Draft guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies

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Download document Draft guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies
Reference number EMA/CHMP/151853/2014
Status draft: consultation open
First published 28/04/2014
Last updated 28/04/2014
Consultation start date 28/04/2014
Consultation end date 31/07/2014
Email address for submissions oncwpsecretariat@ema.europa.eu

Summary

Neoadjuvant chemotherapy is commonly used in locally advanced breast cancer (LABC) patients to facilitate breast conserving surgery (Romero et al. Annals of Oncology 24: 655-661, 2013). Currently, disease-free survival (DFS) is considered to be an appropriate endpoint for treatment effect and as a surrogate endpoint for overall survival (OS) (EMA/CHMP/205/95/Rev.4).