Angela DeMichele, MD, MSCE, Talks Changes to the Treatment Paradigm Resulting From I-SPY2 in Early Breast Cancer


Angela DeMichele, MD, MSCE, discussed how the standard of care can be shifted based on the results of the phase 2 I-SPY2 trial investigating novel neoadjuvant treatment strategies in early breast cancer.

CancerNetwork® spoke with Angela DeMichele, MD, MSCE, co-leader of the Breast Cancer Research Program, co-director of 2-PREVENT Breast Cancer Translational Center of Excellence, and Alan and Jill Miller Professor in Breast Cancer Excellence at Penn Medicine in Philadelphia, at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting about how the results from the phase 2 I-SPY2 trial (NCT01042379) have changed the treatment landscape in the neoadjuvant management of early breast cancer. She sees current and future results driving the field toward a truly precision-based strategy within the foreseeable future.


Finding these signals [enables us] to understand which patients can best respond to the treatments we have available right now. That new classification enables us to do personalized profiling, which has an application for the drugs we have already. I expect that that will be adopted over time and change our thinking about what kind of breast cancer a patient has. It’s not just 3 [subtypes] anymore. There are lots of subtypes, and we’ve got to match our treatments to that. That will be the way in which we use these tools every day with standard therapy. The other [advantage of I-SPY2] is to be able to define these new signals with novel drugs and figure out how we can best utilize new classes of drugs, such as antibody-drug conjugates, immunotherapy, and new types of endocrine therapy, not just tested in everyone but tested in the patients whose tumors are most likely to respond. When we do that, we can find the drugs that are going to move the needle. Our goal is to find the game changers. We saw data [at 2022 ASCO] about treatment of patients who have a low level of HER2 expression and that’s something we were testing in I-SPY2. Now if a patient comes to us and they have low-level HER2, we’ll be able to factor that into the initial treatment. We can modify the personalization on an ongoing basis, identify new drugs that are going to have a big effect, and then move that out into larger trials that can change the standard of care.

Our patients have been telling us that they expect this, they need this, they want this. We’ve worked with many patient advocates on this trial who have helped us figure out how to get from that being just a pipe dream to how we do this in real time. A big component of that is developing educational tools and decision tools to help patients work with their providers to understand profiling and realize that they now have several decisions they can make based on this. It’s a real partnership with patients to finally deliver on what we had promised a decade ago, which was to get to precision therapy. I am excited because I think precision therapy will be the standard within my lifetime. We are right there on the verge, and I think you’re seeing that more and more.


Huppert LA, Rugo HS, Pusztai L, et al. Pathologic complete response (pCR) rates for HR+/HER2- breast cancer by molecular subtype in the I-SPY2 Trial. J Clin Oncol. 2022;40(suppl 16):504. doi:10.1200/JCO.2022.40.16_suppl.504

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