drugset / Trial / NCT06650748
Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, single-center, randomize-controlled study. The purpose of this study is to evaluate the efficacy of neoadjuvant CDK4/6 inhibitors in patients with high-risk EPclin multigene risk analysis and non-response to Ki-67 2W, and to explore predictive biomarkers for sensitivity to CDK4/6 inhibitor therapy.
Timeline
- Start
- 2025-05-01
- Primary completion
- 2027-10-01
- Completion
- 2028-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalpiciclib | Small molecule | 125 g | Oral |
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |