In the EORTC 10994 study, pre-chemotherapy samples were collected and have already conducted to some research projects and publications (J Pathol. 2013 Dec;231(4):441-8 / Pharmacogenomics J. 2014 Jun 24). A recent project proposal (called LINE) will concentrate on luminal tumours (ER positive and HER2-negative). It is hypothesized that it is the genomics of the residual disease that will both identify the cancer cells resistant to chemotherapy and the molecular pathways that may offer additional therapeutic opportunities in future trials. The primary objective of the LINE project will be to identify mutations (using NGS) which are predictive for relapse-free interval (RFI) from tumours which did not achieve a pCR after neoadjuvant chemotherapy. For this, pre and post-chemotherapy formalin fixed samples have been collected. A panel of 360 cancer genes will be sequenced plus recurrently rearranged introns of 20 genes involved in frequent fusion genes in solid tumours and genome-wide SNP tiling for copy number analysis will be performed in collaboration with the Sanger Institute.
In the EORTC 10041 trial (MINDACT), mandatory fresh tumor samples for microarray analysis were stored for proteomic analysis. Representative paraffin tissue block samples have been collected for central histopathology review and for the production of tissue microarrays. Optional blood sample collection (whole blood and serum) has been performed for genetics and proteomics analyses and bank storage for future research projects. Several publications have resulted already from this large collection of biological material. After publication of the primary end-point of the study, there will be opportunities for external partners to request material for research proposals, in accordance with the study policy for access to material (available here).