drugset / Trial / NCT04031885
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to internal organs. Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.
Timeline
- Start
- 2019-08-14
- Primary completion
- 2020-08-11
- Completion
- 2020-08-11
Outcome
Outcome not reported
Stopped (Enrollment): “Business decision based on the inability to enroll subjects into the trial”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 150 mg | Oral |
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Docetaxel | Small molecule | — | — |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | Nab-paclitaxel | Small molecule | — | — |
| Subject | Paclitaxel | Small molecule | — | — |