NCT07101159

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

Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy in Early-stage HR-positive/HER2-negative Breast Cancer: a Multicenter, Prospective Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Early Breast Cancer
• Adjuvant Therapy
• Hormone Receptor Positive / HER2-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Dalpiciclib	Dalpiciclib 100 mg orally, daily on days 1-21 of a 28-day cycle, for 3 years.
DRUG	Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)	Standard adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitor), as per physician's choice.
DRUG	Dalpiciclib	Dalpiciclib 125 mg orally, daily on days 1-21 of a 28-day cycle, for 2 years.

Timeline

• Start date: 2025-09-01
• Primary completion: 2031-12-01
• Completion: 2031-12-01
• First posted: 2025-08-03
• Last updated: 2025-08-03