Conditions: Breast Cancer
Keywords: enzalutamide MDV3100 breast cancer
Allocation: NON_RANDOMIZED | Intervention model: 
Enrollment: 101
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.

Detailed description:

Arms:
arm 1: enzalutamide be provided as two or four 40-mg capsules by mouth daily arm 2: enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with anastrozole (1 mg) administered as one 1-mg tablet by mouth once daily. arm 3: enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as one 25-mg tablet daily arm 4: enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as two 25-mg tablets daily arm 5: enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with fulvestrant (500 mg) administered as two 250-mg intramuscular injections every 28 days

Interventions: intervention 1: enzalutamide intervention 2: anastrozole intervention 3: exemestane intervention 4: fulvestrant intervention 5: enzalutamide intervention 6: exemestane
Intervention descriptions: intervention 1: 80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily. intervention 2: 1 mg/day intervention 3: The exemestane dose is 25mg daily. intervention 4: 500 mg every 28 days intervention 5: 160 mg (4 capsules) taken orally daily. intervention 6: The exemestane dose is 50 mg daily.

Protocol document: