Randomised double blind trial to evaluate prevention of breast cancer using tamoxifen in high risk wome
- Conditions
- Women at high risk of developing breast cancerCancerBreast Cancer
- Registration Number
- ISRCTN07027313
- Lead Sponsor
- Royal Marsden Hospital (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 2500
1. Healthy women
2. Aged 30 to 70 years
3. Life expectancy of more than ten years
4. Psychologically and physically suitable for tamoxifen/placebo and long term follow-up
5. At increased risk of breast cancer by virtue of:
a. at least one first degree relative aged under 50 with breast cancer
b. one first degree relative with bilateral breast cancer
c. one first degree relative of any age plus another affected first or second degree relative
d. history of a high risk benign breast biopsy
1. Clinical or screening evidence of breast cancer
2. Pregnant or lactating women
3. Pregnancy risk - unless a disclaimer was signed
4. Oral contraceptives within the previous three months
5. Previous history of non-invasive or invasive breast cancer
6. Previous history of other malignancy (except Basal Cell Carcinoma [BCC] or Carcinoma [CA] in situ of the cervix)
7. History of deep vein thrombosis or pulmonary embolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of histologically confirmed invasive breast cancer
- Secondary Outcome Measures
Name Time Method 1. Death from breast cancer<br>2. Overall survival<br>3. Long-term changes in hormones, lipid profile and bone mineral density<br>4. Incidence of other disease, especially vascular