A clinical trial is a research study that involves people. After showing promise in a lab, a clinical trial is the next step, often called the ‘bench-to-bedside’ journey. Clinical trials look at the effect of a medical action on people’s health and often compare one treatment to another. Clinical trials or studies often look at how well new treatments work and how safe they are to administer.
When it comes to breast cancer, there are trials examining every aspect of the cancer journey — from detection and diagnosis to treatment, to quality of life and the prevention of recurrence.
Here, Claire McCann, PhD, medical director of Odette Clinical Research, helps explain what questions trials are trying to answer, and gives some examples of studies that are underway.
How do we find the cancer?
Many trials are designed to investigate ways to improve how we find or detect breast cancer. This kind of trial could look at what kinds of imaging works best to find the cancer. For example, the large international T-MIST trial is comparing 3D mammography and 2D digital mammography for breast screening. Participants are randomly assigned to receive one kind of imaging or the other, after which the two methods are compared to see if one is better at catching cancer, reducing false alarms and more.
Whose cancer will be aggressive?
Some women with early stage breast cancer may never go on to develop aggressive disease, even without treatment. It’s difficult to know who is at high or low-risk. There are currently several trials using genetic sequencing in order to best determine who is at risk for an aggressive cancer and those with very low risk disease who may not require treatment at all, but who are actively monitored. This is also known as active surveillance, a management strategy that has been long established in prostate cancer, and is now a field of active research for ductal carcinoma in situ (DCIS) where there is no clear benefit of treatment. Active surveillance involves close monitoring to determine if the disease progresses at which point treatment may be required.
Duchess is a study that is evaluating a score associated with DCIS, for decisions regarding treatment approach.
How should we treat the cancer?
These types of trials examine new drugs or new combinations of drugs, novel radiation methods and new surgical techniques.
For example, at Sunnybrook a trial is currently examining the safety and efficacy of a new surgical guidance system MOLLI.
Another study is looking at high-dose, very precise radiation to treat breast tumours (Stereotactic Body Radiation Therapy) in select patients who are not good candidates for surgery. This ablative strategy is non-invasive and is completed in only four treatment sessions, minimizing the impact on the patient and hopefully the burden of their cancer treatment journey.
We also have researchers looking at tumour response to treatment in order to help personalize care. For example, one study is examining the use of quantitative ultrasound in locally advanced breast cancer patients to monitor response to chemotherapy and alter treatment plans if it is not.
Whose cancer will come back?
Can lifestyle changes reduce your risk of recurrence? Do hormone replacement therapies keep cancer at bay? Often clinical trials follow patients after their initial treatment in order to see who is at the most risk for recurrence and what can help reduce that risk.
How does cancer affect your quality of life?
Many studies also look at how having cancer impacts your life and ways to improve that. These studies might involve quality of life surveys, interviews with researchers or other lifestyle changes. For example, one clinical trial at Sunnybrook is currently look at whether prehabilitation (a form of physical activity) could help patients who are undergoing chemotherapy before surgery in terms of reducing anxiety and maximizing control over their health.
Where can I find good info about trials?