CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 118 enrolled
Drug / intervention
Enzalutamidedrug
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/NCT01889238
NCT01889238Phase 2Completed
CompareCT.gov

A PHASE 2, SINGLE-ARM, OPEN-LABEL, MULTICENTER STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF ENZALUTAMIDE IN PATIENTS WITH ADVANCED, ANDROGEN RECEPTOR-POSITIVE, TRIPLE-NEGATIVE BREAST CANCER

Pfizer·interventional·Posted Jun 28, 2013·Updated Dec 13, 2024

In Brief

A Phase 2 clinical trial evaluating Enzalutamide for Advanced, Androgen Receptor Positive Triple Negative Breast Cancer. Completed, enrolled 118 participants across 132 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced, Androgen Receptor Positive Triple Negative Breast Cancer
CountriesBelgium, Canada, Ireland, Italy, Spain, United Kingdom, United States
CollaboratorsAstellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 28, 2013
Enrollment StartJun 12, 2013
Primary CompletionMar 1, 2015
Study CompletionJan 10, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.0 years ago

Interventions

Enzalutamidedrug

160 mg administered as four soft gelatin capsules orally once daily