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| 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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN17775670 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | IBIS-RAZOR |
| Public title | 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 |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Breast |
| Study hypothesis | Not provided at time of registration. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material | |
| Anticipated start date | 01/05/2000 |
| Anticipated end date | 31/05/2005 |
| Status of trial | Completed |
| Target number of participants | 150 |
| 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 |
| Primary outcome measure(s) | Not provided at time of registration. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123 Lincoln's Inn Fields London United Kingdom WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator MRC Clinical Trials Unit 222 Euston Road London United Kingdom NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN17775670 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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