CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 247 enrolled
Drug / intervention
Enzalutamide +3 moredrug
Likely dose
Enzalutamide 160 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02007512
NCT02007512Phase 2Completed
CompareCT.gov

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

Pfizer·interventional·Posted Dec 10, 2013·Updated Sep 2, 2025

In Brief

A Phase 2 clinical trial evaluating Enzalutamide, exemestane, and 1 other intervention for Breast Cancer. Completed, enrolled 247 participants across 135 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesBelgium, Canada, Ireland, Italy, Spain, United Kingdom, United States
CollaboratorsAstellas Pharma Inc, Medivation, Inc.

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 10, 2013
Enrollment StartDec 16, 2013
Primary CompletionSep 23, 2016
Study CompletionAug 23, 2024
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.6 years ago

Interventions

Enzalutamidedrug

160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food.

exemestanedrug

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.

Placebo (for enzalutamide)drug

Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.

exemestanedrug

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.