The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery
Official Title: Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2)
Study ID: NCT00301925
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early stage breast cancer that has been removed by surgery. PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens to compare how well they work in treating patients with early stage breast cancer that has been removed by surgery.
Detailed Description: OBJECTIVES: Primary * Compare the disease-free survival (DFS) of patients with completely resected early stage breast cancer receiving 1 of 2 different schedules of adjuvant chemotherapy comprising epirubicin, cyclophosphamide, methotrexate, and fluorouracil versus 1 of 2 different schedules of adjuvant chemotherapy comprising epirubicin and capecitabine. Secondary * Compare overall survival (OS) and distant disease-free survival (DFS). * Compare the tolerability (including serious adverse events \[SAE\], dose-intensity, and toxicity) of these regimens. * Determine the detailed toxicity of these regimens. * Determine the quality of life of a subset of these patients. OUTLINE: This is a multi-center, randomized study. Patients are stratified according to participating center, nodal status (N0 vs N1-3 vs N≥ 4), age (≤ 50 years vs \> 50 years), and estrogen receptor (ER) status (negative vs positive). Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive epirubicin on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive cyclophosphamide orally once daily on days 1-14 or IV on days 1 and 8 and methotrexate and fluorouracil on days 1 and 8. Treatment repeats every 28 days for 4 courses. * Arm II: Patients receive epirubicin on day 1 and pegfilgrastim on day 2. Treatment repeats every 2 weeks for 4 courses. Patients then receive cyclophosphamide, methotrexate and fluorouracil as in arm I. * Arm III: Patients receive epirubicin as in arm I. Patients then receive oral capecitabine twice daily on days 1-14. Treatment with capecitabine repeats every 3 weeks for 4 courses. * Arm IV: Patients receive epirubicin and pegfilgrastim as in arm II. Patients then receive capecitabine as in arm III. In all arms, treatment continues in the absence of unacceptable toxicity. Beginning 3-6 months later, all patients may undergo radiotherapy at the discretion of the principal investigator. Patients with ER- and/or progesterone receptor-positive disease then receive tamoxifen citrate or an aromatase inhibitor for up to 5 years. Quality of life is assessed in a cohort of 1,000 patients in week 6, week 8 or 12, and week 20 or 24 during treatment and then at 12 and 24 months after randomization. After completion of study therapy, patients are followed every 6 months for 2 years and then annually for at least 10 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK. PROJECTED ACCRUAL: A total of 4,400 patients will be accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
William Harvey Hospital, Ashford-Kent, England, United Kingdom
Wansbeck General Hospital, Ashington, England, United Kingdom
Tameside General Hospital, Ashton-Under-Lyne, England, United Kingdom
North Devon District Hospital, Barnstaple, England, United Kingdom
Furness General Hospital, Barrow in Furness, England, United Kingdom
Basildon University Hospital, Basildon, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust, Basingstoke, England, United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham, England, United Kingdom
City Hospital - Birmingham, Birmingham, England, United Kingdom
Birmingham Heartlands Hospital, Birmingham, England, United Kingdom
Royal Blackburn Hospital, Blackburn, England, United Kingdom
Blackpool Victoria Hospital, Blackpool, England, United Kingdom
Royal Bolton Hospital, Bolton, Lancashire, England, United Kingdom
Bradford Royal Infirmary, Bradford, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital, Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom
Broomfield Hospital, Broomefield, England, United Kingdom
Burnley General Hospital, Burnley, England, United Kingdom
Queen's Hospital, Burton-upon-Trent, England, United Kingdom
West Suffolk Hospital, Bury St. Edmunds, England, United Kingdom
Addenbrooke's Hospital, Cambridge, England, United Kingdom
Kent and Canterbury Hospital, Canterbury, England, United Kingdom
Cheltenham General Hospital, Cheltenham, England, United Kingdom
Halton Hospital, Cheshire, England, United Kingdom
Chesterfield Royal Hospital, Chesterfield, England, United Kingdom
Saint Richards Hospital, Chichester, England, United Kingdom
Essex County Hospital, Colchester, England, United Kingdom
Walsgrave Hospital, Coventry, England, United Kingdom
Darent Valley Hospital, Dartford Kent, England, United Kingdom
Derbyshire Royal Infirmary, Derby, England, United Kingdom
Dewsbury and District Hospital, Dewsbury, England, United Kingdom
Doncaster Royal Infirmary, Doncaster, England, United Kingdom
Russells Hall Hospital, Dudley, England, United Kingdom
University Hospital of North Durham, Durham, England, United Kingdom
Eastbourne District General Hospital, Eastbourne, England, United Kingdom
Royal Devon and Exeter Hospital, Exeter, England, United Kingdom
Queen Elizabeth Hospital, Gateshead, England, United Kingdom
Gloucestershire Royal Hospital, Gloucester, England, United Kingdom
Diana Princess of Wales Hospital, Grimsby, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital, Guildford, England, United Kingdom
UCL Cancer Institute, Hampstead, London, England, United Kingdom
Hereford Hospitals NHS Trust, Hereford, England, United Kingdom
Wycombe General Hospital, High Wycombe, England, United Kingdom
Huddersfield Royal Infirmary, Huddersfield, West Yorks, England, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust, Hull, England, United Kingdom
King George Hospital, Ilford, Essex, England, United Kingdom
Ipswich Hospital, Ipswich, England, United Kingdom
West Middlesex University Hospital, Isleworth, England, United Kingdom
Airedale General Hospital, Keighley, England, United Kingdom
Kettering General Hosptial, Kettering, Northants, England, United Kingdom
Kidderminster Hospital, Kidderminster Worcestershire, England, United Kingdom
Queen Elizabeth Hospital, King's Lynn, England, United Kingdom
Royal Albert Edward Infirmary, Lancanshire, England, United Kingdom
Royal Lancaster Infirmary, Lancaster, England, United Kingdom
Cookridge Hospital, Leeds, England, United Kingdom
National Cancer Research Network, Leeds, England, United Kingdom
Cancer Research UK Clinical Centre at St. James's University Hospital, Leeds, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom
Royal Liverpool University Hospital, Liverpool, England, United Kingdom
Aintree University Hospital, Liverpool, England, United Kingdom
Barts and the London School of Medicine, London, England, United Kingdom
Whittington Hospital, London, England, United Kingdom
University College Hospital, London, England, United Kingdom
Guy's Hospital, London, England, United Kingdom
King's College Hospital, London, England, United Kingdom
St. George's Hospital, London, England, United Kingdom
St. Mary's Hospital, London, England, United Kingdom
Charing Cross Hospital, London, England, United Kingdom
Macclesfield District General Hospital, Macclesfield, England, United Kingdom
Maidstone Hospital, Maidstone, England, United Kingdom
Christie Hospital, Manchester, England, United Kingdom
Withington Hospital, Manchester, England, United Kingdom
North Manchester General Hospital - Penine Actute Hospitals Trust, Manchester, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital, Margate, England, United Kingdom
Clatterbridge Centre for Oncology, Merseyside, England, United Kingdom
James Cook University Hospital, Middlesbrough, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital, Newcastle-Upon-Tyne, England, United Kingdom
St. Mary's Hospital, Newport, England, United Kingdom
James Paget Hospital, Norfolk, England, United Kingdom
North Tyneside Hospital, North Shields, England, United Kingdom
Friarage Hospital, North Yorkshire, England, United Kingdom
Northampton General Hospital NHS Trust, Northampton, England, United Kingdom
Norfolk and Norwich University Hospital, Norwich, England, United Kingdom
King's Mills Hospital, Nottinghamshire, England, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom
George Eliot Hospital, Nuneaton, England, United Kingdom
Royal Oldham Hospital, Oldham, England, United Kingdom
Radcliffe Infirmary NHS Trust, Oxford, England, United Kingdom
Churchill Hospital, Oxford, England, United Kingdom
Peterborough Hospitals Trust, Peterborough, England, United Kingdom
Pontefract General Infirmary, Pontefract West Yorkshire, England, United Kingdom
Whiston Hospital, Prescot Merseyside, England, United Kingdom
Royal Preston Hospital, Preston, England, United Kingdom
Alexandra Healthcare NHS, Redditch, Worcestershire, England, United Kingdom
Oldchurch Hospital, Romford, England, United Kingdom
Conquest Hospital, Saint Leonards-on-Sea, England, United Kingdom
Salisbury District Hospital, Salisbury, England, United Kingdom
Scunthorpe General Hospital, Scunthorpe, England, United Kingdom
Cancer Research Centre at Weston Park Hospital, Sheffield, England, United Kingdom
Royal Shrewsbury Hospital, Shrewsbury, England, United Kingdom
Solihull Hospital, Solihull, England, United Kingdom
Southampton General Hospital, Southampton, England, United Kingdom
Southport and Formby District General Hospital, Southport, England, United Kingdom
Stepping Hill Hospital, Stockport, England, United Kingdom
University Hospital of North Staffordshire, Stoke-On-Trent, England, United Kingdom
Sunderland Royal Hospital, Sunderland, England, United Kingdom
Great Western Hospital, Swindon, England, United Kingdom
Taunton and Somerset Hospital, Taunton, England, United Kingdom
Torbay Hospital, Torquay, England, United Kingdom
Royal Cornwall Hospital, Truro, Cornwall, England, United Kingdom
Walsall Manor Hospital, Walsall, England, United Kingdom
Warrington Hospital NHS Trust, Warrington, England, United Kingdom
South Warwickshire Hospital, Warwick, Warwickshire, England, United Kingdom
Sandwell General Hospital, West Bromwich, England, United Kingdom
Southend University Hospital NHS Foundation Trust, Westcliff-On-Sea, England, United Kingdom
Weston General Hospital, Weston-super-Mare, 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 - Somerset, England, United Kingdom
Belfast City Hospital Trust Incorporating Belvoir Park Hospital, Belfast, Northern Ireland, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast, Belfast, Northern Ireland, United Kingdom
Altnagelvin Area Hospital, Londonderry, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
Ayr Hospital, Ayr, Scotland, United Kingdom
Dumfries & Galloway Royal Infirmary, Dumfries, Scotland, United Kingdom
Ninewells Hospital, Dundee, Scotland, United Kingdom
Queen Margaret Hospital - Dunfermline, Dunfermline, Scotland, United Kingdom
Hairmyres Hospital, East Kilbride, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital, Edinburgh, Scotland, United Kingdom
Dr Gray's Hospital, Elgin, Scotland, United Kingdom
Falkirk & District Royal Infirmary, Falkirk, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom
Royal Infirmary - Castle, Glasgow, Scotland, United Kingdom
Inverclyde Royal Hospital, Greenock, Scotland, United Kingdom
Raigmore Hospital, Inverness, Scotland, United Kingdom
Crosshouse Hospital, Kilmarnock, Scotland, United Kingdom
St. John's Hospital, Livingston, Scotland, United Kingdom
Scarborough General Hospital, Scarborough, Scotland, United Kingdom
Pinderfields General Hospital, Wakefield, Scotland, United Kingdom
Wishaw General Hospital, Wishaw, Scotland, United Kingdom
Bronglais District General Hospital, Aberystwyth, Wales, United Kingdom
Ysbyty Gwynedd, Bangor, Wales, United Kingdom
Princess of Wales Hospital, Bridgend, Wales, United Kingdom
Velindre Cancer Center at Velindre Hospital, Cardiff, Wales, United Kingdom
Withybush General Hospital, Haverfordwest, Wales, United Kingdom
Royal Glamorgan Hospital, Lhantrisant, Wales, United Kingdom
Prince Charles Hospital, Mid Glamorgan, Wales, United Kingdom
Royal Gwent Hospital, Newport Gwent, Wales, United Kingdom
Glan Clwyd Hospital, Rhyl, Denbighshire, Wales, United Kingdom
Wrexham Maelor Hospital, Wrexham, Wales, United Kingdom
Barnet General Hospital, Barnet, Hertfordshire, , United Kingdom
Name: David Cameron, MD
Affiliation: National Cancer Research Network
Role: STUDY_CHAIR