Article
Author: Schiza, Aglaia ; Lampropoulos, Kostas ; Biganzoli, Laura ; Visani, Luca ; Valachis, Antonis ; Karihtala, Peeter ; Geisler, Jürgen ; Hay, Susanne Dieroff ; Jenset, Marit ; Reales Aviles, José Manuel ; Munoz-Mateu, Montserrat ; Risi, Emanuela ; Meattini, Icro ; Martínez-Ballestero, Iván ; Spathas, Nikolaos ; Kanters, Tim ; Kosmidis, Thanos ; Fotis, Theo ; Markou, Christiana ; Fjermeros, Kamilla ; Nanou, Christina ; Othman, Mukhrizah ; Koutras, Angelos ; Ballesteros, Soledad ; Kosmidis, Paris ; Fricker, Samuel ; Christopoulou, Athina ; Psyrri, Amanda ; Utriainen, Meri ; Mastoraki, Kalliopi ; Santaholma, Marianne ; Linardou, Helena ; de Graaf, Gimon ; Fountzila, Elena ; Lindman, Henrik ; Basdekis, Ioannis ; Rodríguez, Anna Belén ; Gomez-Bravo, Raquel
Current evidence from both randomized trials and real-world studies suggests that older patients with advanced hormone receptor-positive/HER2-negative (HR+/HER2) breast cancer derive clinical benefit from the addition of CDK4/6 inhibitors to endocrine therapy. However, a higher risk for adverse events due to CDK4/6 inhibitors among older patients is evident, leading to a trend of initiating CDK4/6 inhibitors at lower dose in clinical practice, though without evidence. The aim of the IMPORTANT-trial, a pragmatic, multinational, open-label, partly decentralized randomized trial is to investigate whether lower starting dose of CDK4/6 inhibitors combined with endocrine therapy is comparable to full dose in older (≥70 years old) patients with advanced HR+/HER2- breast cancer who are assessed as vulnerable or frail based on comprehensive geriatric assessment.Clinical Trial Registration: NCT06044623 (ClinicalTrials.gov); Registration date: 13 September 2023.