Angela DeMichele, MD, MSCE, Assesses the Value of I-SPY2 for Neoadjuvant Treatment of Early Breast Cancer

Angela DeMichele, MD, MSCE, spoke about the I-SPY2 trial, which evaluates patients with early breast cancer who are treated with experimental neoadjuvant systemic therapy regimens.

At the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, 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, about the rationale of the phase 2 I-SPY2 platform trial (NCT01042379) investigating various experimental systemic therapy regimens in patients with early breast cancer presenting with various baseline characteristics and molecular subtypes. She highlighted how this protocol was instrumental in quickly and efficiently bringing novel therapies to patients, many of which have now been accepted as standard of care options in the space.


The I-SPY2 trial was designed over 10 years ago to evaluate new drugs in the early breast cancer setting. That was a novel idea back when we started because traditional drug development started in the metastatic setting. It’s been borne out that that is somewhat misleading in terms of how drugs can ultimately help patients. By moving evaluation of drugs to an earlier setting, we can help patients earlier and cure more patients. The trial is a platform trial, which means that we set it up and continue to run drugs through the platform. We don’t have to set up a new trial every time we want to evaluate a new drug. We’ve evaluated almost 30 drugs now over the last 10 years, and some of those are now things that are standard of care, like PARP inhibitors and immunotherapy. We were able to show in patients who were starting neoadjuvant therapy that these drugs could improve patient outcomes. Those led to phase 3 trials that now have resulted in drugs being approved as standard of care.


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