Impact of I-SPY 2 TRIAL

It is absolutely critical that the timeframe for evaluating new agents for breast cancer is shortened and that the most promising agents are delivered to those most likely to benefit. Introducing these agents in the neoadjuvant setting, where there is a short-term (six-month) intermediate endpoint to approximate efficacy, will provide the proper time horizon for agent evaluation. Furthermore, the introduction of these agents to women with curable high-risk disease carries the promise of improving survival rates in women most at risk of death due to their disease.

However, the classic randomized trials evaluating one drug at a time for a set number of individuals is still inefficient, and does not allow rapid learning about patients for whom the new agents are most effective. The adaptive design of I-SPY 2 TRIAL will address this issue, allowing drugs to be targeted efficiently to patients in which they will be effective.

Significantly, I-SPY 2 provides an infrastructure and process for the efficient evaluation of new drugs and biomarker profiles. Thus, the deliverables from the successful conduct of I-SPY 2 will be an efficient process for evaluating new drugs and biomarkers, as well as information on the response of LABCs with specific biomarker profiles to drugs representing several mechanistic classes. Data will be gathered to qualify the use of MR Volume change as an early endpoint for predicting response to therapy; MR Volume change could then be used in future adaptive design studies as an earlier basis for drug randomization than pCR.

It is expected that these benefits will begin to be realized with the graduation of the first drug from the study, which is anticipated to occur less than two years after the clinical trial is initiated. From that point through the completion of the study, results will be published continually as evaluation of drugs and biomarkers are completed.