Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
- Registration Number
- NCT00072462
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ.
PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ.
- Detailed Description
OBJECTIVES:
Primary
* Compare the efficacy of adjuvant tamoxifen vs anastrozole, in terms of local control and prevention of contralateral disease, in postmenopausal women with locally excised ductal carcinoma in situ.
* Compare side effect profiles of these drugs in these patients.
Secondary
* Compare the efficacy of these drugs, according to the receptor status of the primary or recurrent cancer in these patients.
* Compare the rate of breast cancer recurrence and growth of new contralateral tumors after cessation of treatment with these drugs in these patients.
* Compare breast cancer mortality in patients treated with these drugs.
* Compare the effect of these drugs on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these patients.
* Compare the tolerability and acceptability of side effects experienced by patients treated with these drugs.
OUTLINE: This is a randomized, double-blind, multicentre study. Patients are stratified according to participating centre. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral tamoxifen and oral placebo once daily.
* Arm II: Patients receive oral anastrozole and oral placebo once daily. In both arms, treatment continues for 5 years in the absence of disease recurrence or unacceptable toxicity.
Patients are followed annually for 5 years and a further 5 years (minimum) off treatment.
Peer Reviewed and Funded by Cancer Research UK. Sponsored by Queen Mary University of London
ACTUAL ACCRUAL: A total of 2,980 patients were accrued for this study over 9 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2980
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tamoxifen tamoxifen citrate - Anastrozole Anastrozole -
- Primary Outcome Measures
Name Time Method Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
- Secondary Outcome Measures
Name Time Method Number of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). Number of Participants With ER- Breast Cancer Recurrence Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). Number of Breast Cancer Deaths Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). Number of Non-breast Cancer Deaths Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Trial Locations
- Locations (97)
Mid-Western Regional Hospital
🇮🇪Limerick, Ireland
Nottingham City Hospital
🇬🇧Nottingham, England, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
🇬🇧Belfast, Northern Ireland, United Kingdom
Royal Marsden Hospital
🇬🇧London, Please Select, United Kingdom
Countess of Chester Hospital
🇬🇧Chester, United Kingdom
Queens Hospital Burton
🇬🇧Burton, United Kingdom
Belgium
🇧🇪Leuven, Belgium
Chile
🇨🇱Santiago, Chile
Hungary
ðŸ‡ðŸ‡ºSzeged, Hungary
Inselspital Bern
🇨ðŸ‡Bern, Switzerland
Kantonspital
🇨ðŸ‡Luzern, Switzerland
York Hospital
🇬🇧York, United Kingdom
Royal Infirmary of Edinburgh at Little France
🇬🇧Edinburgh, Scotland, United Kingdom
University College Hospital
🇮🇪Galway, Ireland
Oncocare Sonnenhof-Klinik Engeriedspital
🇨ðŸ‡Bern, Switzerland
Colchester General Hospital
🇬🇧Colchester, England, United Kingdom
Austrian Breast & Colorectal Cancer Study Group
🇦🇹Vienna, Austria
St. Vincent's University Hospital
🇮🇪Dublin, Ireland
Sir Paul Boffa Hospital,
🇲🇹Floriana, Malta
Hopital Cantonal Universitaire de Geneve
🇨ðŸ‡Geneva, Switzerland
Newcastle Upon Tyne Hospitals NHS Trust
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
St. Thomas' Hospital
🇬🇧London, England, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
Cork Infirmary
🇮🇪Cork, Ireland
Cork University Hospital
🇮🇪Cork, Ireland
Beaumont Hospital
🇮🇪Dublin, Ireland
Sligo General Hospital
🇮🇪Sligo, Ireland
The Adelaide and Meath Hospital
🇮🇪Tallaght, Ireland
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Regionalspital
🇨ðŸ‡Thun, Switzerland
Frenchay Hospital
🇬🇧Bristol, England, United Kingdom
Royal South Hants Hospital
🇬🇧Southampton, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, United Kingdom
European Institute of Oncology
🇮🇹Milan, Italy
Australia
🇦🇺Newcastle, Australia
Institut Sainte Catherine
🇫🇷Avignon, France
Derbyshire Royal Infirmary
🇬🇧Derby, United Kingdom
Institut Bergonie
🇫🇷Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
CHU Hopital A. Morvan
🇫🇷Brest, France
Clinique Tivoli
🇫🇷Bordeaux, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
CMC Les Ormeaux
🇫🇷Le Havre, France
Lincoln County Hospital
🇬🇧Lincoln, United Kingdom
Centre Hospitalier de Lagny
🇫🇷Lagny Sur Marne, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Centre Hospital Regional Universitaire de Limoges
🇫🇷Limoges, France
Centre Oscar Lambret
🇫🇷Lille, France
Clinique Saint - Pierre
🇫🇷Perpignan, France
Centre Regional Rene Gauducheau
🇫🇷Nantes, France
Centre Hospitalier de Mulhouse
🇫🇷Mulhouse, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Henri Becquerel
🇫🇷Rouen, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Germany
🇩🇪Neu-Isenburg, Germany
Switzerland(St. Gallen)
🇨ðŸ‡(St. Gallen), Switzerland
Sweden
🇸🇪Lund, Sweden
Ospedale Beata Vergine
🇨ðŸ‡Mendrisio, Switzerland
Tumor Zentrum ZeTup St. Gallen und Chur
🇨ðŸ‡St. Gallen, Switzerland
Turkey(Istanbul University)
🇹🇷Istanbul, Turkey
Whittington Hospital
🇬🇧London, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
St. Bartholomew's Hospital
🇬🇧London, Please Select, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Royal Bolton Hospital
🇬🇧Bolton, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Tameside General Hospital
🇬🇧Ashton under Lyne, United Kingdom
St Lukes Hospital
🇬🇧Bradford, United Kingdom
Bristol Infirmary
🇬🇧Bristol, United Kingdom
St Margaret's Hospital
🇬🇧Epping, United Kingdom
Grantham & District Hospital
🇬🇧Grantham, United Kingdom
Conquest Hospital, The Ridge
🇬🇧Hastings, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
Frimley Park Hospital NHS Trust
🇬🇧Frimley, United Kingdom
Airedale General Hospital
🇬🇧Keighley, United Kingdom
Huddersfield Royal Infirmary
🇬🇧Huddersfield, United Kingdom
Leeds St James.
🇬🇧Leeds, United Kingdom
Royal Hospital Haslar
🇬🇧Portsmouth, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Scarborough NHS Trust
🇬🇧Scarborough, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, United Kingdom
Staffordshire General Hospital
🇬🇧Stafford, United Kingdom
Clayton Hospital, Northgate
🇬🇧Wakefield, United Kingdom
Welwyn Garden City Hospital
🇬🇧Welwyn, United Kingdom
Wishaw General Hospital
🇬🇧Wishaw, United Kingdom
Singleton Hospital
🇬🇧Swansea, United Kingdom
Treliske Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Worthing Hospital
🇬🇧Worthing, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, United Kingdom
Castle Hill Hospital
🇬🇧Hull, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, England, United Kingdom