How to Achieve Optimal Care in Early Breast Cancer with ‘Less' or ‘More' Treatment

and immune defenses contained in the tumor microenvironment. We believe that in the near future, breast cancer treatment will be more tailored to both the individual and the tumor. There will be more investment in trials in the neoadjuvant setting in order to identify active drugs for further clinical development and to find biomarkers of response. Another potential approach for the future will be the use of gene expression arrays. Specific gene expression signatures have been proposed to predict potential benefit form chemotherapy of extended endocrine therapy [1–9]. The ‘holy grail’ of personalized cancer care, the major ambition of current translational research, will remain elusive unless we can find ways to identify specifically those individual patients who benefit from a given systemic therapy, avoiding the risk of overtreatment. To accomplish this we require a change in the way trials are designed to investigate a new therapy or a new therapeutic approach, but we also need to confirm that the de-escalation of interventions previously regarded as standard of care in some groups of patients can be achieved without harm. What is the level of absolute benefit that is required before accepting a new therapeutic approach as a standard of care? Escalation trials are more successful than de-escalation trials. Estimating the magnitude of clinical benefit and the perceptions of appropriate efficacy-toxicity relationships to design trials will yield more relevant results in the future treatment of early breast cancer.