drugset / Trial / NCT07101159
Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients
Non-randomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2025-09
- Primary completion
- 2031-12
- Completion
- 2031-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalpiciclib | Small molecule | 100 mg | Oral |
| Subject | Dalpiciclib | Small molecule | 125 mg | Oral |
| Background | Anastrozole | Other / unclassified | — | — |
| Background | Exemestane | Small molecule | — | — |
| Background | Letrozole | Other / unclassified | — | — |
| Background | Tamoxifen | Small molecule | — | — |