- Participants must have histologically confirmed invasive breast cancer that is metastatic or not amenable for resection or radiation therapy with curative intent. Histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer
- Age ≥18 years (or per national guidelines)
- ECOG performance status 0-1
- Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+ and/or PR+), metastatic breast cancer
- Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption
Exclusion Criteria
- Concurrent therapy with other Investigational Products
- Prior therapy with any CDK inhibitor
Please contact Legacy Oncology Research for additional study inclusion/exclusion information.