CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 297 enrolled
Drug / intervention
Exemestane +2 moredrug
Likely dose
Not stated in 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/NCT01381874
NCT01381874Phase 2Completed
CompareCT.gov

Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy

Janssen Research & Development, LLC·interventional·Posted Jun 27, 2011·Updated Apr 11, 2019

In Brief

A Phase 2 clinical trial evaluating Exemestane, Abiraterone acetate + Prednisone/ Prednisolone + Exemestane, and 1 other intervention for Metastatic ER+ Her2- Breast Cancer and Postmenopausal. Completed, enrolled 297 participants across 81 sites in 12 countries.

Detailed Summary

The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in postmenopausal women with estrogen receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after treatment with letrozole or anastrozole.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic ER+ Her2- Breast Cancer, Postmenopausal
CountriesBelgium, France, Ireland, Luxembourg, Netherlands, Poland, Russia, South Korea, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 27, 2011
Enrollment StartAug 24, 2011
Primary CompletionJul 28, 2014
Study CompletionAug 8, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.0 years ago

Interventions

Exemestanedrug

Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets

Abiraterone acetate + Prednisone/ Prednisolone + Exemestanedrug

Prednisone or Prednisolone, type=equal, unit=mg, number=5, form=tablet, route=oral use. All drugs are taken once daily.

Abiraterone acetate + Prednisone or Prednisolonedrug

Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets