At a glance
ClinicalIndex Comparison Record- ✓HR+ breast cancer expressing ≥1% ER or PR by IHC
- ✓HER2- disease (no overexpression by IHC or in-situ hybridization)
- ✓≤15 brain metastases eligible for stereotactic radiation
- ✓Able to swallow oral medications
- ✕Presence of leptomeningeal disease
- ✕Prior whole brain radiation therapy
- ✕Prior abemaciclib in brain metastases setting or within past 6 months for metastatic disease
- ✕Unresolved toxicities from prior anticancer therapy (except specified exceptions) exceeding Grade 1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases
In Brief
A Phase 2 clinical trial evaluating Stereotactic Radiosurgery (SRS), Abemaciclib, and 1 other intervention for Brain Metastases and HR+ Metastatic Breast Cancer. Currently recruiting, targeting 31 participants across 2 sites.
Detailed Summary
This is a single arm study of abemaciclib and endocrine therapy with stereotactic radiosurgery (SRS) among patients with hormone receptor (HR)+/HER2- metastatic breast cancer brain metastases.
Study Details
Timeline
Interventions
Patients will receive single session SRS to intact brain metastases and post-operative cavities. For intact brain metastases, this will be 15 Gy to lesions between 31-40 mm, 18 Gy to 21- 30 mm, and 24 Gy to lesions measuring ≤ 20 mm.
Abemaciclib is an orally administered selective small-molecule inhibitor of CDK4 and CDK6 that is 14 times more potent against CDK4 than CDK6 in enzymatic assays that is approved for the treatment of advanced or metastatic breast cancers. Abemaciclib will be administered at a dose of 150 mg twice daily.
Abemaciclib will be administered with standard of care endocrine therapy. Endocrine therapy can consist of fulvestrant or an aromatase inhibitor. Dosing of concurrent endocrine therapy with abemaciclib should follow standard dosing and safety guidelines.