drugset / Trial / NCT04603183
ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, randomized, 2 arm, open label, phase II study. It is designed to compare the efficacy and safety of abemaciclib combined with ET (letrozole or fulvestrant) versus a short course with induction chemotherapy with paclitaxel followed by maintenance therapy with abemaciclib combined with ET (letrozole or fulvestrant) in patients with previously untreated, unresectable locally advanced, or metastatic HR positive/HER2 negative breast cancer with aggressive disease criteria.
Timeline
- Start
- 2021-06-02
- Primary completion
- 2024-06-30
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 150 mg | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 90 mg/m2 | Intravenous |