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

来自随机试验和真实世界证据研究的最新证据表明，与年轻患者相比，老年乳腺癌患者从内分泌治疗中添加CDK4/6抑制剂获得临床好处，但发生不良事件和停止治疗的风险更高。这一重要项目将为老年晚期乳腺癌患者设计和实施一项实用的临床研究，采用分散的方法，调查较低初始剂量的CDK 4/6-抑制剂对脆弱/虚弱患者的疗效。这个重要项目的结果将产生高水平的证据(I级)，具有多层次的结果，可以使当前的临床实践发生变化。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a)广泛的与临床相关的主要和次要终点进行一系列分析，以促进当前的临床实践，以及b)实施旨在更个人化治疗的特定战略和后续方法，以实现与现实世界非常相似的临床试验环境(由于试验的务实设计)。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财团开发，这相当于一个平衡的结构，涉及临床站点、中小企业、大学和患者倡导组织。尽管提案中的实体千差万别，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。这项行动是癌症使命“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’.