Breast cancer Cancer
Conditions
Interventions
4 weeks of raloxifene tablets to be taken once daily given at visit for Zoladex injection. Zoladex 3.6 g/month plus raloxifene 60 mg/day versus No medical treatment
Sponsors
Cancer Research UK (CRUK) (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 30-45 years at time of randomisation 2. Intact ovarian function; follicle-stimulating hormone (FSH) in premenopausal range if not menstruating 3. High genetic risk of breast cancer established by: a) BRCA1 germ-line mutation b) BRCA2 germ-line mutation c) first-degree relative of known BRCA1/2 mutation carrier d) family with four or more affected relatives with female or male breast cancer or ovarian cancer below age 60 e) two first-degree relatives diagnosed with breast cancer below age 40 f) p53 germ-line mutation (classical Li-Fraumeni syndrome [LFS] only) or first-degree relative of a carrier in a family with classical LFS g) risk equivalent to the above confirmed by a clinical geneticist 4. Baseline mammography which shows no evidence of breast cancer. Malignancy of suspicious lesions must be excluded 5. Acceptable liver and renal function 6. Accessible for follow-up 7. Life expectancy >10 years 8. Informed consent 9. If heterosexually active use of non-hormonal contraception
Exclusion criteria
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed