Contact information
Type
Scientific
Primary contact
Prof Jack Cuzick
ORCID ID
Contact details
Centre for Cancer Prevention
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
+44 (0)20 7882 3504
ibis@qmul.ac.uk
Additional identifiers
EudraCT number
2004-003992-35
ClinicalTrials.gov number
NCT00072462
Protocol/serial number
N/A
Study information
Scientific title
An international multi-centre trial of tamoxifen versus anastrozole in postmenopausal women who have had a recent hormone receptor positive, Ductal Carcinoma In Situ (DCIS)
Acronym
IBIS-II DCIS
Study hypothesis
Primary hypotheses:
1. To determine if anastrozole is at least as effective as tamoxifen in local control and prevention of contralateral disease in women with locally excised Estrogen Receptor (ER) or Progesterone Receptor (PgR) positive DCIS.
2. To compare side effect profiles of tamoxifen and anastrozole.
Secondary hypotheses:
1. To compare the effectiveness of tamoxifen and anastrozole according to the receptor status of the primary or recurrent cancer.
2. To examine the rate of breast cancer occurrence after cessation of tamoxifen or anastrozole.
3. To examine the effect of tamoxifen versus anastrozole on breast cancer mortality.
4. To examine the effect of tamoxifen and anastrozole on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths.
5. To examine tolerability and acceptability of side effects experienced by women on the study.
Please note as of 08/02/2011 the anticipated end date has been extended from 01/12/2008 to 31/12/2011.
As of 23/02/2012, the following changes were made on the record.
Chile and sweden were added to countries of recruitment and Peru, Portugal, Denmark and Finland were deleted.
Anticipated end date was updated from 31/12/2011 to 31/01/2022.
Patient recruitment completed on 31/01/2012 was added.
Ethics approval
The study has been approved by the North West MREC (Multi-centre Research Ethics Committee) and local ethics committees (LREC).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No longer available
Condition
Breast cancer
Intervention
IBIS-II DCIS is a randomised double blind study investigating the use of anastrozole versus tamoxifen in women who have had a recent hormone receptor positive, locally excised DCIS lesion. There are two treatment groups:
Group A: tamoxifen 20 mg and anastrozole placebo
Group B. tamoxifen placebo and anastrozole 1 mg
Each patient will take the two tablets once a day for the next five years.
Intervention type
Drug
Phase
Phase III
Drug names
Tamoxifen, anastrozole
Primary outcome measure
All new and recurrent breast cancer
Secondary outcome measures
1. Breast cancer mortality
2. Thromboembolic events
3. Cardiovascular events
4. Osteoporosis
5. Other relevant side effects
Overall trial start date
25/05/2003
Overall trial end date
31/01/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 23/02/2012
1. All women must be postmenopausal and between the ages of 40 to 70. Postmenopausal status is defined as meeting one or more of the following criteria:
a. Over the age of 60
b. Bilateral oophorectomy
c. Aged 60 or under with a uterus and amenorrhoea for at least 12 months
d. Aged 60 or under without a uterus and with Follicle-Stimulating Hormone (FSH) more than 30 IU/L
2. Women with locally excised Oestrogen Receptor (ER) positive DCIS excised within 6 months (ER or PR status must be greater than or equal to 5% positive cells)
3. A baseline bone mineral density scan within the last two years (dual-energy X-ray absorptiometry [DXA] either of hip, lumbar spine, forearm) and spinal X-ray will be required for all women
4. A fully informed signed consent form must have been obtained
5. Women who have had Lobular carcinoma in situ.
6. Women who have had Atypical hyperplasia in a benign lesion.
7. A bilateral mammogram must have been taken within the last year.
8. Women must be accessible for treatment and follow up. Participants randomised in this trial must be treated and followed via a participating institution.
Previous inclusion criteria
1. All women must be postmenopausal and between the ages of 40 to 70. Postmenopausal status is defined as meeting one or more of the following criteria:
a. Over the age of 60
b. Bilateral oophorectomy
c. Aged 60 or under with a uterus and amenorrhoea for at least 12 months
d. Aged 60 or under without a uterus and with Follicle-Stimulating Hormone (FSH) more than 30 IU/L
2. Women with locally excised Oestrogen Receptor (ER) positive DCIS diagnosed within the last six months in which there are tumour free margins of at least 1 mm
3. A baseline bone mineral density scan within the last two years (dual-energy X-ray absorptiometry [DXA] either of hip, lumbar spine, forearm) and spinal X-ray will be required for all women
4. A fully informed signed consent form must have been obtained
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Target: 4000. Final: 2980.
Participant exclusion criteria
Current exclusion criteria as of 23/02/2012
1. Have had (or are planning to have) their breast removed (a mastectomy)
2. Have had tamoxifen or raloxifene for more than six months in the last five years.
3. Have had any other cancer in the last five years (except non-melanoma skin cancer or carcinoma in situ of the cervix)
4. Are taking medication to thin the blood
5. Have had a stroke
6. Have osteoporosis and fractures of the spine (if this applies, they may be able to take part - the trial doctor will assess each person on an individual basis)
7. Have any other serious medical condition
8. Have been taking part in any other clinical trial within the last three months
9. Any previous breast cancer at any age
10. Life expectancy of less than 10 years or any other medical condition that would significantly interfere with the ability to accept the chemo preventive treatment.
Previous exclusion criteria
1. Have had (or are planning to have) their breast removed (a mastectomy)
2. Have had tamoxifen, raloxifene or other Selective Estrogen Receptor Modulators (SERMs) for more than three months in the past
3. Have had any other cancer in the last five years (except non-melanoma skin cancer or carcinoma in situ of the cervix)
4. Are taking medication to thin the blood
5. Have had a stroke
6. Have osteoporosis and fractures of the spine (if this applies, they may be able to take part - the trial doctor will assess each person on an individual basis)
7. Have any other serious medical condition
8. Have been taking part in any other clinical trial within the last three months
Recruitment start date
25/05/2003
Recruitment end date
31/01/2012
Locations
Countries of recruitment
Australia, Austria, Belgium, Chile, Finland, France, Germany, Hungary, India, Ireland, Italy, Malta, New Zealand, Sweden, Switzerland, Turkey, United Kingdom
Trial participating centre
Wolfson Institute of Preventive Medicine
London
EC1M 6BQ
United Kingdom
Sponsor information
Organisation
Queen Mary University of London (UK)
Sponsor details
Dr Mays Jawad
Research & Development Governance Operations Manager
Joint Research Management Office
5 Walden Street
London
E1 2EF
United Kingdom
+44 (0)207 882 7275
sponsorsrep@bartshealth.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2008 decision aid sub-study results in https://www.ncbi.nlm.nih.gov/pubmed/18816321
2. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26686313
3. 2018 adherence results in https://www.ncbi.nlm.nih.gov/pubmed/29126161