Trials / Recruiting
RecruitingNCT05386108
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 73 (estimated)
- Sponsor
- Stemline Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Breast Neoplasms
- Brain Neoplasms
- Neoplasms by Site
- Neoplasms
- Breast Diseases
- Central Nervous System Neoplasms
- Brain Diseases
- Central Nervous System Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elacestrant | 300 mg, 400 mg |
| DRUG | Abemaciclib | 100 mg, 150 mg |
Timeline
- Start date
- 2022-08-31
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2022-05-23
- Last updated
- 2026-04-06
Locations
86 sites across 10 countries: United States, Belgium, France, Germany, Greece, Italy, South Korea, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05386108. Inclusion in this directory is not an endorsement.