The I-SPY Consortium was formed in 2007 by breast cancer physicians and researchers with a goal of accelerating the development of biologically targeted therapies for breast cancer treatments, establishing more patient-centric trials and harmonizing our approaches to clinical care and research. The consortium adopted the following five points as foundations of the I-SPY approach: 1. Moving initial drug development in breast cancer to early breast cancer where cure is possible, breaking with the tradition of testing in the early setting only after testing in metastatic disease. 2. Using neoadjuvant treatment in which systemic therapy is given before surgery, and which allows assessment of a tumor’s response to treatment. 3. Using MRI as a cornerstone technology to establish real-time, non-invasive measures of treatment response. 4. Focusing on early endpoints as a means to accelerate clinical development. 5. Developing and implementing novel trial designs that accelerate precision medicine and advance patient-oriented research.