Combination Chemotherapy in Treating Women With Resected Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00033683
- Lead Sponsor
- Institute of Cancer Research, United Kingdom
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (69)
St. Georges Hospital Medical School
🇬🇧London, England, United Kingdom
Huddersfield Royal Infirmary
🇬🇧Huddersfield, West Yorks, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Princess Royal Hospital
🇬🇧Hull, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧King's Lynn, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
🇬🇧Portsmouth Hants, England, United Kingdom
Christie Hospital N.H.S. Trust
🇬🇧Manchester, England, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
🇬🇧Leeds, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Royal Free and University College Medical School
🇬🇧Hampstead, London, England, United Kingdom
Ipswich Hospital NHS Trust
🇬🇧Ipswich, England, United Kingdom
Royal Preston Hospital
🇬🇧Preston, England, United Kingdom
Royal South Hants Hospital
🇬🇧Southampton, England, United Kingdom
North Staffs Royal Infirmary
🇬🇧Stoke-On-Trent, England, United Kingdom
Glan Clywd District General Hospital
🇬🇧Rhyl, Denbighshire, Wales, United Kingdom
Singleton Hospital
🇬🇧Swansea, Wales, United Kingdom
North Devon District Hospital
🇬🇧Barnstaple, England, United Kingdom
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Queen Elizabeth Hospital at University of Birmingham
🇬🇧Birmingham, England, United Kingdom
Pilgrim Hospital
🇬🇧Boston, England, United Kingdom
City Hospital - Birmingham
🇬🇧Birmingham, England, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, England, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
West Suffolk Hospital
🇬🇧Bury St. Edmunds, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Broomfield Hospital
🇬🇧Chelmsford, Essex, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, England, United Kingdom
Essex County Hospital
🇬🇧Colchester, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Diana Princess of Wales Hospital
🇬🇧Grimsby, England, United Kingdom
Bradford Hospitals NHS Trust
🇬🇧Bradford, England, United Kingdom
Northampton General Hospital NHS Trust
🇬🇧Northampton, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Peterborough Hospitals Trust
🇬🇧Peterborough, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
🇬🇧Sutton, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Meyerstein Institute of Oncology at University College of London Hospitals
🇬🇧London, England, United Kingdom
Royal United Hospital
🇬🇧Bath, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
🇬🇧Reading, England, United Kingdom
Alexandra Healthcare NHS
🇬🇧Redditch, Worcestershire, England, United Kingdom
Oldchurch Hospital
🇬🇧Romford, England, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, England, United Kingdom
Scunthorpe General Hospital
🇬🇧Scunthorpe, England, 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, United Kingdom
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, 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
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom
Royal Infirmary - Castle
🇬🇧Glasgow, Scotland, United Kingdom
Raigmore Hospital
🇬🇧Inverness, Scotland, United Kingdom
Bronglais General Hospital - Ceredigion and Mid Wales NHS trust
🇬🇧Aberystwyth, Wales, United Kingdom
Velindre Cancer Center at Velinde Hospital
🇬🇧Cardiff, Wales, United Kingdom
Guy's Hospital
🇬🇧London, England, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom