Laura J. Esserman, MD, MBA
The I-SPY studies are attempting to establish a new measure of efficiency for phase II clinical trials, according to principal investigator Laura J. Esserman, MD, MBA.
State of the Science Summit™ on Breast Cancer, Esserman, a professor in the Departments of Surgery and Radiology, co-leader, Breast Oncology Program, University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, discussed the goals of the I-SPY trials and their impact thus far on patients with high-risk early breast cancer.
OncLive: What is the aim of the I-SPY trials?
: These are neoadjuvant breast cancer trials designed for women who are at very high risk for early recurrence. It is all about accelerating the pace of learning which agents are going to work for what kind of tumors, and to try to move the testing of new agents into the early-stage high-risk neoadjuvant setting instead of waiting for the metastatic setting. [We need to] test drugs where they matter most—when we can still cure people.
That is what I set out to do with my partner Nola Hylton, PhD, of UCSF, an MRI physicist who developed all the sequences for breast MRI. When she came to me with this technology back in 1993, she said, "How can we use this?" I said, "Let's use this for people who come in with these big terrible cancers, and see if we can figure out how they are responding." I did not believe that everyone was getting the same benefit. Eventually, we turned it into the I-SPY trial.
How is I-SPY altering the dynamic of clinical trials?
There are 3 or 4 key things about I-SPY. First, we are moving the drug testing earlier at a time when [patients] are curable. We hypothesized that some drugs might work even better in this setting.
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