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Breast CancerPhase 3TACT2NCT00301925

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

A Phase 3 study testing pegfilgrastim, capecitabine and cyclophosphamide in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 152 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Breast Cancer
What is being tested?
pegfilgrastim, capecitabine and cyclophosphamide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,400 participants
Where
152 sitesUnited Kingdom
Study dates
16 Dec 2005to Sep 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

152 sites in 1 country.

152 sites in 1 country

United Kingdom152 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Bronglais District General Hospital

    Aberystwyth, Wales, SY23 1ER

  • William Harvey Hospital

    Ashford-Kent, England, TN24 0LZ

  • Wansbeck General Hospital

    Ashington, England, NE63 9JJ

  • Tameside General Hospital

    Ashton-under-Lyne, England, OL6 9RW

  • Ayr Hospital

    Ayr, Scotland, KA6 6DX

  • Ysbyty Gwynedd

    Bangor, Wales, LL57 2PW

  • Barnet General Hospital

    Barnet, Hertfordshire, EN5 3DJ

  • North Devon District Hospital

    Barnstaple, England, EX31 4JB

  • Furness General Hospital

    Barrow in Furness, England, LA14 4LF

  • Basildon University Hospital

    Basildon, England, SS16 5NL

  • Basingstoke and North Hampshire NHS Foundation Trust

    Basingstoke, England, RG24 9NA

  • Belfast City Hospital Trust Incorporating Belvoir Park Hospital

    Belfast, Northern Ireland, BT8 8JR

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

    Belfast, Northern Ireland, BT9 7AB

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Birmingham, England, B15 2TH

  • City Hospital - Birmingham

    Birmingham, England, B18 7QH

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

  • Royal Blackburn Hospital

    Blackburn, England, BB2 3HH

  • Blackpool Victoria Hospital

    Blackpool, England, FY3 8NR

  • Royal Bolton Hospital

    Bolton, Lancashire, England, BL4 0JR

  • Bradford Royal Infirmary

    Bradford, England, BD9 6RJ

  • Princess of Wales Hospital

    Bridgend, Wales, CF31 1JP

  • Sussex Cancer Centre at Royal Sussex County Hospital

    Brighton, England, BN2 5BF

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Broomfield Hospital

    Broomefield, England, CM1 7ET

  • Burnley General Hospital

    Burnley, England, BB10 2PQ

  • Queen's Hospital

    Burton-on-Trent, England, DE13 0RB

  • West Suffolk Hospital

    Bury St Edmunds, England, IP33 2QZ

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

  • Kent and Canterbury Hospital

    Canterbury, England, CT2 3NG

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Halton Hospital

    Cheshire, England, WA7 2DA

  • Chesterfield Royal Hospital

    Chesterfield, England, S44 5BL

  • Saint Richards Hospital

    Chichester, England, P019 4SE

  • Essex County Hospital

    Colchester, England, C03 3NB

  • Walsgrave Hospital

    Coventry, England, CV2 2DX

  • Darent Valley Hospital

    Dartford Kent, England, DA2 8DA

  • Derbyshire Royal Infirmary

    Derby, England, DE1 2QY

  • Dewsbury and District Hospital

    Dewsbury, England, WF13 4HS

  • Doncaster Royal Infirmary

    Doncaster, England, DN2 5LT

  • Russells Hall Hospital

    Dudley, England, DY1 2HQ

  • Dumfries & Galloway Royal Infirmary

    Dumfries, Scotland, DG1 4AP

  • Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • Queen Margaret Hospital - Dunfermline

    Dunfermline, Scotland, KY12 0SU

  • University Hospital of North Durham

    Durham, England, DH1 5TW

  • Hairmyres Hospital

    East Kilbride, Scotland, G75 8RG

  • Eastbourne District General Hospital

    Eastbourne, England, BN21 2UD

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Dr Gray's Hospital

    Elgin, Scotland, IV30 1SN

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Falkirk & District Royal Infirmary

    Falkirk, Scotland, FK1 5QE

  • Queen Elizabeth Hospital

    Gateshead, England, NE9 6SX

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G11 6NT

  • Royal Infirmary - Castle

    Glasgow, Scotland, G4 0SF

  • Gloucestershire Royal Hospital

    Gloucester, England, GL1 3NN

  • Inverclyde Royal Hospital

    Greenock, Scotland, PA16 0XN

  • Diana Princess of Wales Hospital

    Grimsby, England, DN33 2BA

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

    Guildford, England, GU2 7XX

  • UCL Cancer Institute

    Hampstead, London, England, NW3 2QG

  • Withybush General Hospital

    Haverfordwest, Wales, SA61 2PZ

  • Hereford Hospitals NHS Trust

    Hereford, England, HR1 2ER

  • Wycombe General Hospital

    High Wycombe, England

  • Huddersfield Royal Infirmary

    Huddersfield, West Yorks, England, HD3 3EA

  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust

    Hull, England, HU8 9HE

  • King George Hospital

    Ilford, Essex, England, IG3 8YB

  • Raigmore Hospital

    Inverness, Scotland, 1V2 3UJ

  • Ipswich Hospital

    Ipswich, England, IP4 5PD

  • West Middlesex University Hospital

    Isleworth, England, TW7 6AF

  • Airedale General Hospital

    Keighley, England, BD20 6TD

  • Kettering General Hosptial

    Kettering, Northants, England, NNI6 8UZ

  • Kidderminster Hospital

    Kidderminster Worcestershire, England, DY11 6RJ

  • Crosshouse Hospital

    Kilmarnock, Scotland, KA2 OBE

  • Queen Elizabeth Hospital

    Kings Lynn, England, PE30 4ET

  • Royal Albert Edward Infirmary

    Lancanshire, England, WN1 2NN

  • Royal Lancaster Infirmary

    Lancaster, England, LA1 4RP

  • Cookridge Hospital

    Leeds, England, LS16 6QB

  • National Cancer Research Network

    Leeds, England, LS2 9LN

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

    Leeds, England, LS9 7TF

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Royal Glamorgan Hospital

    Lhantrisant, Wales, CF72 8XR

  • Royal Liverpool University Hospital

    Liverpool, England, L7 8XP

  • Aintree University Hospital

    Liverpool, England, L9 7AL

  • St. John's Hospital

    Livingston, Scotland, EH54 6PP

  • Barts and the London School of Medicine

    London, England, EC1M 6BQ

  • Whittington Hospital

    London, England, N19 5NF

  • University College Hospital

    London, England, NW1 2BU

  • Guy's Hospital

    London, England, SE1 9RT

  • King's College Hospital

    London, England, SE5 9RS

  • St. George's Hospital

    London, England, SW17 0QT

  • St. Mary's Hospital

    London, England, W2 1NY

  • Charing Cross Hospital

    London, England, W6 8RF

  • Altnagelvin Area Hospital

    Londonderry, Northern Ireland, BT47 1SB

  • Macclesfield District General Hospital

    Macclesfield, England, SK10 3BL

  • Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Christie Hospital

    Manchester, England, M20 4BX

  • Withington Hospital

    Manchester, England, M20 8LR

  • North Manchester General Hospital - Penine Actute Hospitals Trust

    Manchester, England, M8 6RB

  • Queen Elizabeth The Queen Mother Hospital

    Margate, England, CT9 4AN

  • Clatterbridge Centre for Oncology

    Merseyside, England, CH63 4JY

  • Prince Charles Hospital

    Mid Glamorgan, Wales, CF47 9DT

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • St. Mary's Hospital

    Newport, England, PO30 5TG

  • Royal Gwent Hospital

    Newport Gwent, Wales, NP9 2UB

  • James Paget Hospital

    Norfolk, England, NR31 6LA

  • North Tyneside Hospital

    North Shields, England, NE29 8NH

  • Friarage Hospital

    North Yorks, England, DL6 1JG

  • Northampton General Hospital NHS Trust

    Northampton, England, NN6 8BJ

  • Norfolk and Norwich University Hospital

    Norwich, England, NR4 7UY

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • King's Mills Hospital

    Nottinghamshire, England, NG17 4JL

  • George Eliot Hospital

    Nuneaton, England, CV10 7DJ

  • Royal Oldham Hospital

    Oldham, England, OL1 2JH

  • Radcliffe Infirmary NHS Trust

    Oxford, England, OX2 6HE

  • Churchill Hospital

    Oxford, England, OX3 7LJ

  • Peterborough Hospitals Trust

    Peterborough, England, PE3 6DA

  • Pontefract General Infirmary

    Pontefract West Yorkshire, England, WF8 1PL

  • Whiston Hospital

    Prescot Merseyside, England, L35 5DR

  • Royal Preston Hospital

    Preston, England, PR2 4QF

  • Alexandra Healthcare NHS

    Redditch, Worcestershire, England, B98 7UB

  • Glan Clwyd Hospital

    Rhyl, Denbighshire, Wales, LL 18 5UJ

  • Oldchurch Hospital

    Romford, England, RM7 OBE

  • Conquest Hospital

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

  • Salisbury District Hospital

    Salisbury, England, SP2 8BJ

  • Scarborough General Hospital

    Scarborough, Scotland, YO12 6QL

  • Scunthorpe General Hospital

    Scunthorpe, England, DN15 7BH

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Royal Shrewsbury Hospital

    Shrewsbury, England, SY3 8XQ

  • Solihull Hospital

    Solihull, England, B91 2JL

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Southport and Formby District General Hospital

    Southport, England, PR8 6PN

  • Stepping Hill Hospital

    Stockport, England, SK2 7JE

  • University Hospital of North Staffordshire

    Stoke-on-Trent, England, ST4 7LN

  • Sunderland Royal Hospital

    Sunderland, England, SR4 7TP

  • Great Western Hospital

    Swindon, England, SN3 6BB

  • Taunton and Somerset Hospital

    Taunton, England, TA1 5DA

  • Torbay Hospital

    Torquay, England, TQ2 7AA

  • Royal Cornwall Hospital

    Truro, Cornwall, England, TR1 3LJ

  • Pinderfields General Hospital

    Wakefield, Scotland, WF1 4DG

  • Walsall Manor Hospital

    Walsall, England, WS2 9PS

  • Warrington Hospital NHS Trust

    Warrington, England, WA5 1QG

  • South Warwickshire Hospital

    Warwick, Warwickshire, England, CV34 5BJ

  • Sandwell General Hospital

    West Bromwich, England, B71 4HJ

  • Southend University Hospital NHS Foundation Trust

    Westcliff-on-Sea, England, SS0 0RY

  • Weston General Hospital

    Weston-super-Mare, England, BS23 4TQ

  • Royal Hampshire County Hospital

    Winchester, England, SO22 5DG

  • Wishaw General Hospital

    Wishaw, Scotland, ML2 0DP

  • New Cross Hospital

    Wolverhampton, England, WV10 0QP

  • Worcester Royal Hospital

    Worcester, England, WR5 1DD

  • Wrexham Maelor Hospital

    Wrexham, Wales, LL13 7NT

  • Yeovil District Hospital

    Yeovil - Somerset, England, BA21 4AT

Other trials in United Kingdom

About this study

Official title: Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2)

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.

Read the 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.

Conditions
Breast Cancer
Being tested
pegfilgrastim, capecitabine, cyclophosphamide, epirubicin hydrochloride, fluorouracil
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, male breast cancer
Medical subject headings
Breast Neoplasms, Breast Neoplasms, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00301925
Study groupRoleWhat they receive
Epi-CMFActive comparatorNot described
Receives: Drug: cyclophosphamide; Drug: epirubicin hydrochloride; Drug: fluorouracil; Drug: methotrexate; Procedure: adjuvant therapy
Accelerated Epi-CMFExperimentalNot described
Receives: Biological: pegfilgrastim; Drug: cyclophosphamide; Drug: epirubicin hydrochloride; Drug: fluorouracil; Drug: methotrexate; Procedure: adjuvant therapy
Epi-CapecitabineExperimentalNot described
Receives: Drug: capecitabine; Drug: epirubicin hydrochloride; Procedure: adjuvant therapy
Accelerated Epi-CapecitabineExperimentalNot described
Receives: Biological: pegfilgrastim; Drug: capecitabine; Drug: epirubicin hydrochloride; Procedure: adjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival (DFS) at 5 years

Secondary outcomes (5)

  1. Overall survival at 5 years

  2. Distant DFS at 5 years

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

  4. Detailed toxicity

  5. Quality of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2006 (estimated)
  2. Study start16 Dec 2005
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Enrolment
4,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00301925
Sponsor's protocol ID
CDR0000463447
Other IDs
ICR-TACT2, EU-205114, EUDRACT-2004-000066-13, MREC-04/MRE00/88, ISRCTN68068041
Acronym
TACT2
Status last verified
Aug 2018
First submitted
9 Mar 2006
Last updated
8 Aug 2018
Results posted
No

Publications

  • 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.

    PubMed 37926100

  • 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.

    PubMed 34037241

  • 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.

    PubMed 28600210

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pegfilgrastim, capecitabine and cyclophosphamide in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 152 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) at 5 years. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00301925, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.

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