Clinical trials design and treatment tailoring: general principles applied to breast cancer research.

Nowadays tailored therapy tends to replace standard cancer treatment approaches. Tailoring treatment is possible thanks to clinical trials results that identified subgroups of patients benefiting most from some treatments. Treatment can be tailored on the basis of specific clinical characteristics of the population or on the basis of predictive or prognostic markers. Finally treatment can be tailored for specific molecular targets. This evolution in cancer treatment has triggered the development of innovative trial designs to validate these new hypotheses. The real challenge of the next coming years resides in recruiting large number of patients from specific subgroups to validate tailored therapies.