Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)
Status:
Recruiting
Trial end date:
2026-06-30
Target enrollment:
Participant gender:
Summary
CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with
HR+ tumors. However, there is no established standard treatment for patients who experience
treatment failure with CDK4/6 inhibitors. The MAINTAIN study has shown clinical benefits by
switching to Ribociclib and changing endocrine therapy after progression on CDK4/6
inhibitors. We hypothesize that combining Dalpiciclib with physician-selected endocrine
therapy, following treatment failure with CDK4/6 inhibitors, would similarly lead to improved
patient survival. In this study, 18F-FES PET/CT will be employed as a non-invasive
alternative to biopsy techniques for evaluating the expression of ER in various systemic
lesions of the patients.