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Brief Title: AKT Inhibitor in Oestrogen Positive Breast Cancer
Official Title: The Short Term Effects of an AKT Inhibitor (AZD5363) on Biomarkers of the AKT Pathway and Anti-tumour Activity in a Breast Cancer Paired Biopsy Study
Study ID: NCT02077569
Brief Summary: To compare the effect of four and a half days treatment of a range of doses of AZD5363 on selected markers of the AKT pathway and anti-proliferation compared with placebo in oestrogen receptor positive breast cancers. To assess the tolerability of four and a half days treatment of AZD5363.
Detailed Description: The principal research questions to be addressed are whether (or not) AZD5363 is "hitting its therapeutic target" sufficiently and to the extent that is required to produce efficacy in pre-clinical experiments. The primary endpoint markers have been selected to determine this. Reductions in markers of the AKT pathway and increases in markers of anti-proliferation will characterise the degree of biological activity arising from the inhibition of AKT across a range of doses of AZD5363.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Royal Derby Hospital, Derby, Derbyshire, United Kingdom
Plymouth Hospitals NHS Trust, Derriford, Plymouth, Devon, United Kingdom
Royal Bournemouth Hospital, Bournemouth, Dorset, United Kingdom
Poole Hospital NHS Foundation Trust, Poole, Dorset, United Kingdom
Leicester Royal Infirmary, Leicester, Leicestershire, United Kingdom
Western General Hospital, Edinburgh, Lothian, United Kingdom
Royal Liverpool University Hospital, Liverpool, Merseyside, United Kingdom
Kingsmill Hospital, Sutton-in-Ashfield, Nottinghamshire, United Kingdom
Sheffield Cancer Research Centre, Sheffield, South Yorkshire, United Kingdom
University Hospital Birmingahm, Birmingham, West Midlands, United Kingdom
Leeds St James Institue of Oncology, Leeds, West Yorkshire, United Kingdom
Name: John FR Robertson, MD
Affiliation: University of Nottingham
Role: STUDY_CHAIR