A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer
Summary
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.
Arms & interventions
- DrugAbemaciclib
The 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
- RadiationRadiation Therapy
27Gy in 3 daily fractions or 30Gy in 5 daily fractions completed entirely within 28 days of simulation via stereotactic body radiotherapy (SBRT).
Outcome measures
Primary
Maximum tolerated dose/MTD of abemaciclib
The primary endpoint of the study is defining the MTD of abemaciclib in combination with Radiation Therapy/RT
Time frame: up to 1 year
Eligibility criteria
Study locations (7)
Memorial Sloan Kettering at Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553