Dr Sara M. Tolaney on Challenges With Treating, Role of Clinical Trials in HER2-Positive Breast Cancer

Sara M. Tolaney, MD, MPH, instructor of medicine, Harvard Medical School, attending physician of medical oncology, Dana-Farber Cancer Institute, discusses challenges with managing patients with HER2-positive breast cancer and how clinical trials provide another treatment approach for these patients.

What challenges are there in the management of patients with HER2-positive breast cancer?
I think one particular challenge for patients with HER2-positive disease, unfortunately, is brain metastases. Approximately hald of all patients who develop metastatic HER2-positive disease will die from progression in the brain, and so, there have been much efforts made to try to improve outcomes for these patients. One class of drugs that we’ve focused on for this patient population has been the use of tyrosine kinase inhibitors. These agents have a lower molecular weight than monoclonal antibodies and are able to penetrate through the blood-brain barrier.

There have been several trials done looking at these agents, and a few trials would suggest that when you combine tyrosine kinase inhibitors with capecitabine, their response rates do seem to be much greater, and maybe as high as even 60%. So, now actually, the National Comprehensive Cancer Network has added it to their guidelines to consider the use of capecitabine and niratinib for patients who have progressive disease in the brain.

How do clinical trials provide another treatment approach for these patients?
I think clinical trials are a great opportunity for patients, because it allows them to get novel therapies before they get approved, and so it really gives them an opportunity to get a new agent that may have very promising activity, earlier than they would normally have access to it. So, usually when I’m seeing a patient, I like to always present what the standard option is so that they’re very well aware of what they could get outside of a clinical trial, but also discuss what the clinical trial option would be at that time and see what makes more sense at that particular moment, because it’s not always that the clinical trial is the right decision for them, and so it’s important to weigh the pros and cons of that approach.
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