CDK4/6 Inhibitors in Breast Cancer Elderly Patients: an Observational Ambispective Longitudinal Multicenter Study

Breast cancer is one of the tumors with the highest incidence and current evidence indicates a higher prevalence in elderly patients (≥70 years) with a higher mortality rate due to immunosenescence, diagnostic delay and under treatment. Elderly patients are still poorly represented in clinical trials and the main indications for the treatment of the elderly population are extrapolated from the guidelines used in studies conducted predominantly on the younger population. In particular, these guidelines do not take into account the significant variability of elderly patients, in particular their comorbidities, performance status, physiological age and frailty. The aim of this study is to improve understanding of the clinical efficacy and safety of CDK 4/6i in older women in a real-world setting compared to younger women.

NCT Number	NCT07399808
Lead Sponsor	Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions	Breast Cancer, Old Age
Enrollment	100 participants
Start Date	2025-03-21
Primary Completion	2026-03 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-02-10