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.