A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer
Memorial Sloan Kettering Cancer Center
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Documented estrogen receptor (ER) positive and/or progesterone receptor (PgR) positive by immunohistochemistry. The threshold to qualify as ER or PgR positive is ≥1% per ASCO/CAP guidelines. * HER2 negative tumor status confirmed by immunohistochemistry or FISH per ASCO/CAP guidelines. * Any line of prior treatments (hormonal therapy and chemo…