OncoMatch/Clinical Trials/NCT04923542
Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases
Is NCT04923542 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Abemaciclib and Endocrine therapy for brain metastases.
Treatment: Abemaciclib · Endocrine therapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression ≥ 1% (≥ 1% by IHC)
a breast cancer must express (≥ 1%), by immunohistochemistry (IHC), at least 1 of the hormone receptors (estrogen receptor [ER] or progesterone receptor [PR])
Required: PR (PGR) expression ≥ 1% (≥ 1% by IHC)
a breast cancer must express (≥ 1%), by immunohistochemistry (IHC), at least 1 of the hormone receptors (estrogen receptor [ER] or progesterone receptor [PR])
Required: HER2 (ERBB2) wild-type (no overexpression by IHC or in-situ hybridization)
a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: whole brain radiation therapy
Prior receipt of whole brain radiation therapy
Cannot have received: CDK4/6 inhibitor (abemaciclib)
Exception: allowed if not in the setting of brain metastases and not within past 6 months for metastatic disease
Prior receipt of abemaciclib in the setting of brain metastases or in the past 6 months for the treatment of metastatic disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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