Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
NCT ID: NCT00072462
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2980 participants
INTERVENTIONAL
2003-09-30
2021-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Anastrozole
Anastrozole
Anastrozole 1mg + Tamoxifen placebo
Tamoxifen
tamoxifen citrate
Tamoxifen 20mg + Anastrozole placebo
Interventions
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tamoxifen citrate
Tamoxifen 20mg + Anastrozole placebo
Anastrozole
Anastrozole 1mg + Tamoxifen placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of ductal carcinoma in situ within the past 6 months
* Locally excised with tumor-free margins at least 1 mm
* Hormone receptor status:
* Estrogen or progesterone receptor positive
* Equal to or greater than 5% positive cells
PATIENT CHARACTERISTICS:
Age
* 40 to 70
Sex
* Female
Menopausal status
* Postmenopausal, defined as meeting at least 1 of the following criteria:
* Over age 60
* Prior bilateral oophorectomy
* Age 60 or under with a uterus AND amenorrhea for at least the past 12 months
* Age 60 or under without a uterus AND follicle-stimulating hormone greater than 20 IU/L
Performance status
* Not specified
Life expectancy
* At least 10 years
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No prior deep vein thrombosis
* No prior transient ischemic attack
* No prior cerebrovascular accident
Pulmonary
* No prior pulmonary embolism
Other
* No unexplained postmenopausal bleeding
* No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other concurrent medical condition that would preclude study therapy, place the patient at unusual risk, or confound study results
* No evidence of osteoporosis
* Fragility fractures within the spine allowed if T-score level is greater than -4 and consist of no more than 2 fractures
* Psychologically and physically suitable for 5 years of study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* No prior or concurrent tamoxifen use lasting more than 6 months unless treatment was completed more than 5 years ago. Women in IBIS-I can join if off trial therapy for at least 5 years.
* No prior or concurrent raloxifene use lasting more than 6 months unless treatment was completed more than 5 years ago.
* No other prior or concurrent selective estrogen-receptor modulator use lasting more than 6 months unless treatment was completed more than 5 years ago
* No concurrent systemic estrogen-based hormone replacement therapy, including vaginal estrogen preparations
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
* No prior mastectomy
* No planned prophylactic mastectomy
Other
* At least 3 months since prior unapproved or experimental agents
* No concurrent anticoagulants
40 Years
70 Years
FEMALE
No
Sponsors
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Cancer Research UK
OTHER
Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Jack Cuzick, PhD
Role: STUDY_CHAIR
Queen Mary University of London
Anthony Howell
Role: STUDY_CHAIR
University of Manchester
Locations
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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
Inselspital Bern
Bern, , Switzerland
Oncocare Sonnenhof-Klinik Engeriedspital
Bern, , Switzerland
Hopital Cantonal Universitaire de Geneve
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Kantonspital
Lucerne, , Switzerland
Ospedale Beata Vergine
Mendrisio, , Switzerland
Tumor Zentrum ZeTup St. Gallen und Chur
Sankt Gallen, , Switzerland
Switzerland(St. Gallen)
Sankt Gallen, , Switzerland
Regionalspital
Thun, , Switzerland
Turkey(Istanbul University)
Istanbul, , Turkey (Türkiye)
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
Countries
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References
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Juraskova I, Butow P, Lopez A, Seccombe M, Coates A, Boyle F, McCarthy N, Reaby L, Forbes JF. Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS). Health Expect. 2008 Sep;11(3):252-62. doi: 10.1111/j.1369-7625.2008.00498.x.
Forbes JF, Sestak I, Howell A, Bonanni B, Bundred N, Levy C, von Minckwitz G, Eiermann W, Neven P, Stierer M, Holcombe C, Coleman RE, Jones L, Ellis I, Cuzick J; IBIS-II investigators. Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial. Lancet. 2016 Feb 27;387(10021):866-73. doi: 10.1016/S0140-6736(15)01129-0. Epub 2015 Dec 11.
Sestak I, Smith SG, Howell A, Forbes JF, Cuzick J. Early participant-reported symptoms as predictors of adherence to anastrozole in the International Breast Cancer Intervention Studies II. Ann Oncol. 2018 Feb 1;29(2):504-509. doi: 10.1093/annonc/mdx713.
Related Links
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Clinical trial summary from Cancer Research UK Website
IBIS-II website
Other Identifiers
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EU-20226
Identifier Type: -
Identifier Source: secondary_id
BIG-5-02
Identifier Type: -
Identifier Source: secondary_id
IBCSG-31-03-DCIS
Identifier Type: -
Identifier Source: secondary_id
ISRCTN31488319
Identifier Type: -
Identifier Source: secondary_id
ISRCTN37546358
Identifier Type: -
Identifier Source: org_study_id
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