Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients
Status:
NOT_YET_RECRUITING
Trial end date:
2031-12-01
Target enrollment:
Participant gender:
Summary
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).