drugset / Trial / NCT07019363
CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated greater clinical benefits for advanced TPBC patients. This study aims to investigate the efficacy and safety of CDK4/6 inhibitor combination with standard adjuvant endocrine therapy in HR+/HER2+ early breast cancer patients.
Timeline
- Start
- 2025-06-15
- Primary completion
- 2029-05-15
- Completion
- 2033-04-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anastrozole | Other / unclassified | — | — |
| Comparator | Exemestane | Small molecule | — | — |
| Comparator | Letrozole | Other / unclassified | — | — |
| Comparator | Tamoxifen | Small molecule | — | — |