Project description
Advancing precision medicine in HER2-positive breast cancer with HER2DX
Building on significant advances in HER2-positive breast cancer treatment, many patients can now benefit from less intensive therapeutic approaches. The EU-funded DEFINITIVE project seeks to validate the clinical utility of HER2DX, a novel 27-gene test designed to personalise therapy for early-stage HER2-positive breast cancer. As a minimally invasive tool, HER2DX has the potential to reduce treatment-related toxicities, enhance quality of life, and optimise healthcare costs, all while maintaining efficacy and survival outcomes. DEFINITIVE brings together a multidisciplinary consortium of international experts, including leading hospitals, cancer research networks, and specialists in regulatory affairs and medical statistics. By generating robust clinical evidence, the project aims to support the integration of HER2DX into clinical guidelines, fostering the adoption of affordable, genomics-driven precision oncology in routine practice.
Objective
HER2+ breast cancer affects around 390.000 women annually worldwide (i.e. 3 patients every 4 minutes). Over the last decade, polychemotherapy and HER2-targeted therapies have improved patients survival; however, the reality is that most patients are cured with less intense, toxic, and costly drugs. Up to now, no diagnostic test existed to guide the optimal therapy for each patient. The 27-gene HER2DX test (TRL8) is a novel minimally invasive diagnostic tool which provides unprecedented predictive information for therapy optimization in early-stage HER2+ disease. The DEFINITIVE project will prospectively validate HER2DX`s clinical effectiveness, proving its ability to significantly i) reduce toxicities, ii) improve quality of life and ii) reduce direct and indirect costs, while maintaining efficacy endpoints and survival outcomes in patients with early HER2+ breast cancer.
DEFINITIVE will combine international experts in breast cancer from international reference hospitals, comprehensive cancer networks, regulatory, HTA and medical statistics experts, SMEs, policy makers, patient associations, living labs and medical society networks. DEFINITIVE consortium will conduct a pragmatic clinical trial across 44 centres in 7 European and associated countries to randomize 304 patients with stage II to IIIA HER2+ breast cancer, in a 1:1 manner, and to be treated with the result of the HER2DX test to guide treatment vs without the result of the test (treatment by physicians choice according to local guidelines). The inclusion and exclusion criteria will be very broad to make sure that most patients can participate in the trial and the results could be generalized to the overall population treated in real-world settings. Beyond seeking the endorsement and implementation of HER2DX diagnostic test by clinical guidelines and healthcare systems, DEFINITIVE will boost the incorporation of affordable non-invasive diagnostic tools in the field of genomics and precision oncology.
This action is part of the Cancer Mission cluster of projects on Diagnostics and Treatment (diagnostics).
Fields of science (EuroSciVoc)
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Keywords
Programme(s)
- HORIZON.2.1 - Health Main Programme
Topic(s)
Funding Scheme
HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinator
08036 Barcelona
Spain