Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer

This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant culmerciclib in combination with aromatase inhibitors in patients with highly proliferative ER-positive/HER2-negative breast cancer. All patients initially receive induction treatment with culmerciclib plus endocrine therapy, followed by on-treatment assessment of biological and clinical response. Patients demonstrating an adequate response continue the same regimen, whereas those with a suboptimal response are transitioned to alternative treatment strategies prior to surgery. This adaptive approach aims to optimize treatment selection, improve therapeutic efficacy, and avoid unnecessary exposure to ineffective therapy.

NCT Number	NCT07616453
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	HR+/HER2- Early Breast Cancer
Enrollment	45 participants
Start Date	2026-05-06
Primary Completion	2028-05-05 (estimated)
Study Completion	2033-05-05 (estimated)
Updated on ClinicalTrials.gov	2026-06-01