Breast cancer Cancer Breast cancer
Conditions
Interventions
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 t
Sponsors
Queen Mary University of London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All new and recurrent breast cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Breast cancer mortality 2. Thromboembolic events 3. Cardiovascular events 4. Osteoporosis 5. Other relevant side effects | — |
Countries
Australia, Austria, Belgium, Chile, England, Finland, France, Germany, Hungary, India, Ireland, Italy, Malta, New Zealand, Sweden, Switzerland, Türkiye, United Kingdom
Outcome results
None listed