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

对老年乳腺癌患者实施老年评估以优化 CDK 4/6 抑制剂的剂量

• 批准号: 10072029
• 金额: $ 61.38万
• 依托单位: CARE ACROSS LTD
• 依托单位国家: 英国
• 项目类别: EU-Funded
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10072029
• 关键词: IMPlementing; geriatric; assessment; dose; Optimization

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’.

目前来自随机试验和真实世界证据研究的证据表明，老年乳腺癌患者从内分泌治疗中添加CDK 4/6抑制剂中获得临床获益，但与年轻患者相比，不良事件和治疗中止的风险更高。IMPORTANT项目将设计和开展一项实用的临床研究，采用分散的方法，针对老年晚期乳腺癌患者，研究较低初始剂量的CDK 4/6抑制剂与全剂量相比，对脆弱/虚弱患者的疗效。来自IMPORTANT项目的结果将产生高水平的证据（I级），具有多层结果，可以改变当前的临床实践。本研究将在6个欧盟国家进行，将纳入500多名女性和男性患者。该项目还将对以下内容进行一系列分析：a）广泛的临床相关主要和次要终点，旨在促进当前的临床实践; B）实施特定策略，旨在为临床试验环境提供更个性化的治疗和随访方法，由于试验的务实设计，临床试验环境与真实世界环境非常相似。该项目将由来自11个国家的19个合作伙伴组成的竞争性财团在60个月内开发，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。尽管提案中的实体多种多样，但重要的合作伙伴带来了最先进的补充技能，确保联合体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”项目组的一部分。