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Recruiting Phase 1, Phase 2 NCT04923542

Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases

Trial Parameters

Condition Brain Metastases
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 31
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-11-30
Completion 2026-11-05
Interventions
Stereotactic Radiosurgery (SRS)AbemaciclibEndocrine therapy

Brief 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.

Eligibility Criteria

Inclusion Criteria: * HR+ breast cancer to fulfill the requirement of HR+ disease, a breast cancer must express (≥ 1%), by immunohistochemistry (IHC), at least 1 of the hormone receptors (estrogen receptor \[ER\] or progesterone receptor \[PR\]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines * To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines * ≤ 15 brain metastases eligible for stereotactic radiation * Able to swallow oral medications * Willing to comply with all study procedures and available for duration of the study * Measurable brain disease per RANO-BM criteria that can be measured in at least one dimension as ≥ 0.5 cm for both intact brain metastases and post-operative cavities * Eligible for SRS to brain metastases or to the post-o

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