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

What this Trial Is About

Breast cancer is a common tumor with a higher occurrence and mortality rate in elderly patients aged 70 years and older. This increased risk is linked to aging-related immune decline, delays in diagnosis, and less aggressive treatment. Elderly patients are underrepresented in clinical trials, and current treatment guidelines are mostly based on studies with younger patients, not fully considering the unique health variations and frailty in older adults. This research aims to better understand how CDK4/6 inhibitors work and how safe they are for older women with breast cancer compared to younger women in real-world settings. This observational study will follow patients with solid tumors who are actively receiving CDK4/6 inhibitors as systemic treatment for breast cancer, including those treated in the adjuvant setting. The study will observe and compare the rates of side effects, therapy switches, and dose reductions between elderly and younger patients. It will also assess invasive disease-free survival over up to 24 months. The study collects data during the treatment period and monitors patients for up to 12 months to evaluate toxicity and treatment outcomes. Participants will be monitored for both hematological and non-hematological side effects during treatment. Researchers will track therapy changes and dose adjustments, and measure disease progression and survival outcomes. The main focus is on safety and treatment response differences between older and younger women with breast cancer. The study is observational, so participants will continue their usual treatment while data are collected. The total follow-up includes up to 24 months for disease-free survival and up to 12 months for toxicity assessments.

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