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

目前来自随机试验和现实世界证据研究的证据表明，老年乳腺癌患者从在内分泌治疗中添加cdk4 /6抑制剂中获得临床获益，但与年轻患者相比，不良事件和停药的风险更高。该重要项目将设计并开展一项实用的临床研究，采用分散式方法对老年晚期乳腺癌患者进行研究，以研究较低初始剂量的cdk4 /6抑制剂与全剂量对易感/虚弱患者的疗效。来自重要项目的结果将产生具有多层结果的高水平证据（I级），可以改变当前的临床实践。这项研究将在6个欧盟国家进行，将包括500多名女性和男性患者。该项目还将对以下方面进行一系列分析：a)广泛的临床相关主要和次要终点，目标是为当前的临床实践做出贡献；b)实施具体策略，旨在实现更个性化的治疗和后续方法，使临床试验环境与现实世界环境高度相似，因为试验的实用设计。该项目将在60个月内由来自11个国家的19个合作伙伴组成的竞争性联盟开发，这符合一个均衡的结构，涉及临床站点、中小企业、大学和患者倡导组织。尽管提案中的实体非常多样化，但重要的合作伙伴带来了最先进的互补技能，确保了财团成功完成拟议工作的能力。这一行动是癌症使命“诊断和治疗”项目集群的一部分。

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 investigating the efficacy of lower initial dose of CDK 4/6-inhibitors compared to full dose for vulnerable/frail patients. The results derived from the IMPORTANT project will produce 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’.