| A revolution in breast cancer care is likely as we move from empirical towards molecular oncology. For Europe to lead this revolution, the Breast International Group is planning a "sister" network of excellence -TRANS-BIG- dedicated to multinational translational research linked to prospective clinical trials. At the heart of TRANS-BIG is a large, non drug-oriented, molecular-based adjuvant trial for node negative patients, preceded by a validation/standardisation phase linking the genomic analysis of frozen tumour specimens to patient outcome. These exploratory and clinical studies intend, through DNA microarray gene expression, to identify patient subgroups that could be spared toxic/expensive adjuvant treatment. Such treatment tailoring for the highest incidence cancer in women might significantly decrease its economic burden. This trial aims to prospectively validate the 70-gene poor prognosis signature identified by Dutch researchers as a potentially better discriminator of outcome than traditional clinical/pathological factors. Additionally, traditional pathology analysis and bioinformatics/statistics will be centralised, contributing to standardisation/integration within the network. In light of rapidly evolving technologies, TRANS-BIG will ensure appropriate collection and storage of patient tumour/blood samples, allowing for future analysis such as proteomics and the development of user-friendly and commercially available tools in collaboration with several European SMEs. With a dedicated Ethical-Legal Committee TRANS-BIG will comply with all national/international regulations governing such research. Spreading of excellence will be achieved in partnership with Europa Donna and FECS, the latter coordinating a traineeship programme to provide opportunities for European researchers to acquire skills in breast cancer research/associated technologies. |