Geriatric Assessment to Optimize CDK 46-inhibitor Doses for Older Patients with Advanced HR-positive, HER2-negative Breast Cancer A Pragmatic Phase 3 Randomized Trial

What this Trial Is About

Researchers are studying older patients aged 70 years and above with advanced hormone receptor-positive and HER2-negative breast cancer that cannot be cured and who have not received prior therapy for advanced disease. This trial aims to evaluate the use of comprehensive geriatric assessment CGA to guide dosing decisions for CDK 46-inhibitors combined with endocrine therapy as first-line treatment. The goal is to determine whether adjusting doses based on patients vulnerability can help improve treatment tolerance without reducing effectiveness. Participants classified as fit by CGA will receive a full dose of one of the CDK 46-inhibitors Palbociclib, Ribociclib, or Abemaciclib plus endocrine therapy chosen by their physician. Those identified as vulnerable or frail will be randomly assigned to receive either a full dose or a reduced initial dose of the CDK 46-inhibitor, alongside endocrine therapy. Dosage schedules involve a 21-day treatment period followed by 7 days off, with specific dosing amounts depending on the drug used. During the study, participants will be monitored for up to five years to assess time to treatment failure, overall survival, progression-free survival, and the time until chemotherapy is needed. Quality of life and adverse events will be evaluated up to 24 months or until disease progression or other endpoints occur. Researchers will also assess overall treatment utility and cost effectiveness. The study includes ongoing safety monitoring and requires informed consent and adequate organ function for participation.

Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients