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)
- Conditions
- Breast cancerCancer
- Registration Number
- ISRCTN37546358
- Lead Sponsor
- Queen Mary University of London (UK)
- Brief Summary
2008 Results article in https://www.ncbi.nlm.nih.gov/pubmed/18816321 decision aid sub-study results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26686313 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29126161 adherence results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 2980
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All new and recurrent breast cancer
- Secondary Outcome Measures
Name Time Method <br> 1. Breast cancer mortality<br> 2. Thromboembolic events<br> 3. Cardiovascular events<br> 4. Osteoporosis<br> 5. Other relevant side effects<br>