The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.
Aged ≥18 years at signing of informed consent.
Both male and female patients are allowed
Histologically confirmed metastatic breast cancer (mBC), current stage IV.
Plan for ablative radiotherapy (SBRT) to a bone metastasis.
Treatment to bone lesions in the calvarium are not eligible for the dose-finding or expansion portions of the study. Patients who otherwise have calvarial lesions not undergoing treatment on this protocol are eligible to enroll.
Patients currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to the start of study intervention, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.
Patients who received radiation therapy ≤14 days prior to initiation of investigational agents are excluded.
Single group
Abemaciclib
DrugThe dose escalation portion of the study, a 3+3 design will be used. Once the MTD of Abemaciclib is reached, the phase Ib expansion portion will enroll up to 10 additional patients also requiring palliation to bone metastases
Radiation Therapy
Radiation27Gy in 3 daily fractions or 30Gy in 5 daily fractions completed entirely within 28 days of simulation via stereotactic body radiotherapy (SBRT).
Maximum tolerated dose/MTD of abemaciclib
The primary endpoint of the study is defining the MTD of abemaciclib in combination with Radiation Therapy/RT
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Eli Lilly and Company
Collaborator
