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.