An international multi-centre study of tamoxifen vs placebo in women at increased risk of breast cancer.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12610000134022
• Date of registration: 10/02/2010
• Prospective Registration: No
• Primary sponsor: Queen Mary University of London
• 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.
• Date of first enrolment: 01/12/1992
• Target sample size: 7000
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12610000134022.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 3

Countries of recruitment

Australia, New Zealand

Contacts

• Name: Dr Janine Lombard

• Name: Ms Corinna Beckmore

Key inclusion & exclusion criteria

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)
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

Age minimum: 45 Years
Age maximum: 70 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Prevention of Breast cancer;
Prevention of Breast cancer

Cancer - Breast

Intervention(s)

Arm A: Tamoxifen 20 mg/day tablet orally for 5 years

Primary Outcome(s)

Development of histologically confirmed breast cancer (both invasive and non-invasive i.e. including Ductal Carcinoma Insitu (DCIS)).[Interim analysis of the data will be by blinded analysis at 6 monthly intervals up to 5 years from baseline]

Breast cancer mortality.[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]

All cause and cause-specific mortality.[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(s)

Occurrence of and mortality from myocardial infarction.[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]

Secondary ID(s)

National Clinical Trials Registry: NCTR63

Source(s) of Monetary Support

National Health Medical Research Council grant

Cancer Research UK

Cancer Research Campaign

Imperial Cancer Research Fund

Secondary Sponsor(s)

Breast Cancer Trials

Ethics review

Status: Approved
Approval date:
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Austin Health

Status: Not approved
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Bendigo Hospital

Status: Not approved
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Border Medical Oncology

Status: Not approved
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Canberra Hospital

Status: Not approved
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Central Sydney IBIS Centre, (comprising Dubbo Base Hospital, Rachel Forster Hospital, Royal Prince Alfred Hospital)

Status: Not approved
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Christchurch IBIS Centre

Status: Not approved
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Flinders Medical Centre

Status: Not approved
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Geelong Hospital

Status: Not approved
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Monash Breast Clinic

Status: Not approved
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Newcastle Mater Hospital

Status: Not approved
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Prince of Wales Hospital

Status: Not approved
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Queensland IBIS Centre, (comprising Wesley Breast Clinic and Wesley Medical Centre)

Status: Not approved
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Royal Melbourne Hospital

Status: Not approved
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Sir Charles Gairdner Hospital

Status: Not approved
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St Vincent's Hospital Melbourne

Status: Not approved
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St Vincent's Hospital Sydney

Status: Not approved
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Tasmanian IBIS Centre

Status: Not approved
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Waikato Hospital

Status: Not approved
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Westmead Hospital