A randomised trial of zoladex plus raloxifene plus screening versus screening alone for the prevention of breast cancer in premenopausal women at high genetic risk
- Conditions
- Breast cancerCancer
- Registration Number
- ISRCTN17775670
- Lead Sponsor
- Cancer Research UK (CRUK) (UK)
- Brief Summary
1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/29097444 (added 28/01/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 150
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
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ot provided at time of registration
- Secondary Outcome Measures
Name Time Method ot provided at time of registration