drugset / Trial / NCT01381874

A Study of Abiraterone Acetate Plus Prednisone With or Without Exemestane in Postmenopausal Women With Estrogen Receptor-Positive (ER+) Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy

NCT01381874

Phase 2 Completed 297 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-08-24
Primary completion
2014-07-28
Completion
2018-08-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule 1000 mg Oral
Subject Exemestane Small molecule 25 mg Oral
Subject Prednisolone Other / unclassified 5 mg Oral
Subject Prednisone Other / unclassified 5 mg Oral