Cancer treatment and monitoring through identification of circulating tumour cells and tumour related nucleic acids in blood

This consortium aims to validate technologies for CTCs, cfDNA and circulating microRNAs as blood-based biomarkers to determine the absence/presence of drug targets and/or assess response to treatment in NSCLC (large indication) and Her2RMBC (small indication). The validated assays will be deployed in controlled prospective clinical studies and compared with immune-phenotype and molecular data obtained from tumour biopsies and correlated with patient responses to therapy.

Current therapeutic strategies in particular for NSCLC are chemotherapy and drugs targeting specific molecular targets and pathways. The number of specific targets is increasing and about a third of non-squamous cell lung carcinomas especially adenocarcinomas have specific targets. Since these therapeutic targets are only expressed in a subset of tumours the development of companion diagnostics that can be used for stratification and/or monitoring of these therapies in individual patients is of utmost importance for future drug development.

Breast cancer is the most common malignancy in women, and although several therapeutic options are already available (e.g., chemotherapy, endocrine therapy, antibodies, etc.), resistance to these therapies significantly limits the success rates. In CANCER-ID, we will therefore focus on breast cancer patients who failed to respond to HER2-targeted therapies.HER2 is the most prominent molecular target in breast cancer and it defines a clear molecular subtype. Both lung and breast cancer comprise of approx. 800,000 new cases in the EU and these two tumour types are responsible for more than 50% of cancer-related deaths in women.

Blood-based companion diagnostics will be important to improve systemic treatment and to design new clinical trials in these patients. When implemented in clinical practice it will result in personalized medicine by adapting the therapies to the individual risk of the cancer patient. Important challenges for all circulating biomarker developments are assay sensitivity, specificity, standardization and validation. Standard operating procedures (SOPs) are, however, generally lacking and will be provided and introduced by CANCER-ID.

The CANCER-ID partners comprise a unique network of experts in the fields of tumour biology, biomarker development, clinical sciences and bioinformatics. Members of this consortium are all internationally recognized for their work on CTCs, cfDNA and circulating cell free microRNA (cfmiRs), and have implemented liquid biopsies in clinical research studies. In addition, regulatory agencies (EMA/FDA) and patient advocacy group (Mammazone) are involved from the beginning of the project. The coordinators of this consortium have coordinated FP6/FP7 EU consortia and published seminal reports on disseminating tumour cells.