drugset / Trial / NCT07005557
Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged \>65 years) with lymph node-positive, HR+/HER2- breast cancer.
Timeline
- Start
- 2025-06-15
- Primary completion
- 2030-05-15
- Completion
- 2035-05-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | — | — |
| Subject | Anastrozole | Other / unclassified | — | — |
| Comparator | Capecitabine | Small molecule | — | — |
| Subject | Dalpiciclib | Small molecule | — | — |
| Subject | Exemestane | Small molecule | — | — |
| Subject | Letrozole | Other / unclassified | — | — |
| Subject | Palbociclib | Small molecule | — | — |
| Subject | Ribociclib | Small molecule | — | — |