2023-2028 DEFINITIVE project
BACKGROUND
The DEFINITIVE project is a clinical trial funded by the European Commission that aims to demonstrate that making personalized treatment decisions in early-stage HER2-positive breast cancer using HER2DX® diagnostic assay improves the quality of life without affecting the outcome and survival rates.
The DEFINITIVE project is a clinical trial funded by the European Commission that aims to demonstrate that making personalized treatment decisions in early-stage HER2-positive breast cancer using HER2DX® diagnostic assay improves the quality of life without affecting the outcome and survival rates.
DEFINITIVE consortium is composed of 18 partners from 7 different countries, assuring European coverage and contribution throughmultidisciplinary expertise to the project’s main objectives.
The project also seeks to prove that HER2DX® is safe and efficient, and will reduce direct and indirect costs for hospitals and public health systems.
ACKNOWLEDGMENTS
Horizon Europe Grant Agreement No. 101136953. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HADEA. Neither the European Union nor the granting authority can be held responsible for them.
GOALS
Besides demonstrating the improvement in the quality of life of patients following HERD2X®-guided treatment, the DEFINITIVE project has clear objectives to illustrate the value of HERD2X® in daily clinical practice:
- To evaluate whether the strategy of tailoring treatment by HER2DX presents similar efficacy outcomes to that recommended by a physician following local guidelines. The study group will determine the response rate to the neoadjuvant therapy during the surgery in both groups. They will also assess other parameters related to the recurrence of the disease or metastasis presence.
- To evaluate other health-related quality of life outcomes (functional and symptom values), using the same questionnaire.
- To evaluate the safety and tolerability of test-guided treatment and their corresponding standard treatment. The study group will analyze the incidence, duration, and severity of adverse effects.
- To evaluate the physicians’ confidence in the final therapeutic decision in patients treated with the test compared to those treated without the test.
- To analyze the financial impact of the HER2DX test in direct costs for hospitals and public healthsystems and indirect costs for public systems. The study group will compare thecost-effectiveness in patients with and without HER2DX test information.
- To evaluate the impact on work productivity of potential de-escalation of treatment, reducing the intensity or aggressiveness, following tailored treatment by HER2DX.
ACKNOWLEDGMENTS
Horizon Europe Grant Agreement No. 101136953. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HADEA. Neither the European Union nor the granting authority can be held responsible for them.
This work has received funding from the Swiss State Secretariat for Education, Research and Innovation (SERI).
Webinar
23.09.2025 18:00 CEST
Matti Aapro, Paola Clauser, Elisabetta Munzone
