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

Prior treatment

• Any severe concurrent disease, infection, or comorbid condition;
• Current or previously treated brain metastasis or active leptomeningeal disease;
• Current hormone replacement therapy;
• Local palliative radiation therapy within 7 days before day 1;
• 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;

Other illness

• 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;
• History of another invasive cancer within 5 years of day 1;
• History of seizure or any condition that may predispose to seizure;
• Clinically significant cardiovascular disease;
• Active gastrointestinal disorder affecting absorption;
• Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.

Lab values

• 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;

• 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.