Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

A PHASE 1 OPEN-LABEL, DOSE ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ENZALUTAMIDE (FORMERLY MDV3100) IN PATIENTS WITH INCURABLE BREAST CANCER

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.

Inclusion Criteria:

• Histologically confirmed breast cancer with accompanying pathology report;
• Submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides
• Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);
• Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;
• Estimated life expectancy of at least 3 months

Exclusion Criteria:

• Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
• Pregnant or lactating;
• Known or suspected brain metastasis or leptomeningeal disease;
• History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;
• For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor.