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Brief Title: Trial of Perioperative Endocrine Therapy - Individualising Care
Official Title:
Study ID: NCT02338310
Brief Summary: To determine whether perioperative endocrine therapy with an aromatase inhibitor (AI) followed by standard adjuvant therapy improves outcome compared with standard adjuvant therapy alone in postmenopausal women with hormone receptor positive breast cancer. To determine whether the proliferation marker Ki67 as measured by immunohistochemistry (IHC) in the excised cancer around 2 weeks after starting AI therapy will predict for time to recurrence (TTR) in the individual patient more effectively than the pre-treatment Ki67 value. To determine whether molecular profiling 2 weeks after starting endocrine therapy predicts for long-term outcome in postmenopausal women with hormone receptor positive breast cancer better than at diagnosis.
Detailed Description:
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Ulster Hospital, Dundonald, Belfast, United Kingdom
Heatherwood and Wexham Park Hospitals NHS trust, Slough, Berkshire, United Kingdom
Stoke Mandeville Hospital, Aylesbury, Buckinghamshire, United Kingdom
Prince Philip Hospital, Llanelli, Carmarthenshire, United Kingdom
Craigavon Area Hospital, Portadown, Co.Amagh, United Kingdom
Wansbeck General Hospital, Ashington, England, United Kingdom
North Devon District Hospital, Barnstaple, England, United Kingdom
City Hospital - Birmingham, Birmingham, England, United Kingdom
Royal Blackburn Hospital, Blackburn, England, United Kingdom
Pilgrim Hospital, Boston, England, United Kingdom
Bradford Teaching Hospitals NHS Trust, St Luke's Hospital, Bradford, England, United Kingdom
Burnley General Hospital, Burnley, England, United Kingdom
Cumberland Infirmary, Carlisle, England, United Kingdom
Chelmsford and Essex Centre, Chelmsford, England, United Kingdom
Chesterfield Royal Hospital, Chesterfield, England, United Kingdom
Countess of Chester Hospital, Chester, England, United Kingdom
Essex County Hospital, Colchester, England, United Kingdom
Doncaster Royal Infirmary, Doncaster, England, United Kingdom
Russells Hall Hospital, Dudley, England, United Kingdom
Wycombe General Hospital, High Wycombe, England, United Kingdom
Airedale General Hospital, Keighley, England, United Kingdom
Kidderminster Hospital, Kidderminster, England, United Kingdom
Whittington Hospital, London, England, United Kingdom
Royal Free Hospital, London, England, United Kingdom
Guy's Hospital, London, England, United Kingdom
King's College Hospital, London, England, United Kingdom
Royal Marsden - London, London, England, United Kingdom
St. Mary's Hospital, London, England, United Kingdom
Wythenshawe Hospital, Manchester, England, United Kingdom
North Manchester General Hospital - Penine Actute Hospitals Trust, Manchester, England, United Kingdom
North Tyneside Hospital, North Shields, England, United Kingdom
Northampton General Hospital NHS Trust, Northampton, England, United Kingdom
George Eliot Hospital, Nuneaton, England, United Kingdom
Royal Oldham Hospital, Oldham, England, United Kingdom
Poole Hospital, Poole Dorset, England, United Kingdom
Royal Berkshire Hospital, Reading, England, United Kingdom
University Hospital of North Staffordshire, Stoke-On-Trent, England, United Kingdom
Royal Marsden Hosital,, Sutton, England, United Kingdom
Southend NHS Trust Hospital, Westcliff-On-Sea, England, United Kingdom
Royal Hampshire County Hospital, Winchester, England, United Kingdom
New Cross Hospital, Wolverhampton, England, United Kingdom
Worcester Royal Hospital, Worcester, England, United Kingdom
Yeovil District Hospital, Yeovil, England, United Kingdom
St Margaret's Hospital, Epping, Essex, United Kingdom
Cheltenham General Hospital, Gloucester, Gloucs, United Kingdom
St Albans City Hospital, St Albans, Hertfordshire, United Kingdom
Queen Elizabeth II Hospital, Welwyn Garden City, Hertfordshire, United Kingdom
Medway Maritime Hospital, Gillingham, Kent, United Kingdom
Princess Royal University Hospital, Orpington, Kent, United Kingdom
Tunbridge Wells Hospital, Tunbridge Wells, Kent, United Kingdom
Grantham and District Hospital, Grantham, Lincolnshire, United Kingdom
University Hospital, Lewisham, Lewisham, London, United Kingdom
Queen Elizabeth Hospital, Woolwich, London, United Kingdom
Ealing Hospital, Southall, Middlesex, United Kingdom
Royal Victoria Infirmary, Newcastle, Newcastle-Upon-Tyne, United Kingdom
Harrogate District Hospital, Harrogate, North Yorkshire, United Kingdom
Belfast City Hospital, Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
Dumfries & Galloway Royal Infirmary, Dumfries, Scotland, United Kingdom
Ninewells Hospital, Dundee, Scotland, United Kingdom
Princess Royal Hospital, Telford, Shropshire, United Kingdom
Weston General Hospital, Avon, Weston-Super-Mare, Somerset, United Kingdom
Barnsley District General Hospital, Barnsley, South Yorkshire, United Kingdom
Rotherham District General Hospital, Rotherham, South Yorkshire, United Kingdom
Ashford and St Peter's Hospitals, Chertsey, Surrey, United Kingdom
Kingston Hospital, Kingston Upon Thames, Surrey, United Kingdom
East Surrey Hospital, Redhill, Surrey, United Kingdom
Bronglais District General Hospital, Aberystwyth, Wales, United Kingdom
Withybush General Hospital, Haverfordwest, Wales, United Kingdom
North Wales CTC, Glan Clwyd Hospital, Rhyl, Wales, United Kingdom
Singleton Hospital, Swansea, Wales, United Kingdom
Neath Port Talbot Hospital, Port Talbot, West Glamorgan, United Kingdom
Tameside General Hospital, Ashton-Under-Lyne, , United Kingdom
Ysbyty Gwynedd, Bangor, , United Kingdom
Royal United Hospital, Bath, , United Kingdom
Queen Elizabeth Hospital, Birmingham, , United Kingdom
Royal Bolton Hospital, Bolton, , United Kingdom
Royal Bournemouth General Hospital, Bournemouth, , United Kingdom
Bristol Royal Infirmary, Bristol, , United Kingdom
Southmead Hospital, Bristol, , United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
East Kent Hospitals, Canterbury, , United Kingdom
University Hospital Of Wales, Cardiff, , United Kingdom
Castle Hill Hospital, Cottingham, , United Kingdom
University Hospital Coventry, Coventry, , United Kingdom
Leighton Hospital, Crewe, , United Kingdom
Darent Valley Hospital, Dartford, , United Kingdom
Royal Derby Hospital, Derby, , United Kingdom
Royal Devon and Exeter Hospital, Exeter, , United Kingdom
Frimley Park Hospital, Frimley, , United Kingdom
Western Infirmary, Glasgow, , United Kingdom
Royal Surrey County Hospital, Guildford, , United Kingdom
Hereford County Hospital, Hereford, , United Kingdom
Huddersfield Royal Infirmary, Huddersfield, , United Kingdom
Ipswich Hospital, Ipswich, , United Kingdom
Leeds General Infirmary/ St James' University Hospital, Leeds, , United Kingdom
University Hospitals of Leicester NHS Trust, Leicester, , United Kingdom
Lincoln County Hospital, Lincoln, , United Kingdom
Royal Liverpool University Hospital, Liverpool, , United Kingdom
Homerton University Hospital, London, , United Kingdom
Charing Cross Hospital, London, , United Kingdom
Northwick Park Hospital, London, , United Kingdom
St Bartholomew's Hospital, London, , United Kingdom
Luton and Dunstable Hospital, Luton, , United Kingdom
Macclesfield District General Hospital, Macclesfield, , United Kingdom
Maidstone Hospital, Maidstone, , United Kingdom
Hillingdon Hospital, Middlesex, , United Kingdom
Milton Keynes General Hospital, Milton Keynes, , United Kingdom
Norfolk and Norwich University Hospital, Norwich, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Dorset County Hospital, Poole, , United Kingdom
Queen's Hospital,, Romford, , United Kingdom
Salford Royal Hospital, Salford, , United Kingdom
Salisbury District Hospital, Salisbury, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Staffordshire General Hospital, Stafford, , United Kingdom
Stepping Hill Hospital, Stockport, , United Kingdom
University Hospital of North Tees, Stockton-on-Tees, , United Kingdom
Musgrove Park Hospital, Taunton, , United Kingdom
St George's Hospital,, Tooting, , United Kingdom
Torbay District General Hospital, Torquay, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
Mid Yorkshire Hospitals, Wakefield, , United Kingdom
Warwick Hospital, Warwick, , United Kingdom
Royal Albert Edward Infirmary, Wigan, , United Kingdom
Worthing Hospital, Worthing, , United Kingdom
Name: Ian Smith, Professor
Affiliation: Royal Marsden NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR