ARB

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
Disease site: Breast cancer
Status: Follow up

Trial Design: Open-label, international, multicentre window of opportunity phase II trial to evaluate the effects of short-term preoperative therapy with enzalutamide (alone or in combination with exemestane) in women with newly diagnosed invasive primary breast cancer. The study has two cohorts, an oestrogen receptor positive breast cancer cohort and an androgen receptor positive, triple-negative breast cancer cohort.  Participants will receive treatment for 15 to 29 days, until either surgery or primary medical treatment (e.g. neoadjuvant chemotherapy) at the discretion of the treating physician. The effects of enzalutamide (alone or in combination with exemestane) will be assessed on tumour tissue specimens taken at baseline and on the last day of study treatment.

Trial details

Chief Investigator: Prof P. Schmid
Trial contact: bci-arb@qmul.ac.uk
Clinical Trials.gov: NCT02676986
EudraCT: 2014-002001-37
Sponsor: Queen Mary University of London
Participating countries: UK, Germany, Spain, USA
Source of funding: F Astellas Pharma Ltd (funding and study drug)

Publications and presentations

ARB: Phase II window of opportunity study of short-term preoperative treatment with enzalutamide in ER-positive and triple-negative breast cancer. Peter Schmid, Duncan A Wheatley, Alastair Mark Thompson et al. Journal of Clinical Oncology (2016) 34:15_suppl, TPS619-TPS619

Patient friendly information

Cancer Research UK website A trial looking at enzalutamide for early stage breast cancer (ARB)

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