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

NCT06650748

Phase 2 Enrolling by invitation 100 enrolled Peking University
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

EvaluationDrugModalityDoseRoute
Subject Dalpiciclib Small molecule 125 g Oral
Subject Letrozole Other / unclassified 2.5 mg Oral

Indications