TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer
Summary
In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. The names of the study drugs involved in this study are: * Abemaciclib (CDK4 and CDK6 inhibitor) * Tamoxifen (Selective estrogen receptor modulator) * Anastrozole/Letrozole (Non-steroidal aromatase inhibitors) * Exemestane (steroidal aromatase inhibitor) * LHRH (Gonadotropin-releasing hormone agonist, or Luteinizing hormone-releasing hormone agonist)
Timeline
- Start
- 2023-10-05
- Primary completion
- 2025-01-22
- Completion
- 2027-01-01
Outcome
Met primary endpoint
registry One-sided binomial test testing whether the reported composite adverse event rate is less than the null hypothesis rate of 40% NCT06001762 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | — | Oral |
| Background | Anastrozole | Other / unclassified | — | Oral |
| Background | Exemestane | Small molecule | — | Oral |
| Background | Letrozole | Other / unclassified | — | Oral |
| Background | Tamoxifen | Small molecule | — | Oral |