Efficacy and Safety Study of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

September 30, 2016

Primary Completion Date

April 30, 2019

Conditions
Breast Cancer
Interventions
DRUG

Enzalutamide

Enzalutamide will be administered as four 40-mg capsules once daily (160 mg/day).

DRUG

Placebo

DRUG

Paclitaxel

Paclitaxel (90 mg/m2) will be administered by constant-rate intravenous infusion of ≤ 1 hour once weekly for 16 weeks. Dose reductions or alterations to the schedule are allowed to maintain patient safety.

Trial Locations (6)

10469

The Bronx

66606

Topeka

70006

Metairie

77030

Houston

98405

Tacoma

98801

Wenatchee

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Astellas Pharma Inc

INDUSTRY

collaborator

Medivation, Inc.

INDUSTRY

lead

Pfizer

INDUSTRY

NCT02929576 - Efficacy and Safety Study of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer | Biotech Hunter | Biotech Hunter