Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer

Inclusion Criteria:

Women at least 18 years of age;
Advanced AR+ TNBC;
Availability of a representative tumor specimen:
Either measurable disease or bone only nonmeasurable disease;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

Any severe concurrent disease, infection, or comorbid condition;
Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data;
Current or previously treated brain metastasis or active leptomeningeal disease;
Current hormone replacement therapy;
Local palliative radiation therapy within 7 days before day 1;
History of another invasive cancer within 5 years of day 1;
Absolute neutrophil count < 1500/µL, platelet count < 75,000/µL, or hemoglobin < 9 g/dL (5.6 mmol/L) at the screening visit;
Creatinine > 1.5 times upper limit of normal (ULN) at the screening visit;
History of seizure or any condition that may predispose to seizure;
Clinically significant cardiovascular disease;
Active gastrointestinal disorder affecting absorption;
Major surgery within 4 weeks before day 1;
Treatment with any commercially available anticancer agent within 14 days before day 1;
Treatment with any investigational agent within 2 weeks before day 1;
Treatment with any of the following medications within 2 weeks before day 1: Estrogens, including hormone replacement therapy; Androgens (testosterone, dihydroepiandrosterone, etc);Systemic radionuclides (eg, samarium or strontium);Vaccine therapy;
Hypoglycemic episode requiring medical intervention while on insulin treatment within 12 months before day 1;
Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.