Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery

NCT00301925 | Unknown Phase 3

• 6 other identifiers: CDR0000463447ICR-TACT2EU-205114EUDRACT-2004-000066-13MREC-04/MRE00/88ISRCTN68068041
• Study Type: interventional
• Target: 4,400
• Locations: 1 country
• Sites: 152

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS) at 5 years

Secondary Outcomes (5)

• Overall survival at 5 years

• Distant DFS at 5 years

• Tolerability (including serious adverse events, dose-intensity, and toxicity)

• Detailed toxicity

• Quality of life

Study Arms (4)

Epi-CMF

ACTIVE COMPARATOR

Drug: cyclophosphamide; Drug: epirubicin hydrochloride; Drug: fluorouracil; Drug: methotrexate; Procedure: adjuvant therapy

Accelerated Epi-CMF

EXPERIMENTAL

Biological: pegfilgrastim; Drug: cyclophosphamide; Drug: epirubicin hydrochloride; Drug: fluorouracil; Drug: methotrexate; Procedure: adjuvant therapy

Epi-Capecitabine

EXPERIMENTAL

Drug: capecitabine; Drug: epirubicin hydrochloride; Procedure: adjuvant therapy

Accelerated Epi-Capecitabine

EXPERIMENTAL

Biological: pegfilgrastim; Drug: capecitabine; Drug: epirubicin hydrochloride; Procedure: adjuvant therapy

Interventions

pegfilgrastim BIOLOGICAL

Accelerated Epi-CMF; Accelerated Epi-Capecitabine

capecitabine DRUG

Accelerated Epi-Capecitabine; Epi-Capecitabine

cyclophosphamide DRUG

Accelerated Epi-CMF; Epi-CMF

epirubicin hydrochloride DRUG

Accelerated Epi-CMF; Accelerated Epi-Capecitabine; Epi-CMF; Epi-Capecitabine

fluorouracil DRUG

Accelerated Epi-CMF; Epi-CMF

methotrexate DRUG

Accelerated Epi-CMF; Epi-CMF

adjuvant therapy PROCEDURE

Accelerated Epi-CMF; Accelerated Epi-Capecitabine; Epi-CMF; Epi-Capecitabine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histological diagnosis of invasive breast carcinoma * Cytological proof of malignancy alone is not sufficient * Early stage disease (T0-3, N0-2, M0) without clinical suspicion or evidence of distant metastases on routine staging * No locally advanced breast cancer (T4 and/or N3 disease) * Completely resected disease by breast-conserving surgery with axillary node clearance or modified radical mastectomy within the past 4-8 weeks * Negative surgical margins required, unless either of the following are true: * Deep surgical margins after full thickness resection * Noninvasive cancer at surgical margins for which a mastectomy is planned after completion of study chemotherapy * No contraindication for or refusal of postoperative radiotherapy in patients who underwent prior breast-conserving surgery * Definite indication for adjuvant chemotherapy * No prior or current invasive breast cancer or bilateral breast cancer * Prior surgically-treated ductal carcinoma in situ or lobular carcinoma in situ allowed * Hormone receptor status: * Estrogen receptor- and/or progesterone receptor-positive or -negative tumor PATIENT CHARACTERISTICS: * Sex: male or female * Menopausal status: premenopausal or postmenopausal * No previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or any cancer from which the patient has been disease-free for 10 years and for which treatment consisted solely of resection * ECOG status 0 or 1 * Hemoglobin \> 9 g/dL * WBC \> 3,000/mm³ * Platelet count \> 10,000/mm³ * Bilirubin normal (unless due to known Gilbert's disease) * AST and ALT ≤ 1.5 times upper limit of normal (ULN) * Albumin normal * Creatinine ≤ 1.5 times ULN * Creatinine clearance \> 50 mL/min * No active, uncontrolled infection * Not pregnant or nursing * Fertile patients must use effective contraception * No concurrent medical, psychiatric, or geographic problems that might prevent completion of treatment or follow-up * Available for a minimum of 5 years' follow-up * No known serious viral infection such as active hepatitis B, hepatitis C, or HIV * No significant cardiac disease, such as impaired left ventricular function or active angina requiring regular anti-anginal medication and/or resulting in restricted physical activity * No history of significant renal impairment or disease PRIOR CONCURRENT THERAPY: * No simultaneous participation in the active intervention phase of another treatment trial * Not being approached or recruited for another trial within 2 months of study entry * No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except for either of the following: * Previous radiotherapy for basal cell carcinoma * Previous preoperative endocrine therapy, provided there was no evidence of progression during this therapy, it lasted for less than 6 weeks in duration, and it was stopped at least one month prior to trial entry * Concurrent luteinizing hormone-releasing hormone analog therapy allowed for premenopausal patients * More than 4 weeks since prior hormone replacement therapy (HRT) or pre-operative endocrine therapy * No prior breast conserving surgery if there is a contradiction for or refusal of postoperative radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (152)

William Harvey Hospital

Ashford-Kent, England, TN24 0LZ, United Kingdom

Location

Wansbeck General Hospital

Ashington, England, NE63 9JJ, United Kingdom

Location

Tameside General Hospital

Ashton-under-Lyne, England, OL6 9RW, United Kingdom

Location

North Devon District Hospital

Barnstaple, England, EX31 4JB, United Kingdom

Location

Furness General Hospital

Barrow in Furness, England, LA14 4LF, United Kingdom

Location

Basildon University Hospital

Basildon, England, SS16 5NL, United Kingdom

Location

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

Location

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

Location

City Hospital - Birmingham

Birmingham, England, B18 7QH, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

Royal Blackburn Hospital

Blackburn, England, BB2 3HH, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, England, FY3 8NR, United Kingdom

Location

Royal Bolton Hospital

Bolton, Lancashire, England, BL4 0JR, United Kingdom

Location

Bradford Royal Infirmary

Bradford, England, BD9 6RJ, United Kingdom

Location

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BF, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Broomfield Hospital

Broomefield, England, CM1 7ET, United Kingdom

Location

Burnley General Hospital

Burnley, England, BB10 2PQ, United Kingdom

Location

Queen's Hospital

Burton-on-Trent, England, DE13 0RB, United Kingdom

Location

West Suffolk Hospital

Bury St Edmunds, England, IP33 2QZ, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT2 3NG, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Halton Hospital

Cheshire, England, WA7 2DA, United Kingdom

Location

Chesterfield Royal Hospital

Chesterfield, England, S44 5BL, United Kingdom

Location

Saint Richards Hospital

Chichester, England, P019 4SE, United Kingdom

Location

Essex County Hospital

Colchester, England, C03 3NB, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Darent Valley Hospital

Dartford Kent, England, DA2 8DA, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Dewsbury and District Hospital

Dewsbury, England, WF13 4HS, United Kingdom

Location

Doncaster Royal Infirmary

Doncaster, England, DN2 5LT, United Kingdom

Location

Russells Hall Hospital

Dudley, England, DY1 2HQ, United Kingdom

Location

University Hospital of North Durham

Durham, England, DH1 5TW, United Kingdom

Location

Eastbourne District General Hospital

Eastbourne, England, BN21 2UD, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Queen Elizabeth Hospital

Gateshead, England, NE9 6SX, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

Diana Princess of Wales Hospital

Grimsby, England, DN33 2BA, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

UCL Cancer Institute

Hampstead, London, England, NW3 2QG, United Kingdom

Location

Hereford Hospitals NHS Trust

Hereford, England, HR1 2ER, United Kingdom

Location

Wycombe General Hospital

High Wycombe, England, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

Location

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, HU8 9HE, United Kingdom

Location

King George Hospital

Ilford, Essex, England, IG3 8YB, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

West Middlesex University Hospital

Isleworth, England, TW7 6AF, United Kingdom

Location

Airedale General Hospital

Keighley, England, BD20 6TD, United Kingdom

Location

Kettering General Hosptial

Kettering, Northants, England, NNI6 8UZ, United Kingdom

Location

Kidderminster Hospital

Kidderminster Worcestershire, England, DY11 6RJ, United Kingdom

Location

Queen Elizabeth Hospital

Kings Lynn, England, PE30 4ET, United Kingdom

Location

Royal Albert Edward Infirmary

Lancanshire, England, WN1 2NN, United Kingdom

Location

Royal Lancaster Infirmary

Lancaster, England, LA1 4RP, United Kingdom

Location

Cookridge Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

National Cancer Research Network

Leeds, England, LS2 9LN, United Kingdom

Location

Cancer Research UK Clinical Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L7 8XP, United Kingdom

Location

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

Barts and the London School of Medicine

London, England, EC1M 6BQ, United Kingdom

Location

Whittington Hospital

London, England, N19 5NF, United Kingdom

Location

University College Hospital

London, England, NW1 2BU, United Kingdom

Location

Guy's Hospital

London, England, SE1 9RT, United Kingdom

Location

King's College Hospital

London, England, SE5 9RS, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

St. Mary's Hospital

London, England, W2 1NY, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Macclesfield District General Hospital

Macclesfield, England, SK10 3BL, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Withington Hospital

Manchester, England, M20 8LR, United Kingdom

Location

North Manchester General Hospital - Penine Actute Hospitals Trust

Manchester, England, M8 6RB, United Kingdom

Location

Queen Elizabeth The Queen Mother Hospital

Margate, England, CT9 4AN, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

St. Mary's Hospital

Newport, England, PO30 5TG, United Kingdom

Location

James Paget Hospital

Norfolk, England, NR31 6LA, United Kingdom

Location

North Tyneside Hospital

North Shields, England, NE29 8NH, United Kingdom

Location

Friarage Hospital

North Yorks, England, DL6 1JG, United Kingdom

Location

Northampton General Hospital NHS Trust

Northampton, England, NN6 8BJ, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

King's Mills Hospital

Nottinghamshire, England, NG17 4JL, United Kingdom

Location

George Eliot Hospital

Nuneaton, England, CV10 7DJ, United Kingdom

Location

Royal Oldham Hospital

Oldham, England, OL1 2JH, United Kingdom

Location

Radcliffe Infirmary NHS Trust

Oxford, England, OX2 6HE, United Kingdom

Location

Churchill Hospital

Oxford, England, OX3 7LJ, United Kingdom

Location

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

Location

Pontefract General Infirmary

Pontefract West Yorkshire, England, WF8 1PL, United Kingdom

Location

Whiston Hospital

Prescot Merseyside, England, L35 5DR, United Kingdom

Location

Royal Preston Hospital

Preston, England, PR2 4QF, United Kingdom

Location

Alexandra Healthcare NHS

Redditch, Worcestershire, England, B98 7UB, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Conquest Hospital

Saint Leonards-on-Sea, England, TN37 7RD, United Kingdom

Location

Salisbury District Hospital

Salisbury, England, SP2 8BJ, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, England, DN15 7BH, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, England, SY3 8XQ, United Kingdom

Location

Solihull Hospital

Solihull, England, B91 2JL, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Southport and Formby District General Hospital

Southport, England, PR8 6PN, United Kingdom

Location

Stepping Hill Hospital

Stockport, England, SK2 7JE, United Kingdom

Location

University Hospital of North Staffordshire

Stoke-on-Trent, England, ST4 7LN, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, England, SR4 7TP, United Kingdom

Location

Great Western Hospital

Swindon, England, SN3 6BB, United Kingdom

Location

Taunton and Somerset Hospital

Taunton, England, TA1 5DA, United Kingdom

Location

Torbay Hospital

Torquay, England, TQ2 7AA, United Kingdom

Location

Royal Cornwall Hospital

Truro, Cornwall, England, TR1 3LJ, United Kingdom

Location

Walsall Manor Hospital

Walsall, England, WS2 9PS, United Kingdom

Location

Warrington Hospital NHS Trust

Warrington, England, WA5 1QG, United Kingdom

Location

South Warwickshire Hospital

Warwick, Warwickshire, England, CV34 5BJ, United Kingdom

Location

Sandwell General Hospital

West Bromwich, England, B71 4HJ, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Weston General Hospital

Weston-super-Mare, England, BS23 4TQ, United Kingdom

Location

Royal Hampshire County Hospital

Winchester, England, SO22 5DG, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Worcester Royal Hospital

Worcester, England, WR5 1DD, United Kingdom

Location

Yeovil District Hospital

Yeovil - Somerset, England, BA21 4AT, United Kingdom

Location

Belfast City Hospital Trust Incorporating Belvoir Park Hospital

Belfast, Northern Ireland, BT8 8JR, United Kingdom

Location

Centre for Cancer Research and Cell Biology at Queen's University Belfast

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Altnagelvin Area Hospital

Londonderry, Northern Ireland, BT47 1SB, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ayr Hospital

Ayr, Scotland, KA6 6DX, United Kingdom

Location

Dumfries & Galloway Royal Infirmary

Dumfries, Scotland, DG1 4AP, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Queen Margaret Hospital - Dunfermline

Dunfermline, Scotland, KY12 0SU, United Kingdom

Location

Hairmyres Hospital

East Kilbride, Scotland, G75 8RG, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Dr Gray's Hospital

Elgin, Scotland, IV30 1SN, United Kingdom

Location

Falkirk & District Royal Infirmary

Falkirk, Scotland, FK1 5QE, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Inverclyde Royal Hospital

Greenock, Scotland, PA16 0XN, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Crosshouse Hospital

Kilmarnock, Scotland, KA2 OBE, United Kingdom

Location

St. John's Hospital

Livingston, Scotland, EH54 6PP, United Kingdom

Location

Scarborough General Hospital

Scarborough, Scotland, YO12 6QL, United Kingdom

Location

Pinderfields General Hospital

Wakefield, Scotland, WF1 4DG, United Kingdom

Location

Wishaw General Hospital

Wishaw, Scotland, ML2 0DP, United Kingdom

Location

Bronglais District General Hospital

Aberystwyth, Wales, SY23 1ER, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

Princess of Wales Hospital

Bridgend, Wales, CF31 1JP, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Withybush General Hospital

Haverfordwest, Wales, SA61 2PZ, United Kingdom

Location

Royal Glamorgan Hospital

Lhantrisant, Wales, CF72 8XR, United Kingdom

Location

Prince Charles Hospital

Mid Glamorgan, Wales, CF47 9DT, United Kingdom

Location

Royal Gwent Hospital

Newport Gwent, Wales, NP9 2UB, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

Wrexham Maelor Hospital

Wrexham, Wales, LL13 7NT, United Kingdom

Location

Barnet General Hospital

Barnet, Hertfordshire, EN5 3DJ, United Kingdom

Location

Related Publications (3)

• Velikova G, Morden JP, Haviland JS, Emery C, Barrett-Lee P, Earl H, Bloomfield D, Brunt AM, Canney P, Coleman R, Verrill M, Wardley A, Bertelli G, Ellis P, Stein R, Bliss JM, Cameron D; TACT2 Trial Management Group. Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer (UK TACT2; CRUK/05/19): quality of life results from a multicentre, phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2023 Dec;24(12):1359-1374. doi: 10.1016/S1470-2045(23)00460-6. Epub 2023 Nov 2.

  PMID: 37926100 DERIVED

• Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

  PMID: 34037241 DERIVED

• Cameron D, Morden JP, Canney P, Velikova G, Coleman R, Bartlett J, Agrawal R, Banerji J, Bertelli G, Bloomfield D, Brunt AM, Earl H, Ellis P, Gaunt C, Gillman A, Hearfield N, Laing R, Murray N, Couper N, Stein RC, Verrill M, Wardley A, Barrett-Lee P, Bliss JM; TACT2 Investigators. Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer in the randomised UK TACT2 trial (CRUK/05/19): a multicentre, phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2017 Jul;18(7):929-945. doi: 10.1016/S1470-2045(17)30404-7. Epub 2017 Jun 7.

  PMID: 28600210 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

pegfilgrastim; Capecitabine; Cyclophosphamide; Epirubicin; Fluorouracil; Methotrexate; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• David Cameron, MD

  National Cancer Research Network

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 13, 2006
• Study Start: December 16, 2005
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

GB (152)