Conditions: Breast Cancer
Keywords: advanced breast cancer enzalutamide MDV3100 Estrogen receptor positive (ER +) Progesterone receptor positive (PgR +) HER-2 normal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 247
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.

Detailed description:
This is a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2-Normal.

Arms:
arm 1: Enzalutamide 160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food and exemestane 50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) once daily after food. arm 2: Placebo and exemestane 25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet without placebo after unblinding) once daily after food.

Interventions: intervention 1: Enzalutamide intervention 2: exemestane intervention 3: Placebo (for enzalutamide) intervention 4: exemestane
Intervention descriptions: intervention 1: 160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food. intervention 2: 25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet after unblinding) by mouth once daily after food. intervention 3: Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food. intervention 4: 50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) by mouth once daily after food.

Protocol document: