The USC Norris Comprehensive Cancer Center is among 20 leading cancer centers in the US and Canada that will recruit and treat patients as part of a large-scale clinical trial aimed at quickly developing new breast cancer drugs.

The Biomarkers Consortium, a unique public-private partnership that includes the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and major pharmaceutical companies, led by the Foundation for the National Institutes of Health (FNIH), announced today the start of the highly anticipated I-SPY 2 Trial for breast cancer at a news conference at NIH headquarters in Bethesda, Md. I-SPY 2 is a groundbreaking new clinical trial model that will help scientists quickly and efficiently test the most promising drugs in development for women with higher risk, rapidly growing breast cancers.

"The I-SPY trial is among the most innovative and potentially informative trials testing new therapies and analyzing biological pathways that will lead to more accurate patient selection and could point the way to designing more effective drugs for breast cancer," said Debasish (Debu) Tripathy, M.D., professor of clinical medicine at the Keck School of Medicine of USC and co-leader of the Women's Cancer Program at the USC Norris Comprehensive Cancer Center.

Tripathy is the principal investigator of the study at USC, and was part of the original team that formulated the concept for the I-SPY trial along with Laura Esserman, M.D., M.B.A., Professor and Director, Carol Franc Buck Breast Care Center at the University of California, San Francisco.

The I-SPY 2 trial will employ a groundbreaking clinical trial model that uses genetic or biological markers ("biomarkers" from individual patients' tumors to screen promising new treatments, identifying which treatments are most effective in specific types of patients. In addition, an innovative adaptive trial design will enable researchers to use early data from one set of patients to guide decisions about which treatments might be more useful for patients later in the trial, and eliminate ineffective treatments more quickly.

"USC's involvement in this trial will expand the array of experimental options available to patients and contribute to this international effort," Tripathy said. "We are particularly proud that we can offer this to patients at the Los Angeles County+USC Medical Center, where many individuals who are eligible for this trial are seen and can be offered state-of-the art imaging along with new investigational agents."

I-SPY 2 has the potential to significantly reduce the cost of drug development and speed the process of bringing safe and efficient new drugs to market. Currently, it takes over $1 billion, 12 to 15 years, and thousands of patient volunteers to get a single drug to market. I-SPY 2 will allow the effectiveness of drugs to be assessed much earlier in the research process. This will result in the ability to identify and develop the most promising and effective drugs and in a much more targeted and timely manner.

Five new drugs currently in development by three major pharmaceutical companies have already been selected for testing as part of the first phase of the trial, and will be donated by the companies with each drug representing a different drug class or type of biological mechanism for attacking cancer. The first agents expected to be tested include: