Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer

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.

Timeline

Start

2013-12-16

Primary completion

2016-09-23

Completion

2024-08-23

Outcome

Mixed primary results

registry Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg vs Cohort 1: Placebo + Exemestane 25 mg; p = 0.3631 NCT02007512 ↗

registry Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg vs Cohort 1: Placebo + Exemestane 25 mg; p = 0.0335 NCT02007512 ↗

registry Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg vs Cohort 2: Placebo + Exemestane 25 mg; p = 0.1936 NCT02007512 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enzalutamide	Other / unclassified	160 mg	Oral
Subject	Exemestane	Small molecule	25 mg	Oral
Subject	Exemestane	Small molecule	50 mg	Oral

Indications