At a glance
ClinicalIndex Comparison Record- ✓Women or men aged ≥18 years at informed consent
- ✓ER-positive, HER-2 negative tumor status confirmed by local testing
- ✓Phase 2: at least one active and measurable brain metastasis per RECIST 1.1
- ✓Phase 1b: presence of brain metastases allowed but not required; at least 1 measurable lesion outside brain required
- ✕Immediate CNS-specific treatment likely required per treating physician assessment
- ✕Imminent organ failure and/or visceral crisis
- ✕Leptomeningeal metastases with positive CSF cytology or unequivocal radiologic/clinical evidence
- ✕Breast cancer treatment-naïve in advanced/metastatic setting
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Elacestrant and Abemaciclib for Breast Neoplasms and 7 related conditions. Currently recruiting, targeting 73 participants across 86 sites in 10 countries.
Detailed 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.
Study Details
Timeline
Interventions
300 mg, 400 mg
100 mg, 150 mg