The I-SPY 2 trial aims to match experimental regimens with responding cancer subtypes. Breast cancer patients are categorized into eight biomarker subtypes, and undergo adaptive randomization within each biomarker subtype based on Bayesian statistical analysis. The goal of the adaptive randomization is for patients to receive regimens that have performed better than standard therapy.

Regimens are evaluated within 10 biomarker “signatures,” or prospectively defined combinations of biomarker subtypes. The primary endpoint is pathological complete response (pCR); tumor volume changes measured by MRI during treatment are used to predict whether a patient will have a pCR.

Regimens “graduate” from Phase II if they have a high (85% or more) Bayesian predictive probability of success in a simulated Phase III trial of neoadjuvant therapy in 300 patients in that biomarker signature, randomized in a 1:1 ratio.

The standing protocol allows new drugs to be selected for testing as others graduate. (Also see "Plexxikon's PLX3397 selected for I-SPY 2 breast cancer trial" - Scrip, 12 December, 2014.)

I-SPY 2 Helping To Normalize Adaptive Trial Designs

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