RecruitingPhase 1Phase 2NCT04923542

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

Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

31 participants

Start Date

Nov 30, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing abemaciclib (a targeted oral therapy that blocks cancer cell division) combined with stereotactic radiosurgery (a very precise, focused form of radiation) for women with hormone receptor-positive, HER2-negative breast cancer that has spread to the brain. **You may be eligible if:** - You have HR+/HER2- breast cancer with up to 15 brain tumors eligible for stereotactic radiosurgery - Your tumors are small enough (largest is 4 cm or less) for focused radiation - You can swallow oral medications - Your overall health is good (ECOG 0–2) - You have measurable brain disease on imaging **You may NOT be eligible if:** - Your brain tumors are too large or too numerous for stereotactic radiosurgery - You are unable to take oral medications - You have significant other health conditions that would make the study unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Radiosurgery (SRS)

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.

DRUGAbemaciclib

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.

DRUGEndocrine therapy

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.


Locations(2)

Moffitt Cancer Center

Tampa, Florida, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT04923542


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