Dr Rita Nanda Discusses What Findings of I-SPY2 Mean for Future Breast Cancer Treatments

Rita Nanda, MD, associate professor, medicine, The University of Chicago Medicine, outlines the design of the I-SPY2 clinical trial and what the results have been so far.

Transcript

What is the importance of treatment innovations within patients with early stage, high-risk HER2 negative breast cancer? What role do novel agents, such as those used in the I-SPY2 phase 2 trial, have in future analyses of potential treatments?

As you know, I've been very involved in the I-SPY2 clinical trial. It is an adaptively randomized phase 2 clinical trial. It's a platform trial. So, there are arms that are entering and exiting the trial throughout the course of the trial that's been open since 2010. And most recently, pembrolizumab graduated not only for triple-negative breast cancer but for high-risk hormone receptor­­—positive breast cancer, as well.

We've already got results from the KEYNOTE-522 trial that really validated what we found in the pembrolizumab arm of I-SPY2. And it's really exciting to see that with just 29 patients with triple-negative breast cancer enrolled in the I-SPY2 trial and randomized to pembrolizumab, we were able to predict the outcome of a more than 1000 patient randomized phase 3 trial. So that's really exciting, and I think a validation of the I-SPY2 trial design and concept

What we've also seen with pembrolizumab was that it also graduated for [high-risk] hormone receptor—positive breast cancer, because there was a doubling in the pathological complete response rate for patients with hormone receptor positive HER2-negative disease, as well. And that is a subject of a currently ongoing randomized phase 3 clinical trial looking to add pembrolizumab to standard neoadjuvant chemotherapy for high-risk receptor-positive disease.