Dr. Esserman on the Elements of the I-SPY 2 Trial in Breast Cancer

Laura J. Esserman, MD, MBA, professor, University of California, San Francisco Helen Diller Comprehensive Cancer Center, 2018 Giant of Cancer Care^® for Cancer Diagnostics, discusses the elements of the I-SPY 2 trial in breast cancer.

There are 4 key elements of the I-SPY 2 trial, explains Esserman. First, drugs are being tested in earlier settings where there is a better potential for cure. Second, the order of therapy has been rearranged, in which efficacy is being evaluated using pathologic complete response. Previously, patients underwent surgery and went on to receive further treatment; that can impede the understanding of which drugs work well for which patients, she explains.

Third, imaging and biomarker guidance is incorporated into the trial. Investigators are using MRI imaging to evaluate a patient’s response to therapy. In addition to standard biomarkers, investigators are accounting for emerging markers of tumor biology to figure out how to best tailor therapy to each patient. The last element of the I-SPY 2 trial has reformed the historical clinical trial design by way of an adaptive trial design to enhance efficiency, says Esserman. Now, investigators do not have to rewrite a new protocol every time a new agent is brought into the trial.