A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

September 5, 2014

Primary Completion Date

February 28, 2017

Study Completion Date

January 30, 2024

Conditions
HER2 AmplifiedAdvanced Breast CancerHuman Epidermal Growth Factor Receptor 2 (HER2)
Interventions
DRUG

Enzalutamide

Capsules for oral administration

DRUG

Trastuzumab

Intravenous infusion (IV) or subcutaneous injection if it is standard of care within a country

Trial Locations (39)

1200

Site BE32016, Brussels

2650

Site BE32003, Edegem

2930

Site BE32013, Brasschaat

3000

Site BE32009, Leuven

4000

Site BE32007, Liège

6000

Site BE32001, Charleroi

15213

Site US10048, Pittsburgh

20132

Site IT39003, Milan

20141

Site IT39002, Milan

23100

Site IT39001, Sondrio

28050

Site ES34013, Madrid

28223

Site ES34014, Pozuelo de Alarcón

32605

Site US10074, Gainesville

33100

Site IT39021, Udine

33916

Site US10079, Fort Myers

37203

Site US10042, Nashville

37232

Site US10077, Nashville

37909

Site US10029, Knoxville

45242

Site US10072, Cincinnati

46202

Site US10004, Indianapolis

47014

Site IT39005, Meldola

60637

Site US10081, Chicago

63110

Site US10078, St Louis

73100

Site IT39008, Lecce

76104

Site US10076, Fort Worth

77030

Site US10082, Houston

90048

Site US10028, Los Angeles

92801

Site US10051, Anaheim

94115

Site US10035, San Francisco

02215

Site US10070, Boston

K1H 8L6

Site CA15022, Ottawa

M4N 3M5

Site CA15023, Toronto

S4T7T1

Site CA15028, Regina

S7N 4H4

Site CA15026, Saskatoon

G1S 4L8

Site CA15001, Québec

08035

Site ES34010, Barcelona

EH4 2XU

Site GB44003, Edinburgh

M20 4BX

Site GB44013, Manchester

NG5 1PB

Site GB44001, Nottingham

All Listed Sponsors
collaborator

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

INDUSTRY

lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT02091960 - A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer | Biotech Hunter | Biotech Hunter