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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2019-04-11

Study results available
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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.

Conditions

  • Metastatic ER+ Her2- Breast Cancer
  • Postmenopausal

Interventions

DRUG

Exemestane

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

DRUG

Abiraterone acetate + Prednisone/ Prednisolone + Exemestane

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

DRUG

Abiraterone acetate + Prednisone or Prednisolone

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States
  • Belgium
  • France
  • Ireland
  • Luxembourg
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01381874 on ClinicalTrials.gov