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

Cancer Research UK (CRUK) (UK)0 个研究点目标入组 150 人开始时间: 2001年7月1日最近更新: 2019年2月11日

适应症

试验速览

•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

发起方

Cancer Research UK (CRUK) (UK)