ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer

This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus ET in patients with circulating tumor DNA (ctDNA)-negative, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

NCT Number	NCT07423611
Lead Sponsor	Fudan University
Conditions	Breast Cancer
Enrollment	388 participants
Start Date	2026-10-01
Primary Completion	2030-10-01 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-20