Sherene Loi, FRACP, Ph.D., talked to Susan G. Komen about the importance of clinical trials. Loi, a former Komen Career Catalyst Research grantee, says one clinical trial could immediately change the treatment options for metastatic breast cancer patients who have brain metastasis, a very difficult condition to treat.
Loi is an oncology professor and head of the Translational Breast Cancer Genomics and Therapeutics Laboratory at the Peter MacCallum Cancer Centre in Victoria Australia.
Komen: Clinical trials exist for a wide variety of diseases, viruses and medical conditions. Why are they so important?
Loi: All of our major medical advancements have come from clinical trials. Clinical trials are the best way to evaluate if a new therapy is effective and safe because you’re comparing it against the standard therapy, and you do that in a rigorous way. This is to ensure that we’re not biased in our results. By participating in a clinical trial, patients receive the benefit of potentially getting access to a therapy that may work better than the standard of care.
Komen: Among breast cancer patients, we know there is some hesitation about participating in clinical trials. What are some of the benefits patients can expect from participating in a clinical trial?
Loi: One benefit is the medical care that surrounds patients enrolled in clinical trials. Patients will get a dedicated team looking after them. It’s been shown that patients who are in clinical trials do really well because of that extra care that surrounds the clinical trial environment – the nurses, the research assistants and the doctors. Apart from that, you are contributing to the future of breast cancer research and potentially more cures.
Komen: Can you give me a recent example of a clinical trial that was a breakthrough for breast cancer?
Loi: The HER2Climb study evaluated a new tyrosine kinase inhibitor called tucatinib in combination with capecitabine and trastuzumab versus a placebo with capecitabine and trastuzumab. The main interest in tucatinib is its anti-tumor activity in the brain metastases, which we know is an area of great need in patients with HER2-positive metastatic breast cancer.
The study showed very promising results – the addition of tucatinib dramatically reduced the risk of disease progression. That’s a great result for breast cancer patients and particularly HER2-positive breast cancer patients who may have brain metastases as their only site of disease and have extremely poor quality of life.
Komen: Do you think the results of this clinical trial will change how HER2-positive metastatic breast cancer patients are treated?
Loi: I suspect that patients will be wanting to access this drug almost immediately. The data is very compelling, particularly since there are improvements in overall survival. The risk of dying in this study was reduced by a third if you receive standard treatment plus tucatinib or standard treatment plus placebo. The chance to live longer is a really meaningful result for patients.
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