drugset / Trial / NCT07213206
CDK4/6 Inhibitor Intensification and Chemotherapy De-Escalation for Early-stage Luminal-HER2 Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The investigators designed a phase III clinical trial involving hormone receptor-positive and HER2-positive stage I breast cancer patients. This trial aims to evaluate the efficacy and safety of a treatment regimen combining CDK4/6 inhibitors, endocrine therapy, and anti-HER2 therapy compared with the traditional approach of chemotherapy combined with anti-HER2 therapy.
Timeline
- Start
- 2025-10-07
- Primary completion
- 2032-09-01
- Completion
- 2035-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | — | — |
| Comparator | Docetaxel | Small molecule | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |
| Comparator | Tamoxifen | Small molecule | — | — |
| Background | Trastuzumab | Monoclonal antibody | — | — |