MINDACT

Primary: To demonstrate the superiority of the molecular profiling approach over the usual clinical assessment in assigning adequate risk categories (and the need to receive adjuvant chemotherapy or not) to breast cancer patients with 0 to 3 positive lymph nodes. To compare a docetaxel-capecitabine regimenpossibly associated with increased efficacy and reduced long-term toxicities to existing commonly used anthracycline-based chemotherapy regimens (anthracyclines followed by docetaxel for node positive). To determine the best endocrine treatment strategy i.e. single agent up-front, aromatase inhibitor (AI) (letrozole) for seven years compared to the sequential endocrine strategy of 2 years of tamoxifen followed by 5 years of letrozole. Secondary: Comparison of the two prognostic methods: To estimate both relative (Hazard Ratio, HR) and absolute (as % at 5 years) efficacy in terms of disease free survival (DFS), distant metastasis free survival (DMFS) and overall survival (OS) of chemotherapy in the two subgroups where the clinical-pathological prognosis and the 70-gene signature molecular prognosis are discordant. To calculate overall estimates of efficacy (DFS, DMFS, OS) for each treatment strategy according to clinical-pathological prognosis and according to molecular prognosis. To estimate the percentage of patients receiving chemotherapy per each prognostic method. Gene profiling: To identify and/or validate predictive gene expression profiles of clinical response/resistance to anthracycline-based and docetaxelcapecitabine chemotherapy. The identification and validation of novel gene expression signatures predicting clinical response to sequential tamoxifen-AI versus AI alone.