Combination Chemotherapy in Treating Women With Resected Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer
Eligibility Criteria
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
Sites / Locations
- U.Z. Gasthuisberg
- North Devon District Hospital
- Royal United Hospital
- Queen Elizabeth Hospital at University of Birmingham
- City Hospital - Birmingham
- Blackpool Victoria Hospital
- Pilgrim Hospital
- Bradford Hospitals NHS Trust
- Royal Sussex County Hospital
- Bristol Haematology and Oncology Centre
- West Suffolk Hospital
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
- Broomfield Hospital
- Cheltenham General Hospital
- Essex County Hospital
- Walsgrave Hospital
- Derbyshire Royal Infirmary
- Royal Devon and Exeter Hospital
- Diana Princess of Wales Hospital
- St. Luke's Cancer Centre at Royal Surrey County Hospital
- Royal Free and University College Medical School
- Huddersfield Royal Infirmary
- Princess Royal Hospital
- Ipswich Hospital NHS Trust
- Queen Elizabeth Hospital
- Cookridge Hospital at Leeds Teaching Hospital NHS Trust
- Leeds Cancer Centre at St. James's University Hospital
- Leicester Royal Infirmary
- Saint Bartholomew's Hospital
- Guy's Hospital
- St. Georges Hospital Medical School
- Charing Cross Hospital
- Meyerstein Institute of Oncology at University College of London Hospitals
- Maidstone Hospital
- Christie Hospital N.H.S. Trust
- Clatterbridge Centre for Oncology NHS Trust
- Northern Centre for Cancer Treatment at Newcastle General Hospital
- Northampton General Hospital NHS Trust
- Mount Vernon Hospital
- Oxford Radcliffe Hospital
- Peterborough Hospitals Trust
- Portsmouth Oncology Centre at Saint Mary's Hospital
- Royal Preston Hospital
- Berkshire Cancer Centre at Royal Berkshire Hospital
- Alexandra Healthcare NHS
- Oldchurch Hospital
- Salisbury District Hospital
- Scunthorpe General Hospital
- Cancer Research Centre at Weston Park Hospital
- Royal Shrewsbury Hospital
- Royal South Hants Hospital
- North Staffs Royal Infirmary
- Royal Marsden NHS Foundation Trust - Surrey
- Taunton and Somerset Hospital
- Torbay Hospital
- Southend NHS Trust Hospital
- New Cross Hospital
- Belfast City Hospital Trust Incorporating Belvoir Park Hospital
- Aberdeen Royal Infirmary
- Ninewells Hospital and Medical School
- Hairmyres Hospital
- Western General Hospital
- Beatson Oncology Centre
- Royal Infirmary - Castle
- Raigmore Hospital
- Bronglais General Hospital - Ceredigion and Mid Wales NHS trust
- Velindre Cancer Center at Velinde Hospital
- Glan Clywd District General Hospital
- Singleton Hospital