Sudbury is at the centre of a medical trial that could change the way breast cancer is treated across North America.
The trial for a new tool to help determine if chemotherapy is shrinking a tumour has begun in Europe, and all the test samples are being sent to RNA Diagnostics at the Health Sciences North Research Institute in Sudbury's south end for testing.
The trial, known as the Breast Cancer Response Evaluation for Individualized Therapy (BREVITY) clinical trial, accrued its first patient recently, said Dr. Amadeo Parissenti, a Laurentian University professor and chief scientific officer for RNA Diagnostics.
The tests will be performed on biopsies from 750 subjects at 40 centres in North America and Europe, including the Regional Cancer Centre in Sudbury next year.
The trial is seeking to validate the utility of the RNA Disruption Assay™ (RDA™) tool for assessing treatment efficacy 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.”
RDA is designed to test to see if chemotherapy is having the desired effect on a tumour by testing its RNA within 14 to 21 days of the first round of neoadjuvant (administered before surgery) chemotherapy to see if it is degrading, therefore killing the tumour.
Several rounds of chemotherapy lead to many side effects, including nausea and hair loss in the short term, and long-term effects like heart toxicity, infections, impaired cognition and secondary cancers.
The company is starting the testing in Europe where chemotherapy before surgery is more common practice.
“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 are using the European method, he added.
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.
With chemotherapy, it can have very positive results when it works. When it doesn't, it can be a waste of critical time and resources.
RDA, Parissenti said, will let physicians and patients know if chemotherapy is working. If it isn't, patients can move to other treatment options.
Patients are given the option of participating in BREVITY by a clinical research associate and not by their physician. There is no pressure to sign up.
“They are told this trial will not affect the outcome of their current treatment or harm it. It's their choice,” Parissenti said.
“They are already under a great deal of stress. But often (with) these trials, people sign up with the reasoning if it helps others, they are willing. It's humbling to see so many people performing a selfless act under those conditions.”
While there is a profit factor for RDA, he said there is also great potential for this to help change the way advanced breast cancer is treated in North America.
If researchers can prove it gets accurate results faster, more institutions and patients may move to the European model to enable the use of the test.
Because the company is trying to accrue many patients in several centres, the trial will likely take around two years.
“That's pretty fast for clinical trials,” Parissenti said.
RDA may predict survival rates of patients as well, although survival data will take many more years to collect.
The good news is more breast cancer patients are already surviving longer than they did in the past, meaning the window to observe their progress gets longer – up to 10 years for this tool.
“What we hope to predict early in therapy is not only whether the tumour will be destroyed after therapy, but whether the patient will have increased survival,” Parissenti explained.
Funding for the trial came from the Northern Ontario Heritage Fund Corp. (NOHFC), FedNor, and the Northern Cancer Foundation.
NOHFC funding was earmarked to install a robot in the lab to automate the tests. It isolates RNA from biopsy samples and loads it on RNA nanochipsTM as part of the RNA Disruption Assay.
That funding also helped pay for patenting fees and helped the lab meet accreditation standards.
The federal Industrial Research Assistance Program helped the company applying RDA for use with other cancers, including lymphoma, as well as help with having the lab set standard operating procedures.
RNA Diagnostics is speaking to strategic investors to help fund the trial and commercialization costs.
Parissenti said the trial alone will cost the company between $4 million and $5 million.
“Fortunately, there is a lot of interest,” he said. “They see the potential in this, and it could go a long way.”
Should RDA enter the market, they'll be on the hunt for more financing to meet demand, but they are also planning for that as well.
“We would likely start looking into making strategic partnerships with a major firm that has the global reach and use their networks,” he said, noting that Sudbury's is currently the only diagnostic lab.
“The goal then would be to establish diagnostic labs not only in Canada but in the U.S. and Europe as well.”