Phase IIa Study of Abemaciclib with Endocrine Therapy in Patients 70 Years and Older with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer Who Have Progressed After Prior CDK 46 Inhibitor Treatment

What this Trial Is About

This research aims to evaluate the side effects of abemaciclib monotherapy in patients aged 70 years and older who have hormone receptor positive, HER2 negative metastatic breast cancer that has spread to other parts of the body. The study focuses on estimating the occurrence of severe toxicities grade 3 or higher and describing the full range of side effects, patient-reported adverse events, and treatment adherence. Researchers will also explore the relationship between geriatric assessment scores, aging biomarkers, and toxicity levels. Participants receive abemaciclib orally twice daily in 28-day cycles until disease progression or unacceptable side effects occur. After completing treatment, patients are followed up at 30 days and then every six months for two years. The study includes questionnaires assessing treatment impact and collects blood samples to measure drug concentrations. Throughout the trial, participants undergo regular evaluations including toxicity assessments, dose changes, hospitalizations, and survival outcomes. Researchers will monitor treatment adherence and patient quality of life using specific questionnaires. Follow-up visits continue for two years post-treatment to collect data on long-term effects, disease progression, and survival rates.

Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.