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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.

Phase 1/2RecruitingH. Lee Moffitt Cancer Center and Research InstituteNCT04923542Data as of May 2026

Treatment: Abemaciclib · Endocrine therapyThis 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.

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Extracted 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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