DEFINITIVE
Financiado
Diagnostic HER2DX-guided treatment for patients with early-stage HER2-positive b...
Diagnostic HER2DX-guided treatment for patients with early-stage HER2-positive breast cancer
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 patient´s survival; however, the reality is th...
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 patient´s 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 physician´s 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).
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Duración del proyecto: 59 meses
Fecha Inicio: 2023-12-11
Fecha Fin: 2028-11-30
Fecha Fin: 2028-11-30
Línea de financiación: concedida
El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2023-12-11
Línea de financiación objetivo
El proyecto se financió a través de la siguiente ayuda:
Presupuesto
El presupuesto total del proyecto asciende a
8M€
Líder del proyecto
FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA
No se ha especificado una descripción o un objeto social para esta compañía.
Perfil tecnológico
TRL
4-5
650K
Perfil tecnológico
TRL
4-5
650K
139.62K€ |
Participante
206.25K€ |
Participante
812.00K€ |
Participante