IMPLEMENTING GERIATRIC ASSESSMENT FOR DOSE OPTIMIZATION OF CDK 4/6-INHIBITORS IN OLDER BREASTCANCER PATIENTS
Challenge
The addition of CDK 4/6-inhibitors to endocrine therapy as a first or a second line treatment in patients with advanced hormone receptor-positive (HR+)/HER2-negative breast cancer, has shown to improve survival in all patient subgroups, including older patients . Despite the advances in the treatment of HR+/HER2-negative breast cancer, the five-year overall survival is approximately 40% according to real-world evidence, thus classifying this disease as refractory in terms of overall survival. Moreover, no randomized evidence exists on initiating with a lower dose of CDK 4/6-inhibitors for patients with advanced HR+/HER2-negative breast cancer and there is a paucity of evidence on how to overcome the underrepresentation of older cancer patients in clinical trials. Additional relevant outcomes and metrics have been recognised as essential for an unbiased and reliable assessment of the clinical utility of a treatment strategy and should be ideally adopted in clinical trials along with cancer-specific endpoints. Even though technological tools can provide innovative solutions, the healthcare sector needs time to incorporate them inside the existing practices and operations.
The vision of the IMPORTANT project is to design and conduct a pragmatic clinical study, with a decentralised approach, for older patients (both male and female) with refractory1 advanced HR+/HER2- negative breast cancer, aiming at high level of evidence (level I) with multi-layer results that can enable changes in current clinical practice.
Objectives
Design and conduct a pragmatic clinical study across six EU countries with a decentralised approach for older patients with advanced breast cancer aiming at high level of evidence (level I) with multi- layer results that can enable changes in current clinical practice.
Focus on the issues of including older breast cancer patients in clinical studies and create innovative solutions and guidelines to address the underrepresentation problem of older patients in clinical trials in general.
Analyse the clinical study outcomes as sources for developing high quality evidence and identify study-related indirect results that can improve multiple aspects in overall cancer care.
Engaging the healthcare community through information collected during the study design and execution phase as well as contributing project’s results and lessons learned.
Explore scientific and technical innovation and create services and solutions that can directly benefit cancer treatment and care the healthcare sector in general
Our Role
In this project, Eunomia Ltd will be responsible for all the legal and ethical aspects regarding the design and implementation of the study, as well as monitoring the data management, any IPR issues, and EU healthcare regulatory and policies.