Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients

This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer. It is a multicenter, prospective clinical study. All enrolled patients will receive either dalpiciclib 125 mg for 2 years or dalpiciclib 100 mg for 3 years, in combination with standard endocrine therapy. The primary endpoint is 3-year invasive disease-free survival (iDFS).

NCT Number	NCT07101159
Lead Sponsor	Fujian Cancer Hospital
Conditions	Early Breast Cancer, Adjuvant Therapy, Hormone Receptor Positive / HER2-negative Breast Cancer
Enrollment	200 participants
Start Date	2025-09
Primary Completion	2031-12 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2025-08-03