Condition category
Cancer
Date applied
07/01/2005
Date assigned
26/04/2005
Last edited
22/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Jack Cuzick

ORCID ID

Contact details

Centre for Cancer Prevention
Wolfson Institute of Preventive Medicine
Room 110
Charterhouse Square
London
EC1M 6BQ
United Kingdom
+44 (0)20 7882 3504
j.cuzick@qmul.ac.uk

Additional identifiers

EudraCT number

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

Patient information can be found at: http://www.ibis-trials.org/files/IBIS-2%20DCIS%20flyer.pdf

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 measures

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

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

4000

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, France, Germany, Hungary, 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

Research and Development
3rd Floor Rutland House
42-46 New Road
London
E1 2AX
United Kingdom
+44 (0)207 882 7250
gerry.leonard@bartsandthelondon.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

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26686313

Publication citations

Additional files

Editorial Notes

22/12/2015: Publication reference added.