Plain English Summary
Plain English summary as of 13/02/2019:
https://www.ibis-trials.org/thetrials/ibistrials/ibis-1
Previous plain English summary:
Not provided at time of registration
Study website
Contact information
Type
Scientific
Contact name
Prof Jack Cuzick
ORCID ID
Contact details
Centre for Cancer Prevention
Wolfson Institute of Preventive Medicine
Charterhouse House Square
London
EC1M 6BQ
United Kingdom
+44 (0)207 882 5973
j.cuzick@qmul.ac.uk
Additional identifiers
EudraCT/CTIS number
2005-003091-38
IRAS number
ClinicalTrials.gov number
NCT00002644
Protocol/serial number
N/A
Study information
Scientific title
An international multicentre study of tamoxifen versus placebo in women at increased risk of breast cancer
Acronym
IBIS-I
Study hypothesis
A study to evaluate the reduction in incidence of, and mortality from, breast cancer associated with taking tamoxifen daily for five years.
Ethics approval(s)
The start of the IBIS I study predated the existence of Multicentre Research Ethics Committees (MREC). However, Central Office for Research Ethics Committees (COREC) have appointed the Central and South Bristol Research Ethics Committee to be the lead REC for the IBIS I study. The Central South Bristol REC reference assigned to study is E3244.
Study design
A multicentre, randomised clinical trial of 7,000 women aged between 45 and 70 years who have a risk of breast cancer at least twice that of the general population
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Prevention
Patient information sheet
Patient information can be found at: https://www.ibis-trials.org/thetrials/ibistrials/ibis-1
Condition
Breast cancer chemoprevention
Intervention
Women were randomised to receive either tamoxifen 20 mg per day for 5 years or placebo
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Tamoxifen
Primary outcome measure
The development of histologically confirmed breast cancer, both invasive and non-invasive (i.e. including ductal carcinoma in situ [DCIS].
Secondary outcome measures
Other cancers, other serious medical conditions or side effects.
Overall study start date
14/04/1992
Overall study end date
30/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
To be eligible, women must satisfy at least one of the entry criteria listed below:
1. A mammogram must have been taken within the last year indicating no malignant disease
2. A signed consent form must have been obtained
Entry criteria:
The entry criteria was based on a relative risk of at least two-fold for women aged 45-70 years, four-fold for women aged 40-44 years and ten-fold for women aged 35-39 years.
Age 45-70 years:
1. First degree relative who developed breast cancer at age 50 or less
2. First degree relative who developed bilateral breast cancer
3. Two or more first or second degree relatives who developed breast cancer
4. Nulliparous and a first degree relative who developed breast cancer
5. Benign biopsy with proliferative disease and a first degree relative who developed breast cancer
6. Lobular carcinoma in situ
7. Atypical ductal or lobular hyperplasia in a benign lesion
8. Women at high risk who do not fit into the above categories (risk equivalent)*
* These women must have clearly apparent family history indicating at least two fold increased risk of breast cancer.
Age 40-44 years
8. Two or more first or second degree relatives who developed breast cancer at age 50 or less
9. First degree relative with bilateral breast cancer who developed the first breast cancer at age 50 or less
10. Nulliparous and a first degree relative who developed breast cancer at age 40 or less
11. Benign biopsy with proliferative disease and a first degree relative who developed breast cancer at age 40 or less
12. Lobular carcinoma in situ
13. Atypical ductal or lobular hyperplasia in a benign lesion
14. Women at high risk who do not fit into the above categories (risk equivalent)*
* These women must have clearly apparent family history indicating at least four fold increased risk of breast cancer.
Age 35-39 years:
15. Two or more first degree relatives who developed breast cancer at age 50 or less
16. First degree relative with bilateral breast cancer who developed the first breast cancer at age 40 or less
17. Lobular carcinoma in situ
18. Women at high risk who do not fit into the above categories (risk equivalent)*
* These women must have clearly apparent family history indicating at least ten fold increased risk of breast cancer.
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
7,000
Participant exclusion criteria
1. Pregnant, or at pregnancy risk. If necessary, pre and peri menopausal women must use non-hormonal contraception during the trial
2. Any previous cancer (except non-melanoma skin cancer or in situ cancer of the cervix)
3. Life expectancy of less than 10 years or other medical condition more serious than the risk of breast cancer
4. Psychologically and physically unsuitable for five years tamoxifen or placebo therapy
5. Current treatment with anti-coagulants
6. Previous deep vein thrombosis or pulmonary embolus
7. Current tamoxifen use
Recruitment start date
14/04/1992
Recruitment end date
30/03/2011
Locations
Countries of recruitment
Australia, Belgium, England, Finland, Switzerland, United Kingdom
Study participating centre
Wolfson Institute of Preventive Medicine
London
EC1M 6BQ
United Kingdom
Sponsor information
Organisation
Queen Mary University of London (UK)
Sponsor details
Joint Research Management Office (JRMO)
Queen Mary Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
England
United Kingdom
+44 (0)207 882 5555
research.governance@qmul.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
Imperial Cancer Reserach Fund, Cancer Research Campaign, Cancer Research UK
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 14/09/2002 | Yes | No | |
Results article | results | 01/02/2003 | Yes | No | |
Results article | results | 21/04/2004 | Yes | No | |
Results article | results | 20/08/2006 | Yes | No | |
Results article | results | 21/02/2007 | Yes | No | |
Results article | results | 15/12/2009 | Yes | No | |
Results article | results | 04/05/2011 | Yes | No | |
Results article | results | 01/07/2012 | Yes | No | |
Results article | substudy results | 01/01/2013 | Yes | No | |
Results article | placebo arm results | 08/10/2014 | Yes | No | |
Results article | extended long-term follow-up results | 01/01/2015 | Yes | No | |
Results article | results | 01/08/2016 | Yes | No | |
Results article | results | 01/03/2017 | Yes | No | |
Results article | results | 10/08/2017 | Yes | No | |
Results article | results | 03/03/2021 | 04/03/2021 | Yes | No |