Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer

Inclusion Criteria

• •The study population for Step 1 must meet the following eligibility criteria:
• •Stage 1, 2 or 3 invasive breast cancer which is triple negative. Triple negative breast cancer is defined as ER \<1, PR \<1 and HER2 0 or 1+ or FISH not amplified if IHC 2+.
• •AR testing may be performed while patient is undergoing other adjuvant therapy (i.e., surgery, chemotherapy, radiation).
• •Willing and able to provide informed consent. Woman at least 18 years of age.
• •Patient is a candidate for treatment of their early stage breast cancer.
• •The study population for Step 2 will meet the eligibility criteria:
• •Stage 1, 2 or 3 invasive breast cancer which is triple negative. Triple negative breast cancer is defined as ER \<1%, PR \<1% and HER2 0 or 1+ or FISH not amplified if IHC 2+.
• •AR(+), defined as ≥1% nuclear staining by IHC testing. The assessment of AR expression may have been performed any time in the past and is not limited to participation in Step 1.
• •Any neoadjuvant or adjuvant chemotherapy regimen is permitted. Prior chemotherapy for the treatment of this breast cancer is not required.
• •At least 4 weeks from end of surgery, chemotherapy, or radiotherapy with resolution of any toxicity to Grade 1 or less, excluding alopecia.
• •Patients are eligible to participate within 6 months of completion of therapy for their breast cancer. This includes prior radiation therapy if needed.
• •ECOG performance status of 0 or 1.
• •Willing and able to provide informed consent.
• •Woman at least 18 years of age.
• •Able to swallow study drug and comply with study requirements.
• •Women of childbearing potential must have a negative pregnancy test and must agree to use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration.
• •Is not breastfeeding at screening and will not breastfeed throughout the study period and for at least 3 months after final drug administration.