Unique Clinical Trial Design Accelerates Personalization of Breast Cancer Treatment

The I-SPY 2 (“Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis -2”) trial tests individual patients’ tumors for genetic or biological markers (“biomarkers”) to assess the risk of disease recurrence and screen for potential benefit from promising new treatments. In addition, an innovative trial design enables researchers to use data from one set of patients to guide decisions about which treatments might be more useful for patients later in the trial. This approach, called adaptive randomization, will help researchers learn more quickly which investigational drugs will be most beneficial for women with certain tumor characteristics and eliminate ineffective treatments more quickly.

“I-SPY 2 promises to leverage convergence of progress on a number of research fronts to speed the evaluation of promising new breast cancer drugs using molecular cancer biomarkers to identify those agents that are effective in specific subpopulations of breast cancer patients,” says Anna D. Barker Ph.D., deputy director of the National Cancer Institute and co-chair of The Biomarkers Consortium Cancer Steering Committee. “This will allow us to finally design advanced, smaller and less expensive Phase III trials that test the right drugs in the right patients.”

Georgetown Lombardi is one of 20 major cancer centers in the U.S. selected to participate in the I-SPY 2 trial. Sponsorship is provided by the Biomarkers Consortium, a unique public- private partnership managed by the Foundation for the National Institutes of Health that includes representatives from the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), and major pharmaceutical companies. Funders include the Safeway Foundation and several pharmaceutical industry partners.

“The goal of I-SPY 2 is to use an individual’s tumor characteristics to identify the most effective combination of anti-cancer agents as early in the treatment course as possible,” says the Lombardi lead investigator, Minetta Liu, M.D., director of translational breast cancer research. “At the same time, we will also be able to accelerate drug development and reduce the cost of testing medications.”

I-SPY 2 is designed for women with newly diagnosed advanced breast cancer that has not spread. About 800 women with breast cancers characterized as high-risk and fast-growing will be enrolled in the study prior to surgery. All patients will receive the current standard of care, and most participants will receive one investigational drug to see if adding another agent will lead to more significant reductions in tumor size before surgery and ultimately to more improvements in survival. A distinctive feature of the trial is that it will screen multiple drugs from multiple companies – up to 12 different agents over the course of the trial. Testing several drugs simultaneously through this adaptive design should allow the most effective ones to reach late-stage trials more quickly.

I-SPY 2 has the potential to significantly reduce the cost of drug development and bring safe and effective new drugs to market more efficiently. According to The Biomarkers Consortium, it takes over $1 billion, 12 to 15 years, and thousands of patient volunteers to get a single drug to market. I-SPY 2 was developed to allow for assessments of drug activity much earlier in the research process, potentially resulting in drug development and approval with clinical trials that require a smaller population of patients, less time and far fewer resources. The goal is to shave several years and hundreds of millions of dollars off the current process.

Five new investigational agents currently in development by three major pharmaceutical companies have already been selected for testing as part of the first phase of the trial. The agents will be donated by the companies with each agent representing a different drug class or type of chemical mechanism for attacking cancer. The first agents expected to be tested include:
• ABT-888 (veliparib), a PARP inhibitor being developed by Abbott Laboratories, Abbott Park, IL
• AMG 655 (conatumumab), an APO/TRAIL inhibitor and AMG 386, an angiogenesis inhibitor, both under development at Amgen, Thousand Oaks, CA
• CP-751,871 (figitumumab), an IGFR inhibitor and HKI-272 (neratinib), a Pan ErbB inhibitor both under
development at Pfizer, Inc., New York, NY

Click here for more information about I SPY 2 .  Patients seeking more information about this study and other clinical trials at Lombardi can call 202-444-4000.

Liu occasionally serves as a paid scientific consultant and/or scientific speaker for the following companies that are, or may be, relevant to this study: Agendia, Astra Zeneca, BiPAR / Sanofi Aventis, Bristol Myers Squibb, Genentech / Roche, GlaxoSmithKline, Novartis, and Pfizer. Liu does not own any directly purchased stock in and does not receive any direct salary or royalties from any corporate organization.

About the Foundation for the NIH
The Foundation was established by the United States Congress to support the mission of the NIH – improving health through scientific discovery. The Foundation identifies and develops opportunities for innovative public-private partnerships involving industry, academia, and the philanthropic community. A non-profit, 501(c)(3) corporation, the Foundation raises private-sector funds for a broad portfolio of unique programs that complement and enhance NIH priorities and activities. The Foundation’s Web site address is http://www.fnih.org.

About Georgetown Lombardi Comprehensive Cancer Center
Georgetown Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center and Georgetown University Hospital, seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Lombardi is one of only 40 comprehensive cancer centers in the nation, as designated by the National Cancer Institute, and the only one in the Washington, DC, area. For more information, go to http://lombardi.georgetown.edu.

About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC’s mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis — or “care of the whole person.” The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Georgetown Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO). In fiscal year 2009-2010, GUMC accounted for 79 percent of Georgetown University’s extramural research funding.



Karen Mallet (media only)
[email protected]

Categories Cancers