drugset / Trial / NCT04293393
Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients
Phase 2
Active not recruiting
200 enrolled
Spanish Breast Cancer Research Group
Eli Lilly and Company · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Phase II, randomized, open-label, international, multicenter study to compare efficacy of standard chemotherapy vs. letrozole plus abemaciclib as neoadjuvant therapy in HR-positive/HER2-negative high/intermediate risk breast cancer patients
Timeline
- Start
- 2020-10-02
- Primary completion
- 2023-06-21
- Completion
- 2033-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 150 mg | Oral |
| Comparator | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Comparator | Docetaxel | Small molecule | 100 mg/m2 | — |
| Comparator | Doxorubicin | Other / unclassified | 60 mg/m2 | — |
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Background | Goserelin | Other / unclassified | — | — |
| Background | Leuprolide | Other / unclassified | — | — |