Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
NCT ID: NCT00078832
Last Updated: 2021-10-06
Study Results
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Basic Information
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COMPLETED
PHASE3
3864 participants
INTERVENTIONAL
2003-09-30
2021-05-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well anastrozole works in preventing breast cancer in postmenopausal women who are at increased risk for the disease.
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Detailed Description
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Primary
* Determine the effectiveness of anastrozole in preventing breast cancer in postmenopausal women at increased risk for the disease.
Secondary
* Determine the role of this drug in preventing estrogen receptor-positive breast cancer in these participants.
* Determine the effect of this drug on breast cancer mortality in these participants.
* Determine the effect of this drug on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these participants.
* Determine the tolerability and acceptability of side effects of this drug in these participants.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to participating center. Participants are randomized to 1 of 2 treatment arms.
* Arm I: Participants receive oral anastrozole daily for 5 years.
* Arm II: Participants receive an oral placebo daily for 5 years. In both arms, treatment continues in the absence of the development of breast cancer (including ductal carcinoma in situ), a drop in the T-score below minus 4, or the occurrence of a new fragility fracture.
Participants are followed for at least a further 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
ACCRUAL: A total of 3,864 participants were recruited for this study over 10 years.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
QUADRUPLE
Study Groups
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anastrozole
anastrozole 1mg
anastrozole
aromatase inhibitor
placebo
anastrozole 1mg PLACEBO
placebo
Arimidex placebo
Interventions
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anastrozole
aromatase inhibitor
placebo
Arimidex placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meets at least 1 of the relative risk factors based on age as follows:
* 45 to 70 years of age:
* First-degree relative who developed breast cancer at ≤ 50 years of age
* First-degree relative who developed bilateral breast cancer
* Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer
* Participants having both relatives who are second degree and on the opposite sides of the family must have at least one that was diagnosed at ≤ 50 years of age
* Nulliparous (or first birth at ≥ 30 years of age) and a first-degree relative who developed breast cancer
* Benign biopsy with proliferative disease and a first-degree relative who developed breast cancer
* Mammographic opacity covering at least 50% of the breast in the absence of hormone replacement therapy within the past 3 months
* 60 to 70 years of age:
* First-degree relative with breast cancer at any age
* Age at menopause ≥ 55 years
* Nulliparous or age at first birth ≥ 30 years
* 40 to 44 years of age:
* Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer at ≤ 50 years of age
* First-degree relative with bilateral breast cancer who developed the first breast cancer at ≤ 50 years of age
* Nulliparous (or first birth at ≥ 30 years of age) and a first-degree relative who developed breast cancer at ≤ 40 years of age
* Benign biopsy with proliferative disease and a first-degree relative who developed breast cancer at ≤ 40 years of age
* All age groups (40 to 70 ears of age) with a 10-year risk \> 5% who do not fit into the above categories are allowed
* Clearly apparent family history AND/OR other risk factors indicating appropriate increased risk of breast cancer for age
* The following prior breast conditions are allowed (for all age groups):
* Lobular carcinoma in situ
* Atypical ductal or lobular hyperplasia in a benign lesion
* Ductal carcinoma in-situ (DCIS), diagnosed within the past 6 months, and treated by mastectomy
* No evidence of breast cancer on mammogram within the past year
* Hormone receptor status:
* For patients with prior DCIS, estrogen- or progesterone-receptor status must have been positive
* Must have had greater than or equal to 5% positive cells
PATIENT CHARACTERISTICS:
Age
* 40 to 70
Sex
* Female
Menopausal status
* Postmenopausal, defined as at least 1 of the following:
* Over 60 years of age
* Bilateral oophorectomy
* ≤ 60 years of age with a uterus and amenorrhea for at least 12 months
* ≤ 60 years of age without a uterus and with follicle-stimulating hormone levels \> 30 IU/L
Performance status
* Not specified
Life expectancy
* At least 10 years
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Psychologically and physically suitable to receive 5 years of anti-estrogen therapy
* No cancer within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix
* No evidence of osteoporosis or fragility fractures within the spine
* Participants with a T-score \> minus 4 and no more than 2 fragility fractures are allowed
* No concurrent severe disease that would place the participant at unusual risk or confound the results of the study
* No other medical condition that would preclude the ability to receive the study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* No prior tamoxifen, raloxifene, or other selective estrogen receptor modulator (SERM) use for more than 6 months in duration unless an IBIS-I participant (must have been off trial therapy for at least 5 years.
* No concurrent tamoxifen, raloxifene, or other SERM
* No concurrent estrogen-based hormone replacement therapy
* No concurrent systemic estrogen replacement therapy, including vaginal estrogen preparations
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
* No prior prophylactic mastectomy
* No concurrent prophylactic mastectomy
Other
* More than 6 months since prior investigational drugs
40 Years
70 Years
FEMALE
Yes
Sponsors
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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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Newcastle Mater Hospital
Newcastle, New South Wales, Australia
University Hospitals
Leuven, , Belgium
Corporacion Nacional del Cancer
Santiago, , Chile
Herlev University Hospital
Hørsholm, , Denmark
Pirkanmaa Cancer Society
Tampere, , Finland
GBG Forschungs GMBH
Frankfurt, , Germany
Department of Oncotherapy, University of Szeged
Szeged, , Hungary
Beaumont Hospital
Dublin, Beaumont, Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Tallaght, Ireland
Cork University Hospital
Cork, , Ireland
South Infirmary Victoria Hospital
Cork, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
St. James's Hospital
Dublin, , Ireland
University College Hospital
Galway, , Ireland
Mid-Western Cancer Centre at Mid-Western Regional Hospital
Limerick, , Ireland
Sligo General Hospital
Sligo, , Ireland
Division of Chemoprevention
Milan, , Italy
Sir Paul Boffa Hospital, Harper Lane
Floriana, , Malta
Instituto Portugues De Oncologia, Gabinete De Estudos Clinicos
Lisbon, , Portugal
Inselspital Bern
Bern, , Switzerland
Oncocare Sonnenhof-Klinik Engeriedspital
Bern, , Switzerland
Hopital Cantonal Universitaire de Geneve
Geneva, , Switzerland
Ospedale Beata Vergine
Mendrisio, , Switzerland
Tumor Zentrum ZeTup St. Gallen und Chur
Sankt Gallen, , Switzerland
Regionalspital
Thun, , Switzerland
Ortaklar cad Pehlivan sok, Basak koviah ap.
Istanbul, , Turkey (Türkiye)
Tameside General Hospital
Ashton-under-Lyne, England, United Kingdom
Royal Bolton Hospital
Bolton, England, United Kingdom
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom
St. Luke's Hospital
Bradford, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Frenchay Hospital
Bristol, England, United Kingdom
Bristol Royal Infirmary
Bristol, England, United Kingdom
Queen's Hospital
Burton-on-Trent, England, United Kingdom
Broomfield Hospital
Chelmsford, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom
Countess of Chester Hospital
Chester, England, United Kingdom
Essex County Hospital
Colchester, England, United Kingdom
Royal Derby Hospital
Derby, England, United Kingdom
Saint Margaret's Hospital,
Epping, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Frimley Park Hospital
Frimley, England, United Kingdom
Conquest Hospital
Hastings, England, United Kingdom
Castle Hill Hospital
Hull, England, United Kingdom
Airedale General Hospital
Keighley, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Lincoln County Hospital
Lincoln, England, United Kingdom
Royal Liverpool University Hospital
Liverpool, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Guy's Hospital
London, England, United Kingdom
Royal Marsden - London
London, England, United Kingdom
Macclesfield District General Hospital
Macclesfield, England, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, United Kingdom
Ninewells Hospital
Dundee, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Singleton Hospital
Swansea, Wales, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Lincoln County Hospital
Grantham, , United Kingdom
Calderdale Royal Hospital
Huddersfield, , United Kingdom
Royal Free and UCL Medical School
London, , United Kingdom
Paterson Institute for Cancer Research
Manchester, , United Kingdom
Northwick Park Hospital
Middlesex, , United Kingdom
School of Surgical & Reproductive Sciences
Newcastle, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Department of General Surgery Pennine Acute Hospitals NHS Trust
Oldham, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Cancer Clinical Trials Centre
Sheffield, , United Kingdom
Weston Park Hospital, Cancer Clinical Trials Centre, Department of Clinical Oncology
Sheffield, , United Kingdom
Princess Anne Hospital
Southampton, , United Kingdom
Mid Staffordshire NHS Foundation Trust
Stafford, , United Kingdom
Treliske Royal Cornwall Hospital
Truro, , United Kingdom
Wishaw General Hospital
Wishaw, , United Kingdom
Yeovil District Hospital
Yeovil, , United Kingdom
Countries
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References
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Sestak I, Singh S, Cuzick J, Blake GM, Patel R, Gossiel F, Coleman R, Dowsett M, Forbes JF, Howell A, Eastell R. Changes in bone mineral density at 3 years in postmenopausal women receiving anastrozole and risedronate in the IBIS-II bone substudy: an international, double-blind, randomised, placebo-controlled trial. Lancet Oncol. 2014 Dec;15(13):1460-1468. doi: 10.1016/S1470-2045(14)71035-6. Epub 2014 Nov 11.
Jenkins VA, Ambroisine LM, Atkins L, Cuzick J, Howell A, Fallowfield LJ. Effects of anastrozole on cognitive performance in postmenopausal women: a randomised, double-blind chemoprevention trial (IBIS II). Lancet Oncol. 2008 Oct;9(10):953-61. doi: 10.1016/S1470-2045(08)70207-9. Epub 2008 Sep 1.
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.
Cuzick J, Sestak I, Forbes JF, Dowsett M, Knox J, Cawthorn S, Saunders C, Roche N, Mansel RE, von Minckwitz G, Bonanni B, Palva T, Howell A; IBIS-II investigators. Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial. Lancet. 2014 Mar 22;383(9922):1041-8. doi: 10.1016/S0140-6736(13)62292-8. Epub 2013 Dec 12.
Related Links
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Clinical trial summary from Cancer Research UK Website
Other Identifiers
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EU-20227
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2004-003991-12
Identifier Type: -
Identifier Source: secondary_id
ISRCTN31488319
Identifier Type: -
Identifier Source: org_study_id
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