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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 9different countries, assuring European coverage and contribution throughmultidisciplinary expertise to the project’s main objectives.
DEFINITIVE also seeks to prove that HER2DX® is safe and efficient, and will reduce direct and indirect costs for hospitals and public health systems.
Project Number 101136953
HER2DX®, developed by REVEAL GENOMICS®, is the first minimally invasive diagnostic assay based on artificial intelligence to optimize HER2-positive breast cancer treatment, improving patients' quality of life without compromising its results.
To do so, the genomic tool analyzes 27 genes involved in 4 key biological processes that lead to tumor development and combines this information with two clinically used parameters: tumor size and the involvement of lymph nodes. This information is integrated into an artificial intelligence algorithm that provides scores to predict the potential evolution of the disease and guide medical doctors in choosing the optimum treatment.
This tool has already been validated in over 2,000 patients.
HER2-positive breast cancer tumors are clinically and biologically heterogeneous; they show differences among patients.
This heterogeneity means that not all patients respond the same way to the treatment, so there is a window to refine the treatment in every clinical case, either by shortening or reinforcing it.
All these tumors share a common surname, HER2+, but a specific name is required to assess them individually. The HER2DX® genomic tool analyzes biological and clinical information from the tumor to precisely identify each of them. It provides medical doctors with information to select the optimal treatment for each patient.
The DEFINITIVE assay is a 5-year international phase III clinical trial conducted over 44 centers in 7 European and associated countries. DEFINITIVE is a two-arm randomized trial; this means that 304 patients with early-stage (stage II to IIIA) HER2-positive breast cancer who have not received previous treatment will be randomly divided into two groups to compare the outcomes:
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. We will determine the response rate to the neoadjuvant therapy during the surgery in both groups. We 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. We 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. We 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.
The DEFINITIVE study will be a collaborative effort involving 18 esteemed entities from across the healthcare and research spectrum. This includes leading hospitals, research groups, universities, and cancer care organizations.
The DEFINITIVE study will be a collaborative effort involving 18 esteemed entities from across the healthcare and research spectrum. This includes leading hospitals, research groups, universities, and cancer care organizations.
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.
