- Trial statusAnalysis
- Study email firstname.lastname@example.org
- Chief InvestigatorCarlo Palmieri
- SponsorImperial College London
A phase II, open label, preoperative study to assess the efficacy of the novel steroid sulfatase inhibitor Irosustat in postmenopausal women with early oestrogen receptor positive breast cancer.
Design and Objective
A multi-centre, single arm, open label, non-randomised, pre-operative, phase II study. The study will involve the methodological application of FLT-PET to assess the efficacy of Irosustat in early oestrogen receptor positive, treatment naïve patients with breast cancer, by measuring changes in thymidine transport and phosphorylation.
Key inclusion criteria
18 years of age or older Postmenopausal Histologically confirmed ER +ve breast cancer (Allred >3). Tumour measuring ≥15mm in longest diameter ECOG performance status 0, 1 or 2 Adequate bone marrow, renal and liver function No evidence of bleeding diathesis Written informed consent to participate in the trial and to donate tissue and blood samples