ISRCTN37546358已完成3 期
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)
Queen Mary University of London (UK)0 个研究点目标入组 2,980 人开始时间: 2005年4月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,980
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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