Actively Recruiting
Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-06
31
Participants Needed
2
Research Sites
261 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of HR+ breast cancer with at least 1% hormone receptor expression by immunohistochemistry
- Diagnosis of HER2-negative breast cancer based on ASCO/CAP guidelines
- Having 15 or fewer brain metastases eligible for stereotactic radiation
- Ability to swallow oral medications
- Willingness to comply with all study procedures and availability for the study duration
- Measurable brain disease at least 0.5 cm in size per RANO-BM criteria
- Eligible for stereotactic radiosurgery to brain metastases or post-operative cavities
- Largest intact brain metastasis diameter 4 cm or less
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Availability of tumor tissue sample for biomarker evaluation or willingness to enroll without archival tissue
- Prior stereotactic radiosurgery allowed if active measurable disease has not been treated with radiation
- Women of childbearing potential must have a negative pregnancy test within 7 days before starting abemaciclib
- Women of childbearing potential must agree to contraception during treatment and for 3 weeks after last abemaciclib dose
- Adequate organ function as defined by the study protocol
You will not qualify if you...
- Presence of leptomeningeal disease
- Prior whole brain radiation therapy
- Prior use of abemaciclib for brain metastases or within 6 months for metastatic disease
- Unresolved severe toxicities from prior anticancer therapy except certain neuropathies and mild toxicities
- Pregnancy or breastfeeding
- Serious uncontrolled medical conditions that could interfere with participation
- Active systemic bacterial, fungal, or certain viral infections
- Personal history of certain serious cardiac conditions such as syncope, pathological ventricular arrhythmia, or sudden cardiac arrest
- History of other malignancies within 2 years except low-risk cancers
- Recent major surgery or significant injury less than 14 days before study treatment
- Recent participation in another investigational trial within 2 weeks
- Allergy or hypersensitivity to study drugs or components
- Prisoners or involuntarily incarcerated individuals
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Active, Not Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
K
Kamran A Ahmed, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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