Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 Inhibitor

This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node negative disease receiving adjuvant endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.

NCT Number	NCT06996093
Lead Sponsor	Fudan University
Conditions	Breast Cancer
Enrollment	2,508 participants
Start Date	2025-06-02
Primary Completion	2030-06-01 (estimated)
Study Completion	2034-06-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-30