drugset / Trial / NCT06585969
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative metastatic breast cancer
Timeline
- Start
- 2026-01-01
- Primary completion
- 2026-01-01
- Completion
- 2026-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abemaciclib | Small molecule | 125 mg | — |
| Comparator | Abemaciclib | Small molecule | 150 mg | — |
| Comparator | Anastrozole | Other / unclassified | 1 mg | — |
| Comparator | Exemestane | Small molecule | 25 mg | — |
| Comparator | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Comparator | Letrozole | Other / unclassified | 2.5 mg | — |
| Comparator | Ribociclib | Small molecule | 600 mg | — |
| Comparator | Tamoxifen | Small molecule | 20 mg | — |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |