drugset / Trial / NCT07410559
Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer.
Timeline
- Start
- 2026-07-01
- Primary completion
- 2029-04-01
- Completion
- 2031-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 150 mg | Oral |
| Comparator | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Epirubicin | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Imlunestrant | Small molecule | 400 mg | Oral |