Study Evaluating Geriatric Screening and Adjuvant CDK46 Inhibitor Treatment in Breast Cancer Patients Aged 70 and Older

What this Trial Is About

Researchers are investigating the use of adjuvant CDK46 inhibitors combined with endocrine therapy in older breast cancer patients aged 70 years and above. This study focuses on the specific challenges faced by this population, including comorbidities that may increase the risk of treatment-related toxicities and affect quality of life. Due to limited representation of older patients in previous trials, this study aims to better understand the benefits and risks of such treatment in this age group and the role of geriatric assessments to guide therapy. Participants will undergo geriatric screening using tools such as the Geriatric 8 G8 and Vulnerable Elders Survey-13 VES-13 to assess frailty before starting adjuvant CDK46 inhibitor therapy alongside endocrine treatment. The study will examine multiple outcomes including treatment side effects, dose intensity, treatment discontinuation, quality of life, hospitalization, cancer recurrence, and survival. These measures will be collected over several years with follow-ups at various intervals, up to 10 years for some outcomes. Throughout the study, participants will complete questionnaires assessing frailty and quality of life at baseline and at multiple points after starting treatment. Adverse events, hospitalizations, dose adjustments, and treatment discontinuation will be monitored regularly up to six months after ending CDK46 inhibitor therapy. Long-term outcomes such as breast cancer recurrence and survival will be tracked at 3, 5, and 10 years. This approach aims to provide a thorough evaluation of how geriatric screening relates to treatment effects and long-term health in this patient group.

Aspects of Adjuvant CDK4/6 Inhibitors in Older Breast Cancer Patients - Focusing on Geriatric Screening