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US Launches Novel Clinical Trial to Rapidly Screen Promising Drugs for Breast Cancer Patients

By Elizabeth Fernandez, UCSF News Office | March 18, 2010

A unique national clinical trial for breast cancer -- novel in its design, collaborative scope, and ability to serve as a prototype for many other diseases -- gets underway this week at UCSF.

Called I-SPY 2, (an acronym for "Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis") the trial is designed to rapidly screen promising new drugs and match the therapy to specific biomarkers.

Under the trial's innovative path toward personalized medicine, scientists for the first time will be able to eliminate -- at an early point in the trial -- experimental drugs that show poor efficacy, dramatically shortening the time it takes to get the right medication to the right patient. In the process, drug development will be accelerated and the cost of testing medications reduced.

In collaboration with scientists from the National Cancer Institute, the U.S. Food and Drug Administration (FDA) and nearly 20 major cancer research centers across the country, the trial will involve about 800 women with high-risk, fast-growing breast cancers.

"I'm so excited that we are finally here,'' said Laura Esserman, MD, MBA, principal investigator and director of the UCSF Carol Franc Buck Breast Care Center, noting the contribution of hundreds of physicians and scientists who championed the pioneering project and helped usher it to fruition.

"Over the last 20 years, I have sat across from probably thousands of women and had to tell them that they have breast cancer," said Esserman, a UCSF breast cancer surgeon and researcher. "While it is true we have had many innovations and improvements in breast cancer treatment, the unfortunate reality is that for those women with the most aggressive cancers, they still face the stark reality that there's a significant chance they will die from the disease. We want to change that reality. I-SPY 2 is designed to change the way that we learn.''

Formally launched on Wednesday at a press conference in Washington D.C., the clinical trial is sponsored by the Biomarkers Consortium, a public-private partnership including the FDA, the National Institutes of Health, and major pharmaceutical companies led by the Foundation for the National Institutes of Health (FNIH).

"We have to ask and answer questions in cancer development more effectively,'' said UCSF Chancellor Susan Desmond-Hellmann, MD, MPH, who participated in the briefing via satellite from San Francisco. Drawing upon her previous experience ushering the advancement of life-saving cancer medications as president of Product Development at Genentech, Desmond-Hellmann said that I-SPY 2 provides a shift in paradigm for clinical trials.

"All of us have a shared sense of urgency,'' she said. "This is a great opportunity for us to see something that has never happened before.''

Read more at Elizabeth Fernandez, UCSF News Office