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)
| ISRCTN | ISRCTN37546358 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37546358 |
| EudraCT/CTIS number | 2004-003992-35 |
| ClinicalTrials.gov number | NCT00072462 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/01/2005
- Registration date
- 26/04/2005
- Last edited
- 24/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Jack Cuzick
Scientific
Scientific
Centre for Cancer Prevention
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
| Phone | +44 (0)20 7882 3504 |
|---|---|
| ibis@qmul.ac.uk |
Miss Joanna Zahedi
Scientific
Scientific
Project Manager/Data Manager
Barts CTU
Centre for Evaluation and Methods
Wolfson Institute of Population Health
Faculty of Medicine and Dentistry
Queen Mary University of London
London
E1 4NS
United Kingdom
| j.zahedi@qmul.ac.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No longer available |
| 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) |
| Study acronym | IBIS-II DCIS |
| Study objectives | 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 the tolerability and acceptability of side effects experienced by women on the study. |
| Ethics approval(s) | The study has been approved by the North West MREC (Multi-centre Research Ethics Committee) and local ethics committees (LREC). |
| Health condition(s) or problem(s) studied | 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 5 years. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 25/05/2003 |
| Completion date | 31/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | Target: 4000. Final: 2980. |
| Total final enrolment | 2980 |
| Key inclusion criteria | Current inclusion criteria as of 23/02/2012: 1. All women must be postmenopausal and between the ages of 40 and 70 years. Postmenopausal status is defined as meeting one or more of the following criteria: 1.1. Over the age of 60 years 1.2. Bilateral oophorectomy 1.3. Aged 60 years or under with a uterus and amenorrhoea for at least 12 months 1.4. Aged 60 years 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 and 70 years. Postmenopausal status is defined as meeting one or more of the following criteria: 1.1. Over the age of 60 years 1.2. Bilateral oophorectomy 1.3. Aged 60 years or under with a uterus and amenorrhoea for at least 12 months 1.4. Aged 60 years 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 6 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 |
| Key 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 6 months in the last 5 years 3. Have had any other cancer in the last 5 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 3 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 chemopreventive 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 3 months in the past 3. Have had any other cancer in the last 5 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 3 months |
| Date of first enrolment | 25/05/2003 |
| Date of final enrolment | 31/01/2012 |
Locations
Countries of recruitment
- Australia
- Austria
- Belgium
- Chile
- England
- Finland
- France
- Germany
- Hungary
- India
- Ireland
- Italy
- Malta
- New Zealand
- Sweden
- Switzerland
- Türkiye
- United Kingdom
Study participating centre
Wolfson Institute of Preventive Medicine
London
EC1M 6BQ
United Kingdom
EC1M 6BQ
United Kingdom
Sponsor information
Queen Mary University of London (UK)
University/education
University/education
Dr Mays Jawad
Research & Development Governance Operations Manager
Joint Research Management Office
5 Walden Street
London
E1 2EF
England
United Kingdom
| Phone | +44 (0)207 882 7275 |
|---|---|
| sponsorsrep@bartshealth.nhs.uk | |
| Website | http://www.jrmo.org.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The initial results were published in 2014, the next major analysis was completed in 2020 and will be published in 2021. The final analysis for the purpose of the CSR will be uploaded within 12 months of the global EoT (31/05/2021). The long-term follow-up for this cohort is now conducted on a new protocol (IRAS 258590, REC 19/LO/0984, registration pending). |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | decision aid sub-study results | 01/09/2008 | Yes | No | |
| Results article | results | 27/02/2016 | Yes | No | |
| Results article | adherence results | 01/02/2018 | Yes | No |
Editorial Notes
24/04/2025: Contact details updated.
06/10/2021: The following changes were made to the trial record:
1. The overall study end date was changed from 31/01/2022 to 31/05/2021.
2. Publication and dissemination plan and IPD sharing statement added.
3. Total final enrolment number added.
10/01/2019: The following changes have been made:
1. The Cancer Research UK plain English summary link has been updated.
2. The EudraCT number has been added.
3. The final enrolment number has been added.
4. The link to the participant information sheet (http://www.ibis-trials.org/files/IBIS-2%20DCIS%20flyer.pdf) has been removed because it is no longer available.
5. Finland was added to the recruitment countries. India was also added as a country that was opened but was closed prematurely.
6. The sponsor contact details were updated.
7. Publication references added.
22/12/2015: Publication reference added.
23/02/2012: The following changes were made to the study record:
1. Chile and Sweden were added to the countries of recruitment and Peru, Portugal, Denmark and Finland were deleted.
2. The overall study end date was updated from 31/12/2011 to 31/01/2022.
3. Recruitment end date 31/01/2012 added.
08/02/2011: The overall study end date has been extended from 01/12/2008 to 31/12/2011.
