📋 Tender Overview
Implementing Geriatric Assessment For Dose Optimization Of Cdk 4/6-Inhibitors In Older Breast Cancer Patients
Current Evidence From Both Randomized Trials And Real-World Evidence Studies Suggests That Older Breast Cancer Patients Derive Clinical Benefit From The Addition Of Cdk 4/6-Inhibitors To Endocrine Therapy But With Higher Risk For Adverse Events And Treatment Discontinuation Compared To Younger Patients. The Important Project Will Design And Conduct A Pragmatic Clinical Study 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. This Study Will Be Conducted Across 6 (Six) Eu Countries, And Will Include More Than 500 Female And Male Patients. The Project Will Also Perform A Series Of Analyses Over A) A Wide Range Of Clinical-Relevant Primary And Secondary Endpoints Targeting To Contribute To Current Clinical Practice And B) The Implementation Of Specific Strategies Aiming At More Individualized Treatment And Follow-Up Approaches To A Clinical Trial Setting That Highly Resembles Real-World Setting Due To The Trial~S Pragmatic Design.
The Project Will Be Developed In 60 Months By A Competitive Consortium Of 19 Partners From 11 Countries, Which Corresponds To A Well-Balanced Structure, Involving Clinical Sites, Smes, Universities And Patient Advocacy Organizations. Despite The Great Diversity Of Entities Within The Proposal, Important Partners Bring State-Of-The-Art Complementary Skills Ensuring The Ability Of The Consortium To Successfully Complete The Proposed Work.This Action Is Part Of The Cancer Mission Cluster Of Projects On ‘Diagnosis And Treatment’.
Funded Under
Health
Total Cost
€ 5 415 012,50
Eu Contribution
€ 5 415 012,50
Coordinated By
Orebro Lans Landsting
Sweden
Start Date
1 May 2023
End Date
30 April 2028
Objective
Current evidence from both randomized trials and real-world evidence studies suggests that older breast cancer patients derive clinical benefit from the addition of CDK 4/6-inhibitors to endocrine therapy but with higher risk for adverse events and treatment discontinuation compared to younger patients. The IMPORTANT project will design and conduct a pragmatic clinical study 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. This study will be conducted across 6 (six) EU countries, and will include more than 500 female and male patients. The project will also perform a series of analyses over a) a wide range of clinical-relevant primary and secondary endpoints targeting to contribute to current clinical practice and b) the implementation of specific strategies aiming at more individualized treatment and follow-up approaches to a clinical trial setting that highly resembles real-world setting due to the trial's
