Combination Chemotherapy in Treating Women With Resected Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00033683
• Other study ID #: CDR0000069311
• Secondary ID: ICR-TACTEU-20109
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 9, 2002
• Last updated: February 6, 2009
• Start date: February 2001

Study information

• Verified date: June 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• CMF regimen

• cyclophosphamide

• docetaxel

• epirubicin hydrochloride

• fluorouracil

• methotrexate

• tamoxifen citrate

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	U.Z. Gasthuisberg	Leuven
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Bronglais General Hospital - Ceredigion and Mid Wales NHS trust	Aberystwyth	Wales
United Kingdom	North Devon District Hospital	Barnstaple	England
United Kingdom	Royal United Hospital	Bath	England
United Kingdom	Belfast City Hospital Trust Incorporating Belvoir Park Hospital	Belfast	Northern Ireland
United Kingdom	City Hospital - Birmingham	Birmingham	England
United Kingdom	Queen Elizabeth Hospital at University of Birmingham	Birmingham	England
United Kingdom	Blackpool Victoria Hospital	Blackpool	England
United Kingdom	Pilgrim Hospital	Boston	England
United Kingdom	Bradford Hospitals NHS Trust	Bradford	England
United Kingdom	Royal Sussex County Hospital	Brighton	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	West Suffolk Hospital	Bury St. Edmunds	England
United Kingdom	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England
United Kingdom	Velindre Cancer Center at Velinde Hospital	Cardiff	Wales
United Kingdom	Broomfield Hospital	Chelmsford, Essex	England
United Kingdom	Cheltenham General Hospital	Cheltenham	England
United Kingdom	Essex County Hospital	Colchester	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	Hairmyres Hospital	East Kilbride	Scotland
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland
United Kingdom	Royal Infirmary - Castle	Glasgow	Scotland
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	Royal Free and University College Medical School	Hampstead, London	England
United Kingdom	Huddersfield Royal Infirmary	Huddersfield, West Yorks	England
United Kingdom	Princess Royal Hospital	Hull	England
United Kingdom	Raigmore Hospital	Inverness	Scotland
United Kingdom	Ipswich Hospital NHS Trust	Ipswich	England
United Kingdom	Queen Elizabeth Hospital	King's Lynn	England
United Kingdom	Cookridge Hospital at Leeds Teaching Hospital NHS Trust	Leeds	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	Guy's Hospital	London	England
United Kingdom	Meyerstein Institute of Oncology at University College of London Hospitals	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	St. Georges Hospital Medical School	London	England
United Kingdom	Maidstone Hospital	Maidstone	England
United Kingdom	Christie Hospital N.H.S. Trust	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle Upon Tyne	England
United Kingdom	Northampton General Hospital NHS Trust	Northampton	England
United Kingdom	Mount Vernon Hospital	Northwood	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Peterborough Hospitals Trust	Peterborough	England
United Kingdom	Portsmouth Oncology Centre at Saint Mary's Hospital	Portsmouth Hants	England
United Kingdom	Royal Preston Hospital	Preston	England
United Kingdom	Berkshire Cancer Centre at Royal Berkshire Hospital	Reading	England
United Kingdom	Alexandra Healthcare NHS	Redditch, Worcestershire	England
United Kingdom	Glan Clywd District General Hospital	Rhyl, Denbighshire	Wales
United Kingdom	Oldchurch Hospital	Romford	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	Royal South Hants Hospital	Southampton	England
United Kingdom	North Staffs Royal Infirmary	Stoke-On-Trent	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England
United Kingdom	Singleton Hospital	Swansea	Wales
United Kingdom	Taunton and Somerset Hospital	Taunton Somerset	England
United Kingdom	Torbay Hospital	Torquay Devon	England
United Kingdom	Southend NHS Trust Hospital	Westcliff-On-Sea	England
United Kingdom	New Cross Hospital	Wolverhampton	England

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

References & Publications (1)

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, 43