Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

247

Participants

Timeline

Start Date

December 16, 2013

Primary Completion Date

September 23, 2016

Study Completion Date

August 23, 2024

Conditions
Breast Cancer
Interventions
DRUG

Enzalutamide

160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food.

DRUG

exemestane

25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet after unblinding) by mouth once daily after food.

DRUG

Placebo (for enzalutamide)

Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.

DRUG

exemestane

50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) by mouth once daily after food.

Trial Locations (135)

4

Pharmacy Department, Dublin

Radiology Department, Dublin

St Vincent's University Hospital, Dublin

7

Institute for Cancer Research, Dublin

Mater Private Hospital, Dublin

Pharmacy Department, Dublin

Radiology Department, Dublin

1000

Institut Jules Bordet, Brussels

2610

GZA, Wilrijk

2650

UZA, Edegem

10065

Memorial Sloan Kettering Cancer Center, New York

20132

IRCCS Ospedale San Raffaele, Milan

20141

Divisione di Senologia Medica; Istituto Europeo di Oncologia, Milan

23116

Virginia Cancer Institute, Mechanicsville

23230

Virginia Cancer Institute, Richmond

23235

Virginia Cancer Institute, Richmond

28034

Hospital Universitario Ramon Y Cajal, Madrid

28041

Hospital Universitario 12 Octubre, Madrid

28050

Centro Integral Oncologico Clara Campal, Madrid

Hospital de Madrid Norte Sanchinarro, Madrid

28660

Hospital Universitario HM Monteprincipe, Boadilla del Monte

29307

Greenville Health System, Spartanburg

29605

Greenville Health System, Greenville

29672

Greenville Health System, Seneca

32605

Florida Cancer Specialists, Gainesville

32701

Florida Cancer Specialists, Altamonte Springs

32763

Florida Cancer Specialists, Orange City

32778

Florida Cancer Specialists, Tavares

32806

Florida Cancer Specialists, Orlando

33511

Florida Cancer Specialists, Brandon

33607

Florida Cancer Specialists, Tampa

33705

Florida Cancer Specialists, St. Petersburg

33761

Florida Cancer Specialists, Clearwater

33770

Florida Cancer Specialists, Largo

33901

Florida Cancer Specialists, Fort Myers

33905

Florida Cancer Specialists, Fort Myers

33908

Florida Cancer Specialists, Fort Myers

33909

Florida Cancer Specialists, Cape Coral

33980

Florida Cancer Specialists, Port Charlotte

34102

Florida Cancer Specialists, Naples

34135

Florida Cancer Specialists, Bonita Springs

34209

Florida Cancer Specialists, Bradenton

34223

Florida Cancer Specialists, Englewood

34232

Florida Cancer Specialists, Sarasota

34236

Florida Cancer Specialists, Sarasota

34285

Florida Cancer Specialists, Venice

34292

Florida Cancer Specialists, Venice

34608

Florida Cancer Specialists, Spring Hill

34655

Florida Cancer Specialists, New Port Richey

34667

Florida Cancer Specialists, Hudson

37066

Tennessee Oncology, PLLC, Gallatin

37067

Tennessee Oncology, PLLC, Franklin

37076

Tennessee Oncology, PLLC, Hermitage

37090

Tennessee Oncology, PLLC, Lebanon

37129

Tennessee Oncology, PLLC, Murfreesboro

37160

Tennessee Oncology, PLLC, Shelbyville

37167

Tennessee Oncology, PLLC, Smyrna

37203

Tennessee Oncology, PLLC, Nashville

The Sarah Cannon Research Institute, Nashville

37204

Vanderbilt Breast Center at One Hundred Oaks, Nashville

Vanderbilt Health Pharmacy One Hundred Oaks, Nashville

37207

Tennessee Oncology, PLLC, Nashville

37211

Tennessee Oncology, PLLC, Nashville

37232

Henry-Joyce Cancer Clinic, Nashville

38104

The West Clinic, P.C. d/b/a West Cancer Center, Memphis

38138

The West Clinic, P.C. d/b/a West Cancer Center, Germantown

38671

The West Clinic, P.C. d/b/a West Cancer Center, Southaven

38834

The West Clinic, P.C., Corinth

40138

Azienda Ospedaliera S.Orsola Malpighi, Bologna

45014

Oncology Hematology Care, Inc., Fairfield

45202

Oncology Hematology Care, Inc., Cincinnati

45211

Oncology Hematology Care, Inc., Cincinnati

45230

Oncology Hematology Care, Inc., Cincinnati

45236

Oncology Hematology Care, Inc., Cincinnati

45242

Oncology Hematology Care, Inc., Cincinnati

46202

Indiana University Health Hospital, Indianapolis

Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis

Investigational Drug Services, Indianapolis

Sidney and Lois Eskenazi Hospital, Indianapolis

46290

Springmill Medical Clinic, Indianapolis

55404

Minnesota Oncology Hematology, P.A, Minneapolis

55407

Abbott Northwestern Hospital, Minneapolis

Allina Health System DBA Virginia Piper Cancer Institute, Minneapolis

Dr.Michaela Tsai, Minneapolis

59100

U.O. Farmaceutica, Nuovo Ospedale di Prato, Prato

U.O. Oncologia Medica, Nuovo Ospedale di Prato, Prato

60451

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital, New Lenox

60611

Northwestern Medical Faculty Foundation, Chicago

Northwestern Memorial Hospital, Chicago

60637

The University of Chicago Medical Center,, Chicago

The University of Chicago, Chicago

63110

Barnes-Jewish Hospital, St Louis

Washington University Infusion Center Pharmacy, St Louis

Washington University School of Medicine, St Louis

63129

Siteman Cancer Center-South County, St Louis

63141

Siteman Cancer Center- West County, St Louis

63376

Siteman Cancer Center, City of Saint Peters

75601

Texas Oncology-Longview Cancer Center, Longview

75702

Texas Oncology - Tyler, Tyler

77024

Texas Oncology - Memorial City, Houston

80045

ATTN-Research Pharmacist, Aurora

University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora

University of Colorado Hospital, Anschutz Outpatient Pavilion, Aurora

80124

Rocky Mountain Cancer Centers, Lone Tree

80228

Rocky Mountain Cancer Centers, Lakewood

80907

Rocky Mountain Cancer Centers, Colorado Springs

02115

Brigham and Women's Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

07962

Hematology Oncology Associates of Northern NJ, Morristown

M4N 3M5

Sunnybrook Research Institute, Toronto

H4A 3J1

McGill University Health Center- Cedars Cancer Center, Montreal

McGill University Health Centre - Cedars Cancer Centre, Montreal

D9

Cancer Clinical Trials Unit, Dublin

Pharmacy Department, Dublin

Radiology Department, Dublin

Unknown

Institute for Cancer Research, Dublin

Mater Private Hospital, Dublin

Pharmacy Department, Dublin

Radiology Department, Dublin

06132

A.O.di Perugia S. Maria Della Misericoridia, Perugia

00144

Dipartimento di Oncologia Medica, Istituto Nazionale Tumori Regina Elena, Roma

08028

Grupo Hospitalario Quiron - Hospital Universitari Quiron Dexeus, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

BN2 5BE

Brighton and Sussex University Hospital NHS Trust, Brighton

Pharmacy Department, Brighton

Radiation Safety Service, Medical Physics Department, Brighton

Clinical Investigation & Research Unit, Brighton

NG5 1PB

Histopathology Department, Nottingham

Nottingham University Hospital, Nottingham

Pharmacy Department, Nottingham

Radiology Department, Nottingham

NG7 2UH

Radiology Department, Nottingham

TR1 3LJ

Department of Radiology, Truro

Pharmacy Department, Truro

Royal Cornwall Hospitals NHS trust, Truro

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Astellas Pharma Inc

INDUSTRY

collaborator

Medivation, Inc.

INDUSTRY

lead

Pfizer

INDUSTRY