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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12610000134022
Ethics application status
Approved
Date submitted
3/11/1994
Date registered
10/02/2010
Date last updated
12/02/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
An international multi-centre study of tamoxifen vs placebo in women at increased risk of breast cancer.
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Scientific title
A multicentre trial of Tamoxifen to prevent breast cancer in women at increased risk of breast cancer.
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Secondary ID [1]
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National Clinical Trials Registry: NCTR63
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Universal Trial Number (UTN)
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Trial acronym
ANZ92P1/ IBIS-I
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prevention of Breast cancer
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Condition category
Condition code
Cancer
2128
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm A: Tamoxifen 20 mg/day tablet orally for 5 years
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Intervention code [1]
1282
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Prevention
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Comparator / control treatment
Arm B: Placebo (unknown constituents) tablet/day orally for 5 years
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Development of histologically confirmed breast cancer (both invasive and non-invasive i.e. including Ductal Carcinoma Insitu (DCIS)).
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Assessment method [1]
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Timepoint [1]
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Interim analysis of the data will be by blinded analysis at 6 monthly intervals up to 5 years from baseline
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Primary outcome [2]
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Breast cancer mortality.
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Assessment method [2]
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Timepoint [2]
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Interim analysis of the data submitted on case record forms will be analysed to assess breast cancer mortality at 6 monthly intervals up to 5 years from baseline
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Primary outcome [3]
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All cause and cause-specific mortality.
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Assessment method [3]
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Timepoint [3]
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Interim analysis of the data submitted on case record forms will be analysed to assess breast cancer mortality at 6 monthly intervals up to 5 years from baseline
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Secondary outcome [1]
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Occurrence of and mortality from myocardial infarction.
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Assessment method [1]
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Timepoint [1]
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Blood pressure and cholesterol assays will be taken at year 1 and year 5 and interim analysis of the data submitted on case record forms will be analysed to assess breast cancer mortality at 6 monthly intervals up to 5 years from baseline
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Eligibility
Key inclusion criteria
Women must satisfy at least one of the entry criteria listed below.
A) Age 45-70 with at least one of the following:
1. Breast cancer in mother, sister or daughter diagnosed under the age of 50
2. Mother, sister or daughter with cancer in both breasts at any age
3. Any two first or second degree relatives (blood relatives) with breast cancer
4. Having no children, and with a mother or sister with breast cancer at any age
5. Having had a benign biopsy with proliferative disase and a mother, sister or daughter who developed breast cancer at any age
6. Having had a biopsy with lobular carcinoma in situ
7. Having had a benign biopsy with atypical ductal or lobular hyperplasia
8. "Other" equivalent risk to the above (to be confirmed by the Study Chairman
B) Age 40-44 with at least one of the following:
9. Any two first or second degree relatives (blood relatives) with breast cancer under the age of 50
10. Mother, sister, or daughter with breast cancer in both breasts under the age of 50
11. Having no children, and a mother or sister with breast cancer under the age of 40
12. Having had a benign biopsy with proliferative disease and a mother, sister or daughter with breast cancer under the age of 40
13. Having had a biospy with lobular carcinoma in situ
14. Having had a benign biopsy with atypical ductal or lobular hyperplaisa
15. "Other" equivalent risk to the above (to be confirmed by the study chairman)
C) Age 35-39 with at least one of the following:
16. Two relatives, mother, sister or daughter with breast cancer under the age of 50
17. Mother, sister or daughter with breast cancer in both breasts under the age of 40
18. Having had a biopsy with lobular carcinoma in situ
19. "Other" equivalent risk to the above (to be confirmed by the study chairman)
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Minimum age
45
Years
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Maximum age
70
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
a) Women with previous deep vein thrombosis or pulmonary embolus are excluded from the study
b) Women must not use hormonal contraception during the trial
c) Pregnant or at pregnacy risk
d) Life expectany less than 10 years
e) Currently being treated with anticoagulants
f) Previous cancer
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Telephone the National Health & Medical Research Council Clinical Trials Centre and the next randomised trial number for the centre will be issued which will become the woman's trial number and will be used to identify her 6 month supply of tablets. All subsequent supplies of tablets will be based on this number.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
The clinicians and trial participants are blinded in this study.
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
7/04/1992
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Actual
1/12/1992
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Date of last participant enrolment
Anticipated
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Actual
1/03/2001
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Date of last data collection
Anticipated
31/12/2017
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Actual
31/12/2017
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Sample size
Target
7000
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Accrual to date
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Final
7154
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Imperial Cancer Research Fund
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Address [1]
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Cancer Research UK
P.O. Box 123
Lincoln's Inn Fields
London WC2A 3PX
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Country [1]
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United Kingdom
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Cancer Research Campaign
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Address [2]
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Cancer Research UK
P.O. Box 123
Lincoln's Inn Fields
London WC2A 3PX
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Country [2]
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United Kingdom
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Funding source category [3]
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Charities/Societies/Foundations
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Name [3]
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Cancer Research UK
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Address [3]
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Cancer Research UK
P.O. Box 123
Lincoln's Inn Fields
London WC2A 3PX
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Country [3]
2285
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United Kingdom
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Funding source category [4]
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Government body
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Name [4]
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National Health Medical Research Council grant
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Address [4]
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National Health Medical Research Council
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country [4]
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Australia
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Primary sponsor type
University
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Name
Queen Mary University of London
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Address
Queen Mary, University of London
Mile End Road
London
E1 4NS
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Country
United Kingdom
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Secondary sponsor category [1]
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Other Collaborative groups
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Name [1]
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Breast Cancer Trials
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Address [1]
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PO Box 283
The Junction NSW 2291
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Austin Health
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Ethics committee address [1]
4087
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
4087
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Approval date [1]
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01/12/1992
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Ethics approval number [1]
4087
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Ethics committee name [2]
4088
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Bendigo Hospital
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Ethics committee address [2]
4088
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
4088
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Approval date [2]
4088
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Ethics approval number [2]
4088
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Ethics committee name [3]
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Border Medical Oncology
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Ethics committee address [3]
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Ethics committee country [3]
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Australia
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Date submitted for ethics approval [3]
4089
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Approval date [3]
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Ethics approval number [3]
4089
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Ethics committee name [4]
4090
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Canberra Hospital
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Ethics committee address [4]
4090
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Ethics committee country [4]
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Australia
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Date submitted for ethics approval [4]
4090
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Approval date [4]
4090
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Ethics approval number [4]
4090
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Ethics committee name [5]
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Central Sydney IBIS Centre, (comprising Dubbo Base Hospital, Rachel Forster Hospital, Royal Prince Alfred Hospital)
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Ethics committee address [5]
4091
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Ethics committee country [5]
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Australia
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Date submitted for ethics approval [5]
4091
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Approval date [5]
4091
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Ethics approval number [5]
4091
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Ethics committee name [6]
4092
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Christchurch IBIS Centre
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Ethics committee address [6]
4092
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Ethics committee country [6]
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New Zealand
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Date submitted for ethics approval [6]
4092
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Approval date [6]
4092
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Ethics approval number [6]
4092
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Ethics committee name [7]
4093
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Flinders Medical Centre
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Ethics committee address [7]
4093
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Ethics committee country [7]
4093
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Australia
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Date submitted for ethics approval [7]
4093
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Approval date [7]
4093
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Ethics approval number [7]
4093
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Ethics committee name [8]
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Geelong Hospital
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Ethics committee address [8]
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Ethics committee country [8]
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Australia
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Date submitted for ethics approval [8]
4094
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Approval date [8]
4094
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Ethics approval number [8]
4094
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Ethics committee name [9]
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Monash Breast Clinic
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Ethics committee address [9]
4095
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Ethics committee country [9]
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Australia
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Date submitted for ethics approval [9]
4095
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Approval date [9]
4095
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Ethics approval number [9]
4095
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Ethics committee name [10]
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Newcastle Mater Hospital
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Ethics committee address [10]
4096
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Ethics committee country [10]
4096
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Australia
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Date submitted for ethics approval [10]
4096
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Approval date [10]
4096
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Ethics approval number [10]
4096
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Ethics committee name [11]
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Prince of Wales Hospital
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Ethics committee address [11]
4097
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Ethics committee country [11]
4097
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Australia
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Date submitted for ethics approval [11]
4097
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Approval date [11]
4097
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Ethics approval number [11]
4097
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Ethics committee name [12]
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Queensland IBIS Centre, (comprising Wesley Breast Clinic and Wesley Medical Centre)
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Ethics committee address [12]
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Ethics committee country [12]
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Australia
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Date submitted for ethics approval [12]
4098
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Approval date [12]
4098
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Ethics approval number [12]
4098
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Ethics committee name [13]
4099
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Royal Melbourne Hospital
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Ethics committee address [13]
4099
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Ethics committee country [13]
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Australia
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Date submitted for ethics approval [13]
4099
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Approval date [13]
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Ethics approval number [13]
4099
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Ethics committee name [14]
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Sir Charles Gairdner Hospital
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Ethics committee address [14]
4100
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Ethics committee country [14]
4100
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Australia
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Date submitted for ethics approval [14]
4100
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Approval date [14]
4100
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Ethics approval number [14]
4100
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Ethics committee name [15]
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St Vincent's Hospital Melbourne
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Ethics committee address [15]
4101
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Ethics committee country [15]
4101
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Australia
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Date submitted for ethics approval [15]
4101
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Approval date [15]
4101
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Ethics approval number [15]
4101
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Ethics committee name [16]
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St Vincent's Hospital Sydney
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Ethics committee address [16]
4102
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Ethics committee country [16]
4102
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Australia
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Date submitted for ethics approval [16]
4102
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Approval date [16]
4102
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Ethics approval number [16]
4102
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Ethics committee name [17]
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Tasmanian IBIS Centre
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Ethics committee address [17]
4103
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Ethics committee country [17]
4103
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Australia
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Date submitted for ethics approval [17]
4103
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Approval date [17]
4103
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Ethics approval number [17]
4103
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Ethics committee name [18]
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Waikato Hospital
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Ethics committee address [18]
4104
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Ethics committee country [18]
4104
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New Zealand
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Date submitted for ethics approval [18]
4104
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Approval date [18]
4104
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Ethics approval number [18]
4104
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Ethics committee name [19]
4105
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Westmead Hospital
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Ethics committee address [19]
4105
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Ethics committee country [19]
4105
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Australia
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Date submitted for ethics approval [19]
4105
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Approval date [19]
4105
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Ethics approval number [19]
4105
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Summary
Brief summary
A study to evaluate the reduction in incidence of, and mortality from, breast cancer associated with taking tamoxifen daily for five years
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Trial website
https://www.ibis-trials.org/index.php/thetrials/ibistrials/ibis-1
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Trial related presentations / publications
Cuzick J. Continuation of the International Breast Cancer Intervention Study (IBIS). Eur J Cancer 1998; 34(11):1647-1648. Cuzick J. Future possibilities in the prevention of breast cancer: breast cancer prevention trials. Breast Cancer Res Treat 2000; 2:258-263. Fallowfield L, Fleissig A, Edwards R, West A, Powles TJ, Howell A, Cuzick J. Tamoxifen for the prevention of breast cancer: psychosocial impact on women participating in two randomized controlled trials. J Clin Oncol 2001; 19(7):1885-1892. Cuzick J, Forbes J, Edwards R, Baum M, Cawthorn S, Coates A, Hamed A, Howell A, Powles T, for IBIS investigators. First results from the International Breast Cancer Intervention Study (IBIS I): a randomised prevention trial. Lancet 2002; 360:817-824. Cuzick J, Powles T, Veronesi U, Forbes J, Edwards R, Ashley S, Boyle P. Overview of the main outcomes in breast cancer prevention trials. Lancet 2003; 361:296-300. Eckermann SD, Martin AJ, Stockler MR, Simes RJ. The benefits and costs of tamoxifen for breast cancer prevention. ANZ J Public Health 2003; 27(1):34-40. Goldhirsch A, Wood WC, Gelber RD, Coates AS, Thürlimann B, Senn HJ. Meeting highlights: international expert consensus on the primary therapy of early breast cancer. J Clin Oncol 2003; 21(17):3357-3365. Cuzick J, Warwick J, Pinney E, Warren RML, Duffy SW. Tamoxifen and breast density in women at increased risk of breast cancer. J Natl Cancer Inst 2004; 96(8):621-628. Cuzick J, Forbes J, Howell A. Re: Tamoxifen for the prevention of breast cancer: current status of the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Natl Cancer Inst 2006; 98(9):643. Sestak I, Kealy R, Edwards R, Forbes J, Cuzick J. Influence of hormone replacement therapy on tamoxifen-induced vasomotor symptoms. J Clin Oncol 2006; 24(24):3991-3996. Cuzick J, Forbes JF, Sestak I, Cawthorn S, Hamed H, Holli K, Howell A, for the International Breast Cancer Intervention Study (IBIS) I Investigators. Long-term results of tamoxifen prophylaxis for breast cancer - 96 month follow-up of the randomized IBIS I trial. J Natl Cancer Inst 2007; 99(4):272-282. Cuzick J, Warwick J, Pinney E, Duffy SW, Cawthorn S, Howell A, Forbes JF, Warren RML Tamoxifen-induced reduction in mammographic density and breast cancer risk reduction: A nested case-control study J Natl Cancer Inst 2011; 103(9):744-52. Sestak I, Harvie M, Howell A, Forbes JF, Dowsett M, Cuzick J Weight change associated with anastrozole and tamoxifen treatment in postmenopausal women with or at high risk of developing breast cancer Breast Cancer Research and Treatment 2012; 134(2):727-734. Cuzick J, Sestak I, Bonanni B, Costantino JP, Cummings S, DeCensi A, Dowsett M, Forbes JF, Ford L, LaCroix AZ, Mershon J, Mitlak BH, Powles T, Veronesi U, Vogel V, Wickerham DL, for the SERM Chemoprevention of Breast Cancer Overview Group Selective oestrogen receptor modulators in the prevention of breast cancer: an updated meta-analysis of individual participant data. The Lancet 2013; 381(9880):1827-1834. Cuzick J, Sestak I, Cawthorn S, Hamed H, Holli K, Howell A, Forbes JF, on behalf of the IBIS-I Investigators. Tamoxifen for prevention of breast cancer: extended long-term follow-up of the IBIS-I breast cancer prevention trial. Lancet Oncology 2015; 16:67-75. Smith SG, Sestak I, Howell A, Forbes J, Cuzick J. Participant-Reported Symptoms and Their Effect on Long-Term Adherence in the International Breast Cancer Intervention Study I (IBIS I). Journal of Clinical Oncology. 2017; 35(23):2666-2673.
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Public notes
Breast Cancer Trials formerly known as the Australia & New Zealand Breast Cancer Trials Group.
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Contacts
Principal investigator
Name
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Dr Janine Lombard
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Address
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Staff Specialist Medical Oncology / Conjoint Lecturer, University of Newcastle
Calvary Mater Newcastle
Department of Medical Oncology
Locked Bag 7
HUNTER REGION MAIL CENTRE NSW 2310
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Country
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Australia
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Phone
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+61 (02) 4014-3584
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Fax
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Email
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janine.lombard@calvarymater.org.au
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Contact person for public queries
Name
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Corinna Beckmore
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Address
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BCT
PO Box 283
The Junction NSW 2291
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Country
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Australia
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Phone
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+61 2 4925 5235
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Fax
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+61 2 4925 3068
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Email
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corinna.beckmore@bctrials.org.au
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Contact person for scientific queries
Name
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Janine Lombard
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Address
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Staff Specialist Medical Oncology / Conjoint Lecturer, University of Newcastle
Calvary Mater Newcastle
Department of Medical Oncology
Locked Bag 7
HUNTER REGION MAIL CENTRE NSW 2310
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Country
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Australia
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Phone
1399
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+61 (02) 4014-3584
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Fax
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Email
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janine.lombard@calvarymater.org.au
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF