with a patient in Italy, and are working to expand the number of subjects," Parissenti said.

"Once we have enough samples from other patients, they will be sent here. We will test them and send our results to Germany. It's all blind testing, so we can keep it as accurate and ethical as possible."

The tool is designed to see if chemotherapy is having a desired effect on a tumour by testing its RNA within 14 to 21 days of the first round of neoadjuvant chemotherapy (administered before surgery) to see if it is degrading and therefore killing the tumour.

Several rounds of chemotherapy can lead to side effects, including nausea and hair loss in the short term, and heart toxicity, infections, impaired cognition and secondary cancers in the long term.

RNA is starting the testing in Europe, as chemotherapy before surgery is a more common practice there.

"The North American method is more to remove the tumour first, and mop up any lingering cancer cells in the body with chemotherapy," Parissenti explained. "Both methods have proven results, but since they are using chemotherapy before surgery in Europe, it is a better testing ground."

Some North American institutions do use the European method. Administering chemotherapy before surgery, when effective, helps the tumour shrink away from the other tissue, making it easier for surgeons to map out where to cut with minimal removal of healthy tissue.

In conjunction with chemotherapy, it can have very positive results--when it works. When it doesn't, it can be a waste of critical time and...