This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspects of the study
Women aged at least 18 years
The patient has a biopsy-confirmed diagnosis of recurrent, unresectable, locally advanced, or metastatic HER2neu-negative breast cancer (including bone-only metastatic disease) o The patient must have had biopsy confirmation of a metastatic site (with appropriate ER/PR/HER2neu IHC staining)
Any investigational agents or study drugs from a previous clinical study within 28 days of the first dose of study treatment
Any other chemotherapy, immunotherapy or anticancer agents within 21 days of the first dose of study treatment
Any prior exposure to anti-androgen therapy (bicalutamide, abiraterone, and/or enzalutamide)
Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment