drugset / Trial / NCT05386108
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.
Timeline
- Start
- 2022-08-31
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 100 mg | — |
| Subject | Abemaciclib | Small molecule | 150 mg | — |
| Subject | Elacestrant | Other / unclassified | 300 mg | — |
| Subject | Elacestrant | Other / unclassified | 400 mg | — |