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Defining an endpoint for breast cancer studies

Added: Wednesday 28 May 2014

The European Medicines Agency (EMA) is consulting on a draft guideline about the role of the pathological Complete Response (pCR) as an endpoint in neoadjuvant breast cancer studies. pCR is defined as the eradication of the tumour from both breast and lymph nodes and is associated with long-term survival. Using it as a surrogate endpoint for overall survival might be able to speed up trials of new therapies. The EMA is asking for comments on the proposals by <strong>31 July 2014</strong>.