(This website is intended for general audiences. For patient information, please visit www.ispy2.org.)
I-SPY 2 is an Innovative public-private collaboration that combines Personalized Medicine & Novel Trial Design to develop new cancer treatments much faster and for much less cost
What Is I-SPY 2?
I-SPY 2 TRIAL is a neoadjuvant clinical trial designed to test Phase II investigational agents in combination with standard chemotherapy in a curable patient population. By employing an innovative ‘adaptive trial design’–which uses patient outcomes to immediately inform treatment assignments for subsequent trial participants—I-SPY 2 can test new treatments in half the time, at a fraction of the cost and with significantly fewer participants.
Who Should Participate?
Today most women with breast cancer receive standard chemotherapy. We know that some breast cancers respond well to this treatment but some do not. The I-SPY 2 TRIAL is a clinical trial for women with newly diagnosed, locally advanced breast cancer to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone prior to having surgery. The I-SPY 2 TRIAL will use genetic or biological markers (“biomarkers”) from individual patients’ tumors to screen promising new treatments, identifying which treatments are most effective in specific types of patients.
I-SPY 2 TRIAL Introductory Video:
I-SPY 2 is sponsored by the Biomarkers Consortium, a unique partnership led by the Foundation for the National Institutes of Health (FNIH), which includes the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and a large number of partners from major pharmaceutical companies, leading academic medical centers, and non-profit and patient advocacy groups. Funding for I-SPY 2 comes mostly from non-profit foundations, including The Safeway Foundation, and other philanthropic donors.