- 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.
- 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 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.