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Spots Global Cancer Trial Database for Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ

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Trial Identification

Brief Title: Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ

Official Title: International Breast Cancer Intervention Study II (IBIS-II) (DCIS)

Study ID: NCT00072462

Conditions

Breast Cancer

Study Description

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.

Eligibility

Minimum Age: 40 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Australia, Newcastle, , Australia

Austrian Breast & Colorectal Cancer Study Group, Vienna, , Austria

Belgium, Leuven, , Belgium

Chile, Santiago, , Chile

Institut Sainte Catherine, Avignon, , France

Institut Bergonie, Bordeaux, , France

Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France

Clinique Tivoli, Bordeaux, , France

CHU Hopital A. Morvan, Brest, , France

Centre Regional Francois Baclesse, Caen, , France

Centre Jean Perrin, Clermont-Ferrand, , France

Centre de Lutte Contre le Cancer Georges-Francois Leclerc, Dijon, , France

Centre Hospitalier de Lagny, Lagny Sur Marne, , France

CMC Les Ormeaux, Le Havre, , France

Centre Oscar Lambret, Lille, , France

Centre Hospital Regional Universitaire de Limoges, Limoges, , France

Centre Hospitalier de Mulhouse, Mulhouse, , France

Centre Regional Rene Gauducheau, Nantes, , France

Clinique Saint - Pierre, Perpignan, , France

Institut Jean Godinot, Reims, , France

Centre Eugene Marquis, Rennes, , France

Centre Henri Becquerel, Rouen, , France

Institut Claudius Regaud, Toulouse, , France

Institut Gustave Roussy, Villejuif, , France

Germany, Neu-Isenburg, , Germany

Hungary, Szeged, , Hungary

Cork Infirmary, Cork, , Ireland

Cork University Hospital, Cork, , Ireland

Beaumont Hospital, Dublin, , Ireland

St. Vincent's University Hospital, Dublin, , Ireland

University College Hospital, Galway, , Ireland

Mid-Western Regional Hospital, Limerick, , Ireland

Sligo General Hospital, Sligo, , Ireland

The Adelaide and Meath Hospital, Tallaght, , Ireland

European Institute of Oncology, Milan, , Italy

Sir Paul Boffa Hospital,, Floriana, , Malta

Sweden, Lund, , Sweden

Switzerland(St. Gallen), (St. Gallen), , Switzerland

Inselspital Bern, Bern, , Switzerland

Oncocare Sonnenhof-Klinik Engeriedspital, Bern, , Switzerland

Hopital Cantonal Universitaire de Geneve, Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland

Kantonspital, Luzern, , Switzerland

Ospedale Beata Vergine, Mendrisio, , Switzerland

Tumor Zentrum ZeTup St. Gallen und Chur, St. Gallen, , Switzerland

Regionalspital, Thun, , Switzerland

Turkey(Istanbul University), Istanbul, , Turkey

Frenchay Hospital, Bristol, England, United Kingdom

Colchester General Hospital, Colchester, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

Royal Liverpool University Hospital, Liverpool, England, United Kingdom

Whittington Hospital, London, England, United Kingdom

St. Thomas' Hospital, London, England, United Kingdom

Christie Hospital, Manchester, England, United Kingdom

Newcastle Upon Tyne Hospitals NHS Trust, Newcastle-Upon-Tyne, England, United Kingdom

Nottingham City Hospital, Nottingham, England, United Kingdom

Royal South Hants Hospital, Southampton, England, United Kingdom

Centre for Cancer Research and Cell Biology at Queen's University Belfast, Belfast, Northern Ireland, United Kingdom

St. Bartholomew's Hospital, London, Please Select, United Kingdom

Royal Marsden Hospital, London, Please Select, United Kingdom

Ninewells Hospital, Dundee, Scotland, United Kingdom

Royal Infirmary of Edinburgh at Little France, Edinburgh, Scotland, United Kingdom

University Hospital of Wales, Cardiff, Wales, United Kingdom

Aberdeen Royal Infirmary, Aberdeen, , United Kingdom

Tameside General Hospital, Ashton under Lyne, , United Kingdom

Royal Bolton Hospital, Bolton, , United Kingdom

Royal Bournemouth Hospital, Bournemouth, , United Kingdom

St Lukes Hospital, Bradford, , United Kingdom

Royal Sussex County Hospital, Brighton, , United Kingdom

Bristol Infirmary, Bristol, , United Kingdom

Queens Hospital Burton, Burton, , United Kingdom

Cheltenham General Hospital, Cheltenham, , United Kingdom

Countess of Chester Hospital, Chester, , United Kingdom

Derbyshire Royal Infirmary, Derby, , United Kingdom

St Margaret's Hospital, Epping, , United Kingdom

Royal Devon and Exeter Hospital, Exeter, , United Kingdom

Frimley Park Hospital NHS Trust, Frimley, , United Kingdom

Grantham & District Hospital, Grantham, , United Kingdom

Conquest Hospital, The Ridge, Hastings, , United Kingdom

Huddersfield Royal Infirmary, Huddersfield, , United Kingdom

Castle Hill Hospital, Hull, , United Kingdom

Airedale General Hospital, Keighley, , United Kingdom

Leeds St James., Leeds, , United Kingdom

Lincoln County Hospital, Lincoln, , United Kingdom

Derriford Hospital, Plymouth, , United Kingdom

Royal Hospital Haslar, Portsmouth, , United Kingdom

Scarborough NHS Trust, Scarborough, , United Kingdom

Weston Park Hospital, Sheffield, , United Kingdom

Staffordshire General Hospital, Stafford, , United Kingdom

Singleton Hospital, Swansea, , United Kingdom

Treliske Royal Cornwall Hospital, Truro, , United Kingdom

Clayton Hospital, Northgate, Wakefield, , United Kingdom

Welwyn Garden City Hospital, Welwyn, , United Kingdom

Wishaw General Hospital, Wishaw, , United Kingdom

Worthing Hospital, Worthing, , United Kingdom

Yeovil District Hospital, Yeovil, , United Kingdom

York Hospital, York, , United Kingdom

Contact Details

Name: Jack Cuzick, PhD

Affiliation: Queen Mary University of London

Role: STUDY_CHAIR

Name: Anthony Howell

Affiliation: University of Manchester

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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