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

PHASE2CompletedINTERVENTIONAL
Enrollment

297

Participants

Timeline

Start Date

August 24, 2011

Primary Completion Date

July 28, 2014

Study Completion Date

August 8, 2018

Conditions
Metastatic ER+ Her2- Breast CancerPostmenopausal
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

Trial Locations (81)

Unknown

Muscle Shoals

Fresno

Los Angeles

Monterey

Chicago

Waterville

Boston

Ann Arbor

Henderson

East Syracuse

Johnson City

New York

Durham

Fargo

Cleveland

Columbus

Kettering

Portland

Sioux Falls

Dallas

El Paso

Houston

Tyler

Seattle

Antwerp

Brussels

Duffel

Edegem

Ghent

Hasselt

Leuven

Liège

Wilrijk

Bordeaux

Caen

Pierre-Bénite

Saint-Cloud

Saint-Herblain

Galway

Limerick

Luxembourg

Niedercorn

Alkmaar

Amsterdam

Heerlen

Leeuwarden

Leiden

Rotterdam

Sittard

Bialystok

Warsaw

Chelyabinsk

Kazan'

Leningrad Region

Moscow

Saint Petersburg

Sochi

Stavropol

Vladimir

Busan

Seoul

Suwon

Barcelona

Madrid

Seville

Valencia

Cherkasy

Chernivtsi

Dnipro

Donetsk

Kharkiv

Odesa

Uzhhorod

Bath

Birmingham

Exeter

London

Nottingham

Plymouth

Sheffield

Sutton

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

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 | Biotech Hunter | Biotech Hunter