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Breast CancerPhase 2NCT00033683

Combination Chemotherapy in Treating Women With Resected Breast Cancer

A Phase 2 study testing CMF regimen, cyclophosphamide and docetaxel in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 69 sites in 2 countries.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
CMF regimen, cyclophosphamide and docetaxel
Type of treatment
Surgery or procedure
How many people
Not given
Where
69 sitesin 2 countries
Study dates
Feb 2001to not given
Phase
Phase 2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

69 sites in 2 countries.

69 sites in 2 countries

United Kingdom68 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Bronglais General Hospital - Ceredigion and Mid Wales NHS trust

    Aberystwyth, Wales, SY23 1ER

  • North Devon District Hospital

    Barnstaple, England, EX31 4JB

  • Royal United Hospital

    Bath, England, BA1 3NG

  • Belfast City Hospital Trust Incorporating Belvoir Park Hospital

    Belfast, Northern Ireland, BT8 8JR

  • Queen Elizabeth Hospital at University of Birmingham

    Birmingham, England, B15 2TH

  • City Hospital - Birmingham

    Birmingham, England, B18 7QH

  • Blackpool Victoria Hospital

    Blackpool, England, FY3 8NR

  • Pilgrim Hospital

    Boston, England, PE21 9QT

  • Bradford Hospitals NHS Trust

    Bradford, England, BD9 6RJ

  • Royal Sussex County Hospital

    Brighton, England, BN2 5BF

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • West Suffolk Hospital

    Bury St Edmunds, England, IP33 2QZ

  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England, CB2 2QQ

  • Velindre Cancer Center at Velinde Hospital

    Cardiff, Wales, CF14 2TL

  • Broomfield Hospital

    Chelmsford, Essex, England, CM1 5ET

  • Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Essex County Hospital

    Colchester, England, C03 3NB

  • Walsgrave Hospital

    Coventry, England, CV2 2DX

  • Derbyshire Royal Infirmary

    Derby, England, DE1 2QY

  • Ninewells Hospital and Medical School

    Dundee, Scotland, DD1 9SY

  • Hairmyres Hospital

    East Kilbride, Scotland, G75 8RG

  • Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Beatson Oncology Centre

    Glasgow, Scotland, G11 6NT

  • Royal Infirmary - Castle

    Glasgow, Scotland, G4 0SF

  • Diana Princess of Wales Hospital

    Grimsby, England, DN33 2BA

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

    Guildford, England, GU2 5XX

  • Royal Free and University College Medical School

    Hampstead, London, England, NW3 2QG

  • Huddersfield Royal Infirmary

    Huddersfield, West Yorks, England, HD3 3EA

  • Princess Royal Hospital

    Hull, England, HU8 9HE

  • Raigmore Hospital

    Inverness, Scotland, 1V2 3UJ

  • Ipswich Hospital NHS Trust

    Ipswich, England, IP4 5PD

  • Queen Elizabeth Hospital

    Kings Lynn, England, PE30 4ET

  • Cookridge Hospital at Leeds Teaching Hospital NHS Trust

    Leeds, England, LS16 6QB

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

    Leeds, England, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Guy's Hospital

    London, England, SE1 9RT

  • St. Georges Hospital Medical School

    London, England, SW17 ORE

  • Charing Cross Hospital

    London, England, W6 8RF

  • Meyerstein Institute of Oncology at University College of London Hospitals

    London, England, WIT 3AA

  • Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Christie Hospital N.H.S. Trust

    Manchester, England, M20 4BX

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, CH63 4JY

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Northampton General Hospital NHS Trust

    Northampton, England, NN6 8BJ

  • Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Oxford Radcliffe Hospital

    Oxford, England, 0X3 9DU

  • Peterborough Hospitals Trust

    Peterborough, England, PE3 6DA

  • Portsmouth Oncology Centre at Saint Mary's Hospital

    Portsmouth Hants, England, PO3 6AD

  • Royal Preston Hospital

    Preston, England, PR2 9HT

  • Berkshire Cancer Centre at Royal Berkshire Hospital

    Reading, England, RG1 5AN

  • Alexandra Healthcare NHS

    Redditch, Worcestershire, England, B98 7UB

  • Glan Clywd District General Hospital

    Rhyl, Denbighshire, Wales, LL 18 5UJ

  • Oldchurch Hospital

    Romford, England, RM7 OBE

  • Salisbury District Hospital

    Salisbury, England, SP2 8BJ

  • 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

  • Royal South Hants Hospital

    Southampton, England, SO14 0YG

  • North Staffs Royal Infirmary

    Stoke-on-Trent, England, ST4 7LN

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

  • Singleton Hospital

    Swansea, Wales, SA 2 8QA

  • Taunton and Somerset Hospital

    Taunton Somerset, England, TA1 5DA

  • Torbay Hospital

    Torquay Devon, England, TQ2 7AA

  • Southend NHS Trust Hospital

    Westcliff-on-Sea, England, SS0 0RY

  • New Cross Hospital

    Wolverhampton, England, WV10 0QP

Other trials in United Kingdom

Belgium1 site

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

About this study

Official title: A Randomised Trial Of Standard Anthracycline-Based Chemotherapy With Fluorouracil, Epirubicin And Cyclophosphamide (FEC) Or Epirubicin And CMF (Epi-CMF) Versus FEC Followed By Sequential Docetaxel As Adjuvant Treatment For Women With Early Breast Cancer

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.

Read the detailed description

OBJECTIVES:

  • Compare the disease-free and overall survival of women with completely resected stage I or II breast cancer adjuvantly treated with fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil (EPI-CMF) versus FEC followed by sequential docetaxel.
  • Compare the acute toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, estrogen receptor status (positive vs negative), and nodal status. Within 8 weeks after definitive surgery, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients are assigned to 1 of 2 standard adjuvant chemotherapy regimens.
  • Regimen A: Patients receive fluorouracil, epirubicin, and cyclophosphamide (FEC) IV on day 1. Treatment repeats every 3 weeks for 8 courses.
  • Regimen B: Patients receive epirubicin IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive cyclophosphamide orally on days 1-14 or IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8 (CMF). Treatment with CMF repeats every 4 weeks for 4 courses.
  • Arm II: Patients receive 4 courses of adjuvant chemotherapy with FEC as in arm I, regimen A. Patients then receive sequential docetaxel IV over 1 hour once every 3 weeks for 4 courses.

Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are not concurrently enrolled in the Standardization of Breast Radiotherapy (START) trial receive localized radiotherapy once daily, 5 days a week, for 3-5 weeks, according to local practice.

Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are estrogen receptor and/or progesterone receptor positive receive oral tamoxifen once daily for at least 5 years.

Quality of life is assessed at baseline, before course 5, at 3-4 weeks after course 8, and then at 9, 12, 18, and 24 months after initiation of adjuvant chemotherapy.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 3,340 patients (1,670 per treatment arm) will be accrued for this study within 2 years.

Conditions
Breast Cancer
Being tested
CMF regimen, cyclophosphamide, docetaxel, epirubicin hydrochloride, fluorouracil
Keywords
stage I breast cancer, stage II breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2001

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 2
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00033683
Sponsor's protocol ID
CDR0000069311
Other IDs
ICR-TACT, EU-20109
Status last verified
Jun 2005
First submitted
9 Apr 2002
Last updated
9 Feb 2009
Results posted
No

Publications

  • 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.

  • 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.

    PubMed 29179731

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CMF regimen, cyclophosphamide and docetaxel in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 69 sites in 2 countries.

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 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United Kingdom, Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00033683, which also lists 2 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 9 Feb 2009.

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