ARB v1.0
Research type
Research Study
Full title
Phase II window of opportunity study of short term preoperative treatment with enzalutamide (alone or in combination with exemestane) in patients with primary breast cancer.
IRAS ID
165351
Contact name
Peter Schmid
Contact email
Sponsor organisation
Queen Mary University London
Eudract number
2014-002001-37
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
This study is being carried out to see if the anti-androgen enzalutamide has anti-tumour effects in early breast cancer. Enzalutamide blocks the action of androgens on the androgen receptor (AR) and may slow down or stop breast cancers growing. Enzalutamide is approved for the treatment of prostate cancer.
The trial will be offered to patients who have just been diagnosed with early breast cancer and who are planned to have surgery in the next few weeks. The treatment will bridge the time between the diagnosis and surgery and will be given for 2-4 weeks. To assess the effect of the treatment, small samples of breast cancer tissue will be analysed before the start and after treatment. The pre-treatment assessment will be done on archived tissue but patients might require an additional biopsy, if sufficient stored tumour tissue is not available. The end-of-treatment samples will be taken during surgery, unless the patient will receive medical treatment first instead of surgery which might mean additional biopsies of the breast cancer have to be taken.
The trial has two cohorts. The cohort of patients with oestrogen-receptor (ER) positive breast cancer will test if adding enzalutamide to exemestane is better at slowing the growth of breast cancer than exemestane alone. This cohort will recruit 141 evaluable postmenopausal patients with a tumour size of at least 1 cm. The aromatase inhibitor exemestane is approved for the treatment of ER-positive breast cancer. Blocking aromatase decreases oestrogens but can increase androgens. Enzalutamide is therefore added to block the action of androgens on the AR.
In the second cohort of patients with triple negative breast cancer (TNBC), enzalutamide will be given alone to see if it can slow the growth tumours with androgen receptors. As only approximately 30% of TNBCs express the AR, a prescreening step will be included to test the tumour AR expression, before patients are approached for the ARB trial. The TNBC cohort will comprise 55 patients.REC name
London - City & East Research Ethics Committee
REC reference
14/LO/2195
Date of REC Opinion
3 Mar 2015
REC opinion
Further Information Favourable Opinion