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

Conditions studied

Breast Cancer, Old Age

About this 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.

Primary outcomes

• Evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during administration of CDK 4/6i. (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)

Eligibility information

Study locations

• Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia, Pavia 27100 Italy