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Anastrozole versus placebo in post-menopausal women at increased risk of breast cancer
ISRCTN ISRCTN31488319
DOI 10.1186/ISRCTN31488319
ClinicalTrials.gov identifier NCT00078832
EudraCT number 2004-003991-12
Public title Anastrozole versus placebo in post-menopausal women at increased risk of breast cancer
Scientific title An international multi-centre randomised controlled trial of anastrozole versus placebo in post-menopausal women at increased risk of breast cancer
Acronym IBIS-II Prevention
Serial number at source N/A
Study hypothesis Primary hypothesis:
To determine if anastrozole is an effective method of preventing breast cancer in postmenopausal women at increased risk of the disease.

Secondary hypothesis:
1. To examine the role of anastrozole in preventing oestrogen receptor positive breast cancer
2. To examine the rate of breast cancer occurrence after cessation of anastrozole
3. To examine the effect of anastrozole on breast cancer mortality
4. To examine the effect of 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 for this trial has been updated from 31/12/2010 to 31/12/2011.

Please note as of 23/02/2012, the following changes were made to the record.
Anticipated end date was updated from 31/12/2011 to 31/01/2022.
Target number of participants were updated from 6000 to 3500 (Patient recruitment ended on 31/01/2012).
France and Austria were removed from countries of recruitment.
Lay summary http://www.cancerhelp.org.uk/trials/a-trial-looking-at-anastrozole-to-prevent-breast-cancer-in-postmenopausal-women
Ethics approval North West MREC (Multi-centre Research Ethics Committee) and local ethics committees (LREC) on 16/09/2002
Study design Randomised controlled trial
Countries of recruitment Australia, Germany, Italy, New Zealand, Switzerland, United Kingdom
Disease/condition/study domain Breast cancer
Participants - inclusion criteria All women must be post-menopausal and between the ages of 40 to 70.
Postmenopausal status is defined as meeting one or more of the following criteria:
1. Over the age of 60 years
2. Bilateral oophorectomy
3. Aged 60 or under with a uterus and amenorrhoea for at least 12 months
4. Aged 60 or under without a uterus and with Follicle-Stimulating Hormone (FSH) more than 30 IU/L

The entry criteria will be age-dependent to reflect the increasing baseline risk with age.

Aged 45 to 70 - the entry criteria are based on a relative risk of at least twofold and are similar to IBIS-I. At least one of the following must be satisfied:
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 or ovarian cancer
4. Nulliparous (or first birth at age 30 or above) 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. Mammographic opacity covering at least 50% of the breast in absence of Hormone Replacement Therapy (HRT) use within the last 3 months

Also aged 60 to 70 - because of their higher baseline risk, women aged 60 to 70 can enter the study with a smaller relative risk:
7. First degree relative with breast cancer at any age
8. Age at menopause 55 years or older
9. Nulliparous or age at first birth 30 years or above

Aged 40 to 44 - who are postmenopausal (usually because of a bilateral oophorectomy) are eligible if they satisfy one or more of the following criteria (approximately fourfold risk or greater):
10. Two or more first or second degree relatives who developed breast or ovarian cancer at age 50 or less
11. First degree relative with bilateral breast cancer who developed the first breast cancer at age 50 or less
12. Nulliparous (or first birth at age 30 or above) and a first degree relative who developed breast cancer at age 40 or less
13. Benign biopsy with proliferative disease and a first degree relative who developed breast cancer at age 40 or less

All Age Groups (40 to 70) - women who have had certain breast conditions will also be eligible. These are:
14. Lobular Carcinoma In Situ (LCIS)
15. Atypical ductal or lobular hyperplasia in a benign lesion
16. Ductal Carcinoma In Situ (DCIS), diagnosed within the last six months, and treated by mastectomy. Oestrogen Receptor (ER) or Progesterone Receptor (PgR) status of DCIS must be known, and must be greater than 5% positive cells.
17. Women with a ten year risk greater than 5%, who do not fit into the above categories (risk equivalent). All risk equivalent women must be approved by the Steering Committee Co-Chairman (London IBIS central office). These women must have clearly apparent family history and/or other risk factors indicating appropriate increased risk of breast cancer for their age. Particularly careful assessment of the risk-benefit for these women should be undertaken before a woman from this group is entered.

All women must have:
1. Had a mammogram taken within the last year and showing no evidence of breast cancer
2. Had 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
3. Signed a consent form after receiving full information about the study
Participants - exclusion criteria Current exclusion criteria as of 23/02/2012
1. Still having periods
2. Have breast cancer, or have had breast cancer in the past (unless you have had DCIS - see criteria for specific age groups)
3. Have had any other cancer in the last five years (except non-melanoma skin cancer or carcinoma in situ of the cervix or Hodgkin’s disease if before the age of 30 and treated with mantle therapy.
4. Have had tamoxifen, raloxifene or other Selective Estrogen Receptor Modulators (SERMs) for more than six months in the past 5 years. (women in IBIS-1 are eligible if they have been off the therapy for more than five years.
5. Want to carry on taking HRT that contains oestrogen
6. Have had (or are planning to have) your breast(s) removed (a mastectomy) to try and prevent breast cancer
7. Have any other serious medical conditions
8. have had treatment with non-approved experimental drugs during the 6 months before randomisation.
9. History of Lactose or gluten intolerance.
10. Life expectancy of less than 10 years or other medical condition which would significantly interfere with the ability to accept the trial treatment.

Previous exclusion criteria
1. Still having periods
2. Have breast cancer, or have had breast cancer in the past (unless you have had DCIS - see criteria for specific age groups)
3. Have had any other cancer in the last five years (except non-melanoma skin cancer or carcinoma in situ of the cervix)
4. Have had tamoxifen, raloxifene or other Selective Estrogen Receptor Modulators (SERMs) for more than three months in the past
5. Have taken part in the IBIS 1 trial
6. Want to carry on taking HRT that contains oestrogen
7. Have had (or are planning to have) your breast(s) removed (a mastectomy) to try and prevent breast cancer
8. Have any other serious medical conditions
9. Have taken any other drug as part of a clinical trial within the last three months
Anticipated start date 25/05/2003
Anticipated end date 31/01/2022
Status of trial Ongoing
Patient information material Patient information can be found at: http://www.ibis-trials.org/docs/leaflets/IBIS-II_leaflet.pdf
Target number of participants 3500 (Patient recruitment ended on 31/01/2012)
Interventions IBIS-II Prevention is a randomised double blind study investigating the use of anastrozole versus placebo in breast cancer prevention. There are two treatment groups:
Group One: anastrozole
Group Two: placebo
Both the anastrozole and the placebo are tablets that are taken once a day for five years.
Primary outcome measure(s) Breast cancer incidence
Secondary outcome measure(s) Current secondary measures as of 23/02/2012
1. Breast cancer mortality
2. Cardiovascular events
3. Osteoporosis
4. Other relevant side effects

Previous secondary measure
1. Breast cancer mortality
2. Thromboembolic events
3. Cardiovascular events
4. Osteoporosis
5. Other relevant side effects
Sources of funding Cancer Research UK (CRUK) (UK)
Trial website http://www.ibis-trials.org/
Publications 2003 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/12903846
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24333009
Contact name Prof  Jack  Cuzick
  Address Centre for Cancer Prevention
Wolfson Institute of Preventive Medicine, Room 110
Charterhouse Square
  City/town London
  Zip/Postcode EC1M 6BQ
  Country United Kingdom
  Tel +44 (0)20 7882 3504
  Fax +44 (0)20 7882 3890
  Email j.cuzick@qmul.ac.uk
Sponsor Queen Mary University of London (UK)
  Address Research and Development
3rd Floor Rutland House
42-46 New Road
  City/town London
  Zip/Postcode E1 2AX
  Country United Kingdom
  Tel +44 (0)20 7882 7250
  Fax +44 (0)20 7882 7276
  Email gerry.leonard@bartsandthelondon.nhs.uk
  Sponsor website: http://www.qmul.ac.uk/
Date applied 07/01/2005
Last edited 11/04/2014
Date ISRCTN assigned 26/04/2005
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