Frequently Asked Questions
What problem is being addressed by I-SPY 2?
The process of developing cancer drugs is prohibitively expensive and prone to failure. It currently requires well over $1 billion, 12-15 years, and the involvement of 1,000 to 6,000 patient volunteers to bring one drug to market. Despite this high cost, historically, 60% of drugs do not pass the clinical trials process. This very high hurdle for drug development results in many treatments not being made available to patients who need them.
What will be the benefit of I-SPY 2?
I-SPY 2 is an unprecedented approach to clinical trials designed to SIGNIFICANTLY reduce the cost, time and number of patients required to bring new drugs to patients who need them. Utilizing an innovative adaptive trial design (which uses patient outcomes to immediately inform treatment assignment for subsequent trial patients), I-SPY 2 can safely test some of the most promising treatments in half the time, at a fraction of the cost and with significantly fewer patients. This unprecedented collaborative research effort uses genetic and biological markers (biomarkers) from individual patients’ tumors to screen several promising new treatments simultaneously and allows doctors to quickly measure the effectiveness of the treatment prior to removing the tumor. I-SPY 2 represents a true paradigm shift in breast cancer research and has very promising implications for other cancers as well.
Why is this trial unprecedented?
There are several key transformative concepts in this clinical trial. First, we use an adaptive trial design which utilizes the outcome information from each patient as she goes through the study to help in treating the next patient. Second, we personalize treatments within predefined subsets of the disease—based on the patient’s tumor’s profile—so that patients are assigned targeted therapies that are performing better within their subset. Third, we are testing multiple drugs within the same overall trial, so we are more likely to come out with more than one successful treatment that can graduate to a Phase III trial. Fourth, we have changed the order of therapy and are administering the chemotherapy neoadjuvantly, i.e., prior to surgery, and then using MRI in order to track the response of the tumor to the treatment before removing the evidence. Finally, we fine-tune the primary endpoint by considering residual tumor burden at the time of surgery, correlating this with longer-term outcomes of relapse-free and overall survival.
How does the trial work?
I-SPY 2 will involve 800 female breast cancer patients whose cancers are locally advanced and therefore at the highest risk of progression. Patients will accrue at 20+ clinical study sites around the U.S. and potentially in Canada. The I-SPY 2 sites include:
Who is supporting this trial?
I-SPY 2 is a unique public/private partnership and collaboration between the Foundation for the National Institutes of Health Biomarkers Consortium, the Food and Drug Administration (FDA), the National Cancer Institute (NCI), 20 leading academic cancer research centers (researchers and physicians), the Safeway Foundation, QuantumLeap Healthcare Collaborative and patient advocates.
What is the status of the Trial?
Since the trial launched in March 2010, 20+ trial sites have opened for enrolling patients, and more sites will be opening soon. Interest from participating trial sites is very high.
