Combination Chemotherapy in Treating Women With Resected Breast Cancer

NCT00033683 | Unknown Phase 2

• 3 other identifiers: CDR0000069311ICR-TACTEU-20109
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 69

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known which combination chemotherapy regimen is more effective in treating resected stage I or stage II breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating women who have resected stage I or stage II breast cancer.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer

Interventions

CMF regimen DRUG

cyclophosphamide DRUG

docetaxel DRUG

epirubicin hydrochloride DRUG

fluorouracil DRUG

methotrexate DRUG

tamoxifen citrate DRUG

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed completely resected, invasive breast cancer for which adjuvant chemotherapy is indicated * No clinical or radiological evidence of locoregional or metastatic disease * No locally advanced tumors at diagnosis, indicated by any of the following: * Fixed tumors * Peau d'orange skin changes * Skin ulceration * Inflammatory changes (T4 or T3b, N2 disease) * No male breast cancer * No prior invasive breast cancer or bilateral breast cancer * Prior ductal carcinoma in situ or lobular carcinoma in situ is allowed * Must begin study chemotherapy within 8 weeks after definitive surgery * Hormone receptor status: * Estrogen receptor and progesterone receptor status known PATIENT CHARACTERISTICS: Age: * Over 18 Sex: * Female Menopausal status: * Not specified Performance status: * WHO 0-1 Life expectancy: * At least 2 years Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin normal * AST no greater than 1.5 times normal * Alkaline phosphatase no greater than 1.5 times normal Renal: * Creatinine no greater than 1.5 times normal Cardiovascular: * No myocardial infarction within the past 6 months * No congestive heart failure Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other invasive malignancy within the past 10 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix * No other serious medical illness that would limit life expectancy * No psychiatric condition that would preclude informed consent * No active uncontrolled bacterial, viral, or fungal infection PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy Chemotherapy: * See Disease Characteristics * No prior cytotoxic chemotherapy Endocrine therapy: * No concurrent hormonal therapy (e.g., tamoxifen) during study chemotherapy * No concurrent hormone replacement therapy Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics Other: * At least 4 weeks since any prior unlicensed drugs * No other concurrent experimental drugs

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 (69)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

North Devon District Hospital

Barnstaple, England, EX31 4JB, United Kingdom

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

Queen Elizabeth Hospital at University of Birmingham

Birmingham, England, B15 2TH, United Kingdom

Location

City Hospital - Birmingham

Birmingham, England, B18 7QH, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, England, FY3 8NR, United Kingdom

Location

Pilgrim Hospital

Boston, England, PE21 9QT, United Kingdom

Location

Bradford Hospitals NHS Trust

Bradford, England, BD9 6RJ, United Kingdom

Location

Royal Sussex County Hospital

Brighton, England, BN2 5BF, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

West Suffolk Hospital

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

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Broomfield Hospital

Chelmsford, Essex, England, CM1 5ET, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Essex County Hospital

Colchester, England, C03 3NB, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, 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 5XX, United Kingdom

Location

Royal Free and University College Medical School

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

Location

Huddersfield Royal Infirmary

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

Location

Princess Royal Hospital

Hull, England, HU8 9HE, United Kingdom

Location

Ipswich Hospital NHS Trust

Ipswich, England, IP4 5PD, United Kingdom

Location

Queen Elizabeth Hospital

Kings Lynn, England, PE30 4ET, United Kingdom

Location

Cookridge Hospital at Leeds Teaching Hospital NHS Trust

Leeds, England, LS16 6QB, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Guy's Hospital

London, England, SE1 9RT, United Kingdom

Location

St. Georges Hospital Medical School

London, England, SW17 ORE, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Meyerstein Institute of Oncology at University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, CH63 4JY, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

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

Location

Northampton General Hospital NHS Trust

Northampton, England, NN6 8BJ, United Kingdom

Location

Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

Location

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth Hants, England, PO3 6AD, United Kingdom

Location

Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, RG1 5AN, United Kingdom

Location

Alexandra Healthcare NHS

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

Location

Oldchurch Hospital

Romford, England, RM7 OBE, 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

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

North Staffs Royal Infirmary

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

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Taunton and Somerset Hospital

Taunton Somerset, England, TA1 5DA, United Kingdom

Location

Torbay Hospital

Torquay Devon, England, TQ2 7AA, United Kingdom

Location

Southend NHS Trust Hospital

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

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Belfast City Hospital Trust Incorporating Belvoir Park Hospital

Belfast, Northern Ireland, BT8 8JR, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Hairmyres Hospital

East Kilbride, Scotland, G75 8RG, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Bronglais General Hospital - Ceredigion and Mid Wales NHS trust

Aberystwyth, Wales, SY23 1ER, United Kingdom

Location

Velindre Cancer Center at Velinde Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Glan Clywd District General Hospital

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

Location

Singleton Hospital

Swansea, Wales, SA 2 8QA, United Kingdom

Location

Related Publications (2)

• Hopwood P, Ellis P, Barrett-Lee P, et al.: Impact on quality of life (QL) during chemotherapy (CT) of FEC-T compared to FEC or E-CMF: results from the UK NCRI taxotere as adjuvant chemotherapy trial (TACT). [Abstract] J Clin Oncol 23 (Suppl 16): A-661, 43s, 2005.

  RESULT

• Kilburn LS, Aresu M, Banerji J, Barrett-Lee P, Ellis P, Bliss JM. Can routine data be used to support cancer clinical trials? A historical baseline on which to build: retrospective linkage of data from the TACT (CRUK 01/001) breast cancer trial and the National Cancer Data Repository. Trials. 2017 Nov 23;18(1):561. doi: 10.1186/s13063-017-2308-6.

  PMID: 29179731 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CMF regimen; Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Methotrexate; Tamoxifen; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Jane Banerji

  Institute of Cancer Research, United Kingdom

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: January 27, 2003
• Study Start: February 1, 2001
• Last Updated: February 9, 2009

Record last verified: 2005-06

Locations

GB (68); BE (1)