EUCTR2004-003991-12-GB进行中（未招募）1 期
International Breast Cancer Intervention Study II (Prevention). An international multi-centre study of anastrozole vs placebo in postmenopausal women at increased risk of breast cancer. - IBIS-II (Prevention)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •The trial is open to postmenopausal women between the ages of 40 and 70.
- •Women aged 40-44 must have at least one of the following:
- •Two or more 1st or 2nd degree relatives who developed breast cancer at age 50 or less
- •1st degree relative with bilateral breast cancer who developed the 1st cancer at age 50 or less
- •Nulliparous (or 1st birth age 30 or above) and 1st degree relative who developed breast cancer at age 40 or above
- •Benign biopsy with proliferative disease and 1st degree relative who developed breast cancer at age 40 or less.
- •Women aged 45-70 must have at least one of the following:
- •1st degree relative who developed breast cancer at age 50 or less, or who developed bilateral breast cancer at any age
- •Two or more 1st or 2nd degree relatives who developed breast or ovarian cancer.
- •Nulliparous (or 1st birth at age 30 or above) and 1st degree relative who developed breast cancer
- •Benign biopsy with proliferative disease and 1st degree relative who developed breast cancer
- •Mammographic opacityof at least 50% in absence of HRT use within last 3 months
- •If 60-70, may also have:
- •1st degree relative with breast cancer at any age
- •Age at menopause >= 55 yrs
- •Nulliparous or age at 1st birth 30 or above
- •In addition, women in all the age groups (40-70) who have had certain breast conditions are also eligible. These are:
- •Lobular carcinoma in situ (LCIS)
- •Atypical ductal or lobular hyperplasia in a benign lesion (ADH or LDH)
- •Ductal carcinoma in situ (DCIS), diagnosed within 6 months prior to randomisation and treated by mastectomy, if ER or PgR positive (>5%)
- •Women with 10 year risk of breast cancer greater than 5%, who do not fit into any of the above categories may also be eligible.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Premenopausal women.
- •Any previous cancer in last 5 years (except non-melanoma skin cancer or in situ cancer of cervix).
- •Current or previous tamoxifen or raloxifene or other SERMs use for more than 6 months in the last 5 years. Women in IBIS-I are eligible if they have been off therapy for more than 5 years.
- •Intention to continue to use oestrogen-based HRT.
- •Had or planning to have prophylactic mastectomy.
- •Women with T-scores of less than minus four or with more than two low trauma vertebral fractures.
研究者
相似试验
进行中（未招募）
1 期
International Breast Cancer Intervention Study II (DCIS). An international multi-centre trial of tamoxifen v anastrozole in post-menopausal women with ductal carcinoma in-situ. - IBIS-II (DCIS)Ductal carcinoma in situMedDRA version: 17.0 Level: LLT Classification code 10013806 Term: Ductal carcinoma in situ System Organ Class: 100000004864EUCTR2004-003992-35-GBQueen Mary University of London4,000
进行中（未招募）
1 期
International Breast Cancer Intervention Study II (DCIS). An international multi-centre trial of tamoxifen v anastrozole in post-menopausal women with ductal carcinoma in situ. - IBIS-II (DCIS)Ductal carcinoma in situMedDRA version: 17.0Level: LLTClassification code 10013806Term: Ductal carcinoma in situSystem Organ Class: 100000004864EUCTR2004-003992-35-SEQueen Mary University of London4,000
已完成
3 期
ANZ 02P2 / International Breast cancer Intervention Study: IBIS-II DCISIncreased breast cancer riskCancer - BreastACTRN12605000282684Australia and New Zealand Breast Cancer Trials Group4,000
已完成
3 期
ANZ 02P2 / International Breast cancer Intervention Study: IBIS-II (Prevention)Increased breast cancer riskReproductive Health and Childbirth - Menstruation and menopauseCancer - BreastACTRN12605000216617Australia and New Zealand Breast Cancer Trials Group6,000
已完成
3 期
ANZ 02P2 / International Breast cancer Intervention Study: IBIS-II Bone Sub-ProtocolOsteoporosisACTRN12605000222640Australia and New Zealand Breast Cancer Trials Group1,000