EMERALD
Research type
Research Study
Full title
A window of opportunity study to assess the biological effects of enobosarm in oestrogen receptor positive, androgen receptor positive early breast cancer
IRAS ID
200415
Contact name
Carlo Palmieri
Contact email
Eudract number
2016-000543-13
Duration of Study in the UK
1 years, 2 months, 28 days
Research summary
Breast cancer (BC) is a leading cause of morbidity and mortality in the UK with 49,936 new cases and 11,762 deaths in 2011. BC is a heterogeneous disease which may be classified by gene expression profiles or immunohistochemical biomarkers. One key subtype (80% of BC) is defined by the expression of the nuclear transcription factor estrogen receptor alpha (herein referred to as ER. Hence, endocrine therapies that aim to inhibit ER activity represent a cornerstone strategy in the management of ER positive (ER+) BC. The majority of ER+ BC are diagnosed as early stage disease and are treated with curative intent by surgery followed by various combinations of adjuvant chemotherapy, radiotherapy, and trastuzumab (if HER2+ and receiving chemotherapy). All women diagnosed with ER+ BC should receive endocrine therapy (ET), and the introduction and widespread use of adjuvant tamoxifen and subsequently in the postmenopausal population aromatase inhibitors (AIs) have resulted in significant improvements in the overall survival of women with ER+ early BC.
Despite these improvements, 30% of patients will suffer relapse, due to inherent or acquired resistance to ET. These women inevitably die of metastatic breast cancer (MBC). While the introduction and use of agents which target resistance mechanisms implicated in endocrine resistance such as trastuzumab, everolimus and palboclilib have improved the efficacy of ET when used in combination in the metastatic setting, resistance to ET remains a major clinical problem. Therefore, continued clinical and translational research into potential novel endocrine therapies as well as strategies to enhance the effectiveness of currently available therapies is required if outcomes in both early and metastatic disease are to be significantly improved.
EMERALD aims to determine the effect of enobosarm, a selective androgen receptor modulator, using a "window of opportunity study" in 146 patients across NHS sites in the UK.
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0807
Date of REC Opinion
28 Dec 2016
REC opinion
Further Information Favourable Opinion