(SOURCE: www.ncicb.nci.nih.gov)

I-SPY 1 TRIAL: The I-SPY 1 trial started in 2003. The goal was to see if researchers could predict how a patient would respond to neoadjuvant chemotherapy (chemotherapy given to reduce tumor size, before surgery) using multiple MRI scans and biomarkers (characteristics of a cell that provide information about how the cell is behaving). Researchers didn’t use any investigational drugs in I-SPY 1. Instead, the trial involved serial imaging and tissue collection from women with tumors at least three centimeters in size.

(SOURCE: ispy2.org/about.com)

I-SPY 1 FINDINGS: Researchers found that most locally advanced breast cancers are discovered in between routine mammogram exams, which usually happen every one or two years. Therefore, investigators say women should not ignore a growing breast mass, even if there is a recent normal mammogram. Researchers also found the response to therapy and outcome can be predicted by many biomarkers.

(SOURCE: www.cancernetwork.com)

I-SPY 2 TRIAL: The second phase of the trial, I-SPY 2, was launched in March of 2010. The goal of I-SPY 2 is to take what researchers learned in I-SPY 1 and test which investigational drugs benefit patients. I-SPY 2 has the potential to reduce the costs of drug development and speed up the process of getting promising drugs to the market. The trial will screen multiple cancer drugs from multiple companies. Researchers will use the drugs and standard neoadjuvant chemotherapy to learn which new drug agents are most beneficial for women with certain tumor characteristics. They also hope to eliminate ineffective treatments more quickly. Researchers hope to test more than 800 patients over a four-year period. I-SPY 2 is still enrolling women with newly diagnosed invasive breast cancer. To find out more about how to participate visit, www.ispy2.org/about.com.

FOR MORE INFORMATION, PLEASE CONTACT:

Jackie Carr, Media Relations

University of California, San Diego

San Diego, CA

Jcarr@ucsd.edu