West Cancer Center

BREAST: Metastatic; ER/PR+; HER2-; 1st-2nd line: "MDV3100-12"

A phase 2, randomized, double-blind, placebo-controlled, multicenter study of efficacy and safety of enzalutamide in combination with exemestane in patients with advanced breast cancer that is estrogen or progesterone receptor-postiive and HER2-normal

Title

Medivation MDV3100-12

Study Title

Site Link

NCT02007512

Malignancy

Breast, Metastatic Breast Cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st or 2nd

Investigational Agent

Enzalutamide

Drug Class

Androgen receptor antagonist

Lee Schwartzberg, MD

Sponsor

Medivation Inc, Astellas Pharmaceuticals

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02007512?term=MDV3100-12&rank=1

Key Eligibility Criteria Details

Up to one prior hormone therapy allowed
Up to one prior chemotherapy allowed
ER/PR+
HER2-
Available pathological specimen
No prior exemestane

Objective

Primary- PFS: Secondary- CBR, PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ER/PR positive (+)HER2 negative (-)

Dosing Frequency

Enzalutamide 160mg/day, Exemestane 25 or 50mg/day

Control Agents

Placebo and exemestane

Study Protocol

Randomized

Yes