GTx G200901 - GTx-024(Enobosarm) on AR+ Triple Negative Breast Cancer
Research type
Research Study
Full title
A Phase 2 Open Label, Multi-Center, Multinational Study Investigating The Efficacy and Safety Of GTx-024 On Advanced, Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC)
IRAS ID
172320
Contact name
Carlo Palmieri
Contact email
Sponsor organisation
GTx, Inc.
Eudract number
2014-004989-23
Duration of Study in the UK
2 years, 1 months, 7 days
Research summary
Breast cancer is the most common cause of cancer death among women, representing 522,000 deaths in 2012 and the most frequently diagnosed cancer among women in 140 of 184 countries worldwide. Around 10% of women diagnosed with breast cancer will have Triple negative breast cancer (TNBC) which is characterized by a lack of expression of ER, progesterone receptor (PgR) or HER2. For those patients with TNBC treatment options are limited therefore research is focused on identifying novel therapeutic targets in TNBC. One such target is the androgen receptor (AR).
This study will examine if a new drug called GTx-024 (Enobosarm) which binds to the androgen receptor can help patients with advanced metastatic androgen receptor-positive triple negative breast cancer (AR+ TNBC). The purpose of this study is to estimate the clinical benefit (via disease control) of Enobosarm given daily as an oral capsules (at the dose of 18mg) in patients with AR+ TNBC.
The study is intended to be run in several countries in Europe (Bulgaria, Hungary, Czech Republic, Lithuania, Romania, UK, Ukraine) and USA and include 21 to 55 patients with a treatment period of 12 months.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0305
Date of REC Opinion
25 Aug 2015
REC opinion
Further Information Favourable Opinion