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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.
Scientific title
A multicentre trial of Tamoxifen to prevent breast cancer in women at increased risk of breast cancer.
Secondary ID [1] 400 0
National Clinical Trials Registry: NCTR63
Universal Trial Number (UTN)
Trial acronym
ANZ92P1/ IBIS-I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of Breast cancer 2039 0
Condition category
Condition code
Cancer 2128 2128 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: Tamoxifen 20 mg/day tablet orally for 5 years
Intervention code [1] 1282 0
Prevention
Comparator / control treatment
Arm B: Placebo (unknown constituents) tablet/day orally for 5 years
Control group
Placebo

Outcomes
Primary outcome [1] 2967 0
Development of histologically confirmed breast cancer (both invasive and non-invasive i.e. including Ductal Carcinoma Insitu (DCIS)).
Timepoint [1] 2967 0
Interim analysis of the data will be by blinded analysis at 6 monthly intervals up to 5 years from baseline
Primary outcome [2] 2968 0
Breast cancer mortality.
Timepoint [2] 2968 0
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
Primary outcome [3] 2969 0
All cause and cause-specific mortality.
Timepoint [3] 2969 0
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
Secondary outcome [1] 5018 0
Occurrence of and mortality from myocardial infarction.
Timepoint [1] 5018 0
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

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)
Minimum age
45 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The clinicians and trial participants are blinded in this study.
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/1992
Actual
1/12/1992
Date of last participant enrolment
Anticipated
Actual
1/03/2001
Date of last data collection
Anticipated
31/12/2017
Actual
31/12/2017
Sample size
Target
7000
Accrual to date
Final
7154
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8699 0
New Zealand
State/province [1] 8699 0

Funding & Sponsors
Funding source category [1] 2283 0
Charities/Societies/Foundations
Name [1] 2283 0
Imperial Cancer Research Fund
Country [1] 2283 0
United Kingdom
Funding source category [2] 2284 0
Charities/Societies/Foundations
Name [2] 2284 0
Cancer Research Campaign
Country [2] 2284 0
United Kingdom
Funding source category [3] 2285 0
Charities/Societies/Foundations
Name [3] 2285 0
Cancer Research UK
Country [3] 2285 0
United Kingdom
Funding source category [4] 2286 0
Government body
Name [4] 2286 0
National Health Medical Research Council grant
Country [4] 2286 0
Australia
Primary sponsor type
University
Name
Queen Mary University of London
Address
Queen Mary, University of London
Mile End Road
London
E1 4NS
Country
United Kingdom
Secondary sponsor category [1] 2064 0
Other Collaborative groups
Name [1] 2064 0
Breast Cancer Trials
Address [1] 2064 0
PO Box 283
The Junction NSW 2291
Country [1] 2064 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4087 0
Austin Health
Ethics committee address [1] 4087 0
Ethics committee country [1] 4087 0
Australia
Date submitted for ethics approval [1] 4087 0
Approval date [1] 4087 0
01/12/1992
Ethics approval number [1] 4087 0
Ethics committee name [2] 4088 0
Bendigo Hospital
Ethics committee address [2] 4088 0
Ethics committee country [2] 4088 0
Australia
Date submitted for ethics approval [2] 4088 0
Approval date [2] 4088 0
Ethics approval number [2] 4088 0
Ethics committee name [3] 4089 0
Border Medical Oncology
Ethics committee address [3] 4089 0
Ethics committee country [3] 4089 0
Australia
Date submitted for ethics approval [3] 4089 0
Approval date [3] 4089 0
Ethics approval number [3] 4089 0
Ethics committee name [4] 4090 0
Canberra Hospital
Ethics committee address [4] 4090 0
Ethics committee country [4] 4090 0
Australia
Date submitted for ethics approval [4] 4090 0
Approval date [4] 4090 0
Ethics approval number [4] 4090 0
Ethics committee name [5] 4091 0
Central Sydney IBIS Centre, (comprising Dubbo Base Hospital, Rachel Forster Hospital, Royal Prince Alfred Hospital)
Ethics committee address [5] 4091 0
Ethics committee country [5] 4091 0
Australia
Date submitted for ethics approval [5] 4091 0
Approval date [5] 4091 0
Ethics approval number [5] 4091 0
Ethics committee name [6] 4092 0
Christchurch IBIS Centre
Ethics committee address [6] 4092 0
Ethics committee country [6] 4092 0
New Zealand
Date submitted for ethics approval [6] 4092 0
Approval date [6] 4092 0
Ethics approval number [6] 4092 0
Ethics committee name [7] 4093 0
Flinders Medical Centre
Ethics committee address [7] 4093 0
Ethics committee country [7] 4093 0
Australia
Date submitted for ethics approval [7] 4093 0
Approval date [7] 4093 0
Ethics approval number [7] 4093 0
Ethics committee name [8] 4094 0
Geelong Hospital
Ethics committee address [8] 4094 0
Ethics committee country [8] 4094 0
Australia
Date submitted for ethics approval [8] 4094 0
Approval date [8] 4094 0
Ethics approval number [8] 4094 0
Ethics committee name [9] 4095 0
Monash Breast Clinic
Ethics committee address [9] 4095 0
Ethics committee country [9] 4095 0
Australia
Date submitted for ethics approval [9] 4095 0
Approval date [9] 4095 0
Ethics approval number [9] 4095 0
Ethics committee name [10] 4096 0
Newcastle Mater Hospital
Ethics committee address [10] 4096 0
Ethics committee country [10] 4096 0
Australia
Date submitted for ethics approval [10] 4096 0
Approval date [10] 4096 0
Ethics approval number [10] 4096 0
Ethics committee name [11] 4097 0
Prince of Wales Hospital
Ethics committee address [11] 4097 0
Ethics committee country [11] 4097 0
Australia
Date submitted for ethics approval [11] 4097 0
Approval date [11] 4097 0
Ethics approval number [11] 4097 0
Ethics committee name [12] 4098 0
Queensland IBIS Centre, (comprising Wesley Breast Clinic and Wesley Medical Centre)
Ethics committee address [12] 4098 0
Ethics committee country [12] 4098 0
Australia
Date submitted for ethics approval [12] 4098 0
Approval date [12] 4098 0
Ethics approval number [12] 4098 0
Ethics committee name [13] 4099 0
Royal Melbourne Hospital
Ethics committee address [13] 4099 0
Ethics committee country [13] 4099 0
Australia
Date submitted for ethics approval [13] 4099 0
Approval date [13] 4099 0
Ethics approval number [13] 4099 0
Ethics committee name [14] 4100 0
Sir Charles Gairdner Hospital
Ethics committee address [14] 4100 0
Ethics committee country [14] 4100 0
Australia
Date submitted for ethics approval [14] 4100 0
Approval date [14] 4100 0
Ethics approval number [14] 4100 0
Ethics committee name [15] 4101 0
St Vincent's Hospital Melbourne
Ethics committee address [15] 4101 0
Ethics committee country [15] 4101 0
Australia
Date submitted for ethics approval [15] 4101 0
Approval date [15] 4101 0
Ethics approval number [15] 4101 0
Ethics committee name [16] 4102 0
St Vincent's Hospital Sydney
Ethics committee address [16] 4102 0
Ethics committee country [16] 4102 0
Australia
Date submitted for ethics approval [16] 4102 0
Approval date [16] 4102 0
Ethics approval number [16] 4102 0
Ethics committee name [17] 4103 0
Tasmanian IBIS Centre
Ethics committee address [17] 4103 0
Ethics committee country [17] 4103 0
Australia
Date submitted for ethics approval [17] 4103 0
Approval date [17] 4103 0
Ethics approval number [17] 4103 0
Ethics committee name [18] 4104 0
Waikato Hospital
Ethics committee address [18] 4104 0
Ethics committee country [18] 4104 0
New Zealand
Date submitted for ethics approval [18] 4104 0
Approval date [18] 4104 0
Ethics approval number [18] 4104 0
Ethics committee name [19] 4105 0
Westmead Hospital
Ethics committee address [19] 4105 0
Ethics committee country [19] 4105 0
Australia
Date submitted for ethics approval [19] 4105 0
Approval date [19] 4105 0
Ethics approval number [19] 4105 0

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
Trial website
https://www.ibis-trials.org/index.php/thetrials/ibistrials/ibis-1
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.
Public notes
Breast Cancer Trials formerly known as the Australia & New Zealand Breast Cancer Trials Group.

Contacts
Principal investigator
Name 35139 0
Dr Janine Lombard
Address 35139 0
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
Country 35139 0
Australia
Phone 35139 0
+61 (02) 4014-3584
Fax 35139 0
Email 35139 0
[email protected]
Contact person for public queries
Name 10471 0
Corinna Beckmore
Address 10471 0
BCT
PO Box 283
The Junction NSW 2291
Country 10471 0
Australia
Phone 10471 0
+61 2 4925 5235
Fax 10471 0
+61 2 4925 3068
Email 10471 0
[email protected]
Contact person for scientific queries
Name 1399 0
Janine Lombard
Address 1399 0
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
Country 1399 0
Australia
Phone 1399 0
+61 (02) 4014-3584
Fax 1399 0
Email 1399 0
[email protected]

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