Some thoughts on the FDA draft guidance on the use of pCR as an endpoint for accelerated approval of treatment in high-risk early-stage breast cancer
Lu Cui, Abbvie Inc  *Bo Yang, Abbvie Inc 

Keywords: Surrogate endpoint, correlation

The FDA draft guidance (May 2012): ‘Pathologic Complete Response in Neo-adjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval’ is intended to assist sponsors in designing trials to support marketing approval of the drugs to treat breast cancer in the neo-adjuvant (preoperative) setting. In this talk, the key aspects of this guideline will be outlined. Issues and possible solutions in relation to designing such studies will be explored, and illustrated via computer simulations.