Women at high risk of developing breast cancer Cancer Breast Cancer
Conditions
Interventions
20 mg/day oral tamoxifen versus placebo, treatment will continue for up to eight years.
Sponsors
Royal Marsden Hospital (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of histologically confirmed invasive breast cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Death from breast cancer 2. Overall survival 3. Long-term changes in hormones, lipid profile and bone mineral density 4. Incidence of other disease, especially vascular | — |
Countries
United Kingdom
Outcome results
None listed