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OHSU Knight Cancer Institute Participates in National, Groundbreaking Clinical Trial for Breast Cancer

The I-SPY 2 Trial Could Lead to Potentially Life-Saving New Breast Cancer Drugs
The OHSU Knight Cancer Institute is one of 20 cancer centers across the country selected to participate in a groundbreaking clinical trial aimed at testing the most promising drugs in development in women newly diagnosed with higher risk, rapidly growing breast cancers.

The I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis) marks a unique public-private partnership between the National Cancer Institute (NCI), the FDA, the Foundation for the National Institutes of Health, major pharmaceutical companies and Safeway, Inc.

The I-SPY 2 trial will focus on women who are newly-diagnosed with breast cancer. These women will receive anti-cancer drugs before they have surgery to remove their tumors. In the course of the trial, breast cancer drugs in development will be tailored to the biology of each woman’s tumor using specific genetic or biological markers. Unlike conventional clinical studies, where the efficacy of a treatment is determined upon completion of a trial, I-SPY 2 is set up to continuously analyze results in real time.

“As a physician who treats breast cancer, I am incredibly excited about the I-SPY 2 study,” said Steve Chui, M.D., Director of Breast Cancer Clinical Research at the OHSU Knight Cancer Institute. “I-SPY 2 is exciting for the breast cancer care community because this revolutionary study dramatically accelerates the way that we evaluate and develop new breast cancer drugs, and brings these therapies to the people who need them. The goal of this study is to treat women with breast cancer on an individualized basis, matching the right drug to the right patients.”

All participants in the trial will receive the current optimal standard of care and most will receive one investigational drug. That novel drug will be customized for each individual tumor. The I-SPY 2 trial is also expected to further advance the concept of personalized medicine by leveraging molecular tools developed during the last decade to identify which tests should be used to determine who should be treated with which drugs.

In addition to speeding the process of bringing safe and efficient new drugs to patients, I-SPY 2 has the potential to significantly reduce the cost of drug development. Currently, it takes more than $1 billion, 12 to 15 years, and thousands of patient volunteers to get a single drug approved.  I-SPY 2 will result in the ability to identify and develop the most promising and effective drugs and in a much more targeted and timely manner. The result is fewer patients, less time and far fewer resources required to develop, and get approval for, the drugs that will save women’s lives. The goal is to shave several years and hundreds of millions of dollars off the current process.

“Compared to the slow pace of current drug development, the I-SPY 2 platform potentially can help us identify five-times as many active breast cancer drugs for one-fifth of the cost, in half the time, using half the volunteers,” adds Chui.

The national I-SPY 2 trial is expected to cost approximately $26 million over five years. Funding will come from a variety of sources, and Safeway, Inc., one of the largest food and drug retailers in North America, has stepped up as a significant non-pharmaceutical seed funder. The corporation will contribute a sizeable portion of proceeds from the Safeway Foundation’s annual chain-wide October Breast Cancer Awareness fundraising initiative to I-SPY 2.

The OHSU Knight Cancer Institute is incredibly grateful to the Safeway Foundation for its generous gift to fund its portion of the I-SPY 2 Trial. “We are thankful that Safeway has partnered with the OHSU Knight Cancer Institute and sees the potential in this unique clinical trial,” says Chui.” This gift will help deliver potentially more effective life-saving therapies to the thousands of women diagnosed with breast cancer each year. “Breast cancer research and awareness fundraising is an important tradition at Safeway,” says Dan Floyd, Director of Public Affairs and Government Relations for Safeway in Clackamas, Oregon. “The disease is a major health threat to women, and we are committed to funding programs at top cancer centers focused on leading-edge research. OHSU’s Knight Cancer Institute is a perfect fit for Safeway.”

The OHSU Knight Cancer Institute anticipates opening the I-SPY 2 Trial in the summer of 2010. For more information about the study, please visit

About the OHSU Knight Cancer Institute
With the latest treatments, technologies, hundreds of research studies and approximately 400 clinical trials, the OHSU Knight Cancer Institute is the only cancer center between Sacramento and Seattle designated by the National Cancer Institute — an honor earned only by the nation's top cancer centers. The honor is shared among the more than 650 doctors, nurses, scientists and staff who work together at the OHSU Knight Cancer Institute to reduce the impact of cancer.

About OHSU
The Oregon Health & Science University is the state's only health and research university, and Oregon's only academic health center. OHSU is Portland's largest employer and the fourth largest in Oregon (excluding government). OHSU’s size contributes to its ability to provide many services and community support activities not found anywhere else in the state. OHSU serves patients from every corner of the state, and is a conduit for learning for more than 3,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to every county in the state.
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