IMPORTANT Project

IMPlementing geriatric assessment for dose Optimization of CDK 4/6-inhibitors in older bReasT cAncer patieNTs

The Vision

To design and conduct a pragmatic clinical study with a decentralised approach for older patients (both male and female) with refractory 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.

Specifically, IMPORTANT study is a multi-centre, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach. The study aims to investigate the prognosis, tolerability, and quality of life of vulnerable or frail older breast cancer patients treated with lower initial dose of CDK 4/6-inhibitors plus endocrine therapy compared to the recommended full dose of CDK 4/6-inhibitors.

Comprehensive geriatric assessment will be applied as the basis for the assessment of patients' frailty before randomization.

Innovations

The individualized shared decision-making approach for dose optimization by tailoring the initial dose of CDK 4/6-inhibitors based on the frailty status of each patient.

The optimized clinical trial recruitment methodology designed to help a) older patients and b) less tech-savvy users in general, to join a healthcare ecosystem that is transitioning toward digital tools and services.

The overall healthcare costs and a financial model to optimize resource utilization for the Healthcare System financial burden, older-patient financial toxicity, and older-patient side-effect toxicity.

The preparation of a Geriatric cancer registry based on the combination of data inputs collected from the continuous geriatric assessment as well as the quality of life validated questionnaires.

Identified Challenges

No randomized evidence exists on initiating with a lower dose of CDK 4/6-inhibitors for patients with advanced HR+/HER2-negative breast cancer

Cancer care usually focuses on specific aspects of the problem and not the continuum of care, providing solutions on different timescales and focus areas.

There is a paucity of evidence on how to overcome the under-representation of older cancer patients in clinical trials.

Even though technological tools can provide innovative solutions, the healthcare sector needs time to incorporate them inside the existing practices and operations.

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.