Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer
Condition: Advanced, Androgen Receptor Positive Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Enzalutamide
Intervention description: 160 mg administered as four soft gelatin capsules orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 118.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; triple negative; androgen receptor positive

Summary:

      The purpose of this study is to determine if enzalutamide is safe and effective in the
      treatment of patients with advanced breast cancer that express the androgen receptor but do
      not express the estrogen or progesterone receptor and are not Her2 amplified.
    

Eligibility criteria:

        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.