drugset / Trial / NCT04975308
A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.
Timeline
- Start
- 2021-10-04
- Primary completion
- 2024-06-24
- Completion
- 2027-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 150 mg | Oral |
| Subject | Exemestane | Small molecule | 25 mg | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | Imlunestrant | Small molecule | 400 mg | Oral |