Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery (TACT2)
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, stage IIIA breast cancer, male breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histological diagnosis of invasive breast carcinoma Cytological proof of malignancy alone is not sufficient Early stage disease (T0-3, N0-2, M0) without clinical suspicion or evidence of distant metastases on routine staging No locally advanced breast cancer (T4 and/or N3 disease) Completely resected disease by breast-conserving surgery with axillary node clearance or modified radical mastectomy within the past 4-8 weeks Negative surgical margins required, unless either of the following are true: Deep surgical margins after full thickness resection Noninvasive cancer at surgical margins for which a mastectomy is planned after completion of study chemotherapy No contraindication for or refusal of postoperative radiotherapy in patients who underwent prior breast-conserving surgery Definite indication for adjuvant chemotherapy No prior or current invasive breast cancer or bilateral breast cancer Prior surgically-treated ductal carcinoma in situ or lobular carcinoma in situ allowed Hormone receptor status: Estrogen receptor- and/or progesterone receptor-positive or -negative tumor PATIENT CHARACTERISTICS: Sex: male or female Menopausal status: premenopausal or postmenopausal No previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or any cancer from which the patient has been disease-free for 10 years and for which treatment consisted solely of resection ECOG status 0 or 1 Hemoglobin > 9 g/dL WBC > 3,000/mm³ Platelet count > 10,000/mm³ Bilirubin normal (unless due to known Gilbert's disease) AST and ALT ≤ 1.5 times upper limit of normal (ULN) Albumin normal Creatinine ≤ 1.5 times ULN Creatinine clearance > 50 mL/min No active, uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception No concurrent medical, psychiatric, or geographic problems that might prevent completion of treatment or follow-up Available for a minimum of 5 years' follow-up No known serious viral infection such as active hepatitis B, hepatitis C, or HIV No significant cardiac disease, such as impaired left ventricular function or active angina requiring regular anti-anginal medication and/or resulting in restricted physical activity No history of significant renal impairment or disease PRIOR CONCURRENT THERAPY: No simultaneous participation in the active intervention phase of another treatment trial Not being approached or recruited for another trial within 2 months of study entry No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except for either of the following: Previous radiotherapy for basal cell carcinoma Previous preoperative endocrine therapy, provided there was no evidence of progression during this therapy, it lasted for less than 6 weeks in duration, and it was stopped at least one month prior to trial entry Concurrent luteinizing hormone-releasing hormone analog therapy allowed for premenopausal patients More than 4 weeks since prior hormone replacement therapy (HRT) or pre-operative endocrine therapy No prior breast conserving surgery if there is a contradiction for or refusal of postoperative radiotherapy
Sites / Locations
- William Harvey Hospital
- Wansbeck General Hospital
- Tameside General Hospital
- North Devon District Hospital
- Furness General Hospital
- Basildon University Hospital
- Basingstoke and North Hampshire NHS Foundation Trust
- Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
- City Hospital - Birmingham
- Birmingham Heartlands Hospital
- Royal Blackburn Hospital
- Blackpool Victoria Hospital
- Royal Bolton Hospital
- Bradford Royal Infirmary
- Sussex Cancer Centre at Royal Sussex County Hospital
- Bristol Haematology and Oncology Centre
- Broomfield Hospital
- Burnley General Hospital
- Queen's Hospital
- West Suffolk Hospital
- Addenbrooke's Hospital
- Kent and Canterbury Hospital
- Cheltenham General Hospital
- Halton Hospital
- Chesterfield Royal Hospital
- Saint Richards Hospital
- Essex County Hospital
- Walsgrave Hospital
- Darent Valley Hospital
- Derbyshire Royal Infirmary
- Dewsbury and District Hospital
- Doncaster Royal Infirmary
- Russells Hall Hospital
- University Hospital of North Durham
- Eastbourne District General Hospital
- Royal Devon and Exeter Hospital
- Queen Elizabeth Hospital
- Gloucestershire Royal Hospital
- Diana Princess of Wales Hospital
- St. Luke's Cancer Centre at Royal Surrey County Hospital
- UCL Cancer Institute
- Hereford Hospitals NHS Trust
- Wycombe General Hospital
- Huddersfield Royal Infirmary
- Princess Royal Hospital at Hull and East Yorkshire NHS Trust
- King George Hospital
- Ipswich Hospital
- West Middlesex University Hospital
- Airedale General Hospital
- Kettering General Hosptial
- Kidderminster Hospital
- Queen Elizabeth Hospital
- Royal Albert Edward Infirmary
- Royal Lancaster Infirmary
- Cookridge Hospital
- National Cancer Research Network
- Cancer Research UK Clinical Centre at St. James's University Hospital
- Leeds Cancer Centre at St. James's University Hospital
- Royal Liverpool University Hospital
- Aintree University Hospital
- Barts and the London School of Medicine
- Whittington Hospital
- University College Hospital
- Guy's Hospital
- King's College Hospital
- St. George's Hospital
- St. Mary's Hospital
- Charing Cross Hospital
- Macclesfield District General Hospital
- Maidstone Hospital
- Christie Hospital
- Withington Hospital
- North Manchester General Hospital - Penine Actute Hospitals Trust
- Queen Elizabeth The Queen Mother Hospital
- Clatterbridge Centre for Oncology
- James Cook University Hospital
- Northern Centre for Cancer Treatment at Newcastle General Hospital
- St. Mary's Hospital
- James Paget Hospital
- North Tyneside Hospital
- Friarage Hospital
- Northampton General Hospital NHS Trust
- Norfolk and Norwich University Hospital
- King's Mills Hospital
- Nottingham City Hospital NHS Trust
- George Eliot Hospital
- Royal Oldham Hospital
- Radcliffe Infirmary NHS Trust
- Churchill Hospital
- Peterborough Hospitals Trust
- Pontefract General Infirmary
- Whiston Hospital
- Royal Preston Hospital
- Alexandra Healthcare NHS
- Oldchurch Hospital
- Conquest Hospital
- Salisbury District Hospital
- Scunthorpe General Hospital
- Cancer Research Centre at Weston Park Hospital
- Royal Shrewsbury Hospital
- Solihull Hospital
- Southampton General Hospital
- Southport and Formby District General Hospital
- Stepping Hill Hospital
- University Hospital of North Staffordshire
- Sunderland Royal Hospital
- Great Western Hospital
- Taunton and Somerset Hospital
- Torbay Hospital
- Royal Cornwall Hospital
- Walsall Manor Hospital
- Warrington Hospital NHS Trust
- South Warwickshire Hospital
- Sandwell General Hospital
- Southend University Hospital NHS Foundation Trust
- Weston General Hospital
- Royal Hampshire County Hospital
- New Cross Hospital
- Worcester Royal Hospital
- Yeovil District Hospital
- Belfast City Hospital Trust Incorporating Belvoir Park Hospital
- Centre for Cancer Research and Cell Biology at Queen's University Belfast
- Altnagelvin Area Hospital
- Aberdeen Royal Infirmary
- Ayr Hospital
- Dumfries & Galloway Royal Infirmary
- Ninewells Hospital
- Queen Margaret Hospital - Dunfermline
- Hairmyres Hospital
- Edinburgh Cancer Centre at Western General Hospital
- Dr Gray's Hospital
- Falkirk & District Royal Infirmary
- Beatson West of Scotland Cancer Centre
- Royal Infirmary - Castle
- Inverclyde Royal Hospital
- Raigmore Hospital
- Crosshouse Hospital
- St. John's Hospital
- Scarborough General Hospital
- Pinderfields General Hospital
- Wishaw General Hospital
- Bronglais District General Hospital
- Ysbyty Gwynedd
- Princess of Wales Hospital
- Velindre Cancer Center at Velindre Hospital
- Withybush General Hospital
- Royal Glamorgan Hospital
- Prince Charles Hospital
- Royal Gwent Hospital
- Glan Clwyd Hospital
- Wrexham Maelor Hospital
- Barnet General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Epi-CMF
Accelerated Epi-CMF
Epi-Capecitabine
Accelerated Epi-Capecitabine