With principal investigator Laura Esserman, MD, MBA, of the University of California, San Francisco, and co–principal investigator Donald Berry, PhD, of MD Anderson Cancer Center, I-SPY 2 will screen up to 12 different drugs in neoadjuvant therapy for breast cancer over the course of the trial. In order to do this, the trial designers received a master Investigational New Drug (IND) approval from the FDA—which allows them to graduate, drop, and add drugs seamlessly, without having to stop the trial to write a new protocol, dramatically reducing the time it takes to move from one drug to another. The simple device of having a common control arm is a major efficiency.
The focus of the trial is to match experimental drugs with tumor biomarker signatures. The trial is a prototype of personalized medicine. It is sponsored by the Cancer Biomarkers Consortium, which is a public-private partnership managed by the Foundation for the National Institutes of Health. The trial demonstrates the willingness and, indeed, the enthusiasm of pharmaceutical companies to work together to improve the speed and efficiency of cancer drug development.
Three new investigational agents currently in development have already been selected for testing as part of the first phase of the trial. These agents include:
The randomized controlled clinical trial has long been the gold standard for new cancer drugs to demonstrate worthiness of FDA approval; however, many experts contend that that our method of bringing drugs to the market is plagued by undue costs, long delays, and overregulation. According to Donald ...