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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

November 30, 2021

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Brain MetastasesHR+ Metastatic Breast Cancer
Interventions
RADIATION

Stereotactic 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.

DRUG

Abemaciclib

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.

DRUG

Endocrine 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.

Trial Locations (2)

33612

RECRUITING

Moffitt Cancer Center, Tampa

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER