West Cancer Center

BREAST: Metastatic; ER/PR+; HER2-; >=3rd line; AR+; "MDV3100-08"

A phase 1 open-label, dose escalation study evaluating the safety, tolerability, and pharmacokinetsic of MDV3100 in patients with incurable breast cancer

Title

Medivation MDV3100-08

Study Title

A phase 1 open-label, dose escalation study evaluating the safety, tolerability, and pharmacokinetsic of MDV3100 in patients with incurable breast cancer

Site Link

NCT01597193

Malignancy

Breast, Metastatic Breast Cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

3rd or higher systemic therapy (Endocrine therapy counts as systemic therapy)

Investigational Agent

Enzalutamide

Drug Class

AR 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/NCT01597193?term=MDV3100-08&rank=1

Key Eligibility Criteria Details

AR positive breast cancer(10% or greater staining)
ER/PR positive
HER2 negative
Currently receiving fulvestrant (have receivedat least 3 doses)
At least 2 lines of prior therapy
ECOG PS 0-1
No CNS involvement

Objective

Primary- Safety: Secondary- PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

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

Dosing Frequency

Enzalutamide orally daily; fulvestrant q28 days

Control Agents

N/A

Study Protocol

Randomized