Accelerating identification and regulatory approval of investigational cancer drugs.

摘要

I-SPY2 was based on earlier work in I-SPY1 (CALGB150007 and 150012/ACRIN 6657), a collaboration of the Specialized Programs of Research Excellence (SPOREs) and the National Cancer Institute Cooperative Groups. Prior to starting I-SPY2, the consortium worked for several years to refine the clinical approach and surrogates for RFS at 3 years. The group also developed an infrastructure for data sharing and the methods to miniaturize molecular assays and maximize the number of assays that could be performed on small amounts of tissue. The consortium based its criteria for eligibility on the results of I-SPY 1, which shows that, in biologically high-risk8 palpable breast cancer, pCR differs by subset and is more predictive by subset than it is overall, demonstrating that the extent of outcome advantage conferred by pCR is specific to tumor biology.