RESPONSIFY · Genome-based biomarkers leading to validated molecular diagnostic tests for response prediction in breast cancer

Individualisation of cancer therapy based on standardized biomarker assays is one of the most demanding challenges in cancer medicine. In the RESPONSIFY consortium, we will integrate information on response prediction from different breast cancer types and methodologies into biomarker tests for targeted therapies in the clinical routine setting. Those tests will be developed for commercialisation using the expertise of the involved SMEs and industrial partners.To reach this aim, we will use different genome based strategies to identify and characterise new biomarkers as well as validate biomarkers from previous projects. Genome based strategies include new molecular techniques such as genome wide next generation sequencing, epigenetics, gene and exon expression analysis, as well as kinome arrays, in-situ proteomics and quantitative PCR using FFPE tissue. A clearly defined marker finding-training-validation-approach will be the backbone of RESPONSIFY to reach a high level of evidence for commercial diagnostic tests. The established therapy stratification criteria will be further validated within clinical trials using the expertise of the clinical study groups.The clinical study group will develop a web-based data integration and processing system to standardise integration of clinical trial data and biomarker results in one system which will be further used for clinical biomarker driven trials.Health economic characteristics of combined testing and treatment strategies will be determined to inform decision makers, using state-of-the-art cost-utility analysis. Optimising the use of current therapy options and avoiding treatments patients will predictably not respond to, may improve cost-utility parameters to levels acceptable for most health systems.For rapid evaluation of response parameters, the major focus will be on neoadjuvant therapy.The RESPONSIFY project will lead to validated tests based on formalin-fixed paraffin embedded tissue to predict resistance