Enzalutamide in Triple Negative Breast Cancer
Research type
Research Study
Full title
A Phase 2, Single Arm, Open Label, Multicenter Study of the Clinical Activity and Safety of Enzalutamide in Patients With Advanced, Androgen Receptor Positive, Triple Negative Breast Cancer
IRAS ID
128669
Contact name
Peter Schmid
Contact email
Sponsor organisation
Medivation, Inc.
Eudract number
2013-000698-57
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
The present study is a multicentre, multinational, single arm, open label phase 2 study of the clinical activity and safety of enzalutamide in patients with sdvanced, androgen receptor positive, triple negative breast cancer. Breast cancer is the most common malignancy in women and is the leading cause of cancer-related death in European women. Triple-negative breast cancer remains the subtype with poorest outcome and there is a significant need to develop new therapies for this group of patients
The purpose of this study is to determine if enzalutamide is a potential treatment for women that have been diagnosed with triple-negative breast cancer that expresses the androgen receptor (is androgen receptor-positive). This study is also being done to test the safety and tolerability of enzalutamide in this group of patients.
Enzalutamide is approved by the United States Food and Drug Administration (FDA) for men with prostate cancer who previously received docetaxel therapy. Enzalutamide is an investigational medicine for breast cancer. Enzalutamide received a positive opinion on 26 Apr 2013 from CHMP (The Committee for Medicinal Products for Human Use)
Eligible Patients will take enzalutamide (4 capsules or 160 mg) once per day by mouth during the treatment period, which starts on study Day 1. The treatment period will end when the study doctor decides that patients should stop taking enzalutamide, if they start a new cancer therapy or clinical trial, or if they want to stop taking enzalutamide. After patients stop taking enzalutamide, they will have a study visit about 30 days after their last dose as well as long term follow up every 3 to 6 months after last dose. Tests will be conducted by the doctor during this time to monitor health, including physical examinations, blood/urine samples, and CT or MRI scans.
About 80 patients will be enrolled into this study across 40 to 45 study centers in North America and Europe.REC name
London - City & East Research Ethics Committee
REC reference
13/LO/0908
Date of REC Opinion
1 Sep 2013
REC opinion
Further Information Favourable Opinion