Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

December 15, 2015

Study Completion Date

January 22, 2018

Conditions
Breast Cancer
Interventions
DRUG

enzalutamide

80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.

DRUG

anastrozole

1 mg/day

DRUG

exemestane

The exemestane dose is 25mg daily.

DRUG

fulvestrant

500 mg every 28 days

DRUG

enzalutamide

160 mg (4 capsules) taken orally daily.

DRUG

exemestane

The exemestane dose is 50 mg daily.

Trial Locations (17)

10022

Memorial Sloan Kettering Cancer Center, New York

10065

Memorial Sloan Kettering Cancer Center - IDS Pharmacy, New York

Memorial Sloan Kettering Cancer Center - OPD Pharmacy, New York

Memorial Sloan Kettering Cancer Center, New York

34232

Florida Cancer Specialists, Sarasota

37203

Tennessee Oncology, PLLC., Nashville

The Sarah Cannon Research Institute, Nashville

38104

The West Clinic, Memphis

38120

The West Clinic, Memphis

38138

The West Clinic, Germantown

38671

The West Clinic, Southaven

38834

The West Clinic, PC, Corinth

48201

Karmanos Cancer Institute, Detroit

80045

ATTN-Research Pharmacist, Aurora

University of Colorado Cancer Center, Aurora

University of Colorado Hospital, Anschutz Outpatient Pavilion, Aurora

06082

Connecticut Multispecialty Group, Enfield

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Astellas Pharma Inc

INDUSTRY

collaborator

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

INDUSTRY

lead

Pfizer

INDUSTRY

NCT01597193 - Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer | Biotech Hunter | Biotech Hunter