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ISRCTN
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ISRCTN17775670
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ClinicalTrials.gov identifier
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NCT00031850
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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IBIS-RAZOR
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Study hypothesis
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Not provided at time of registration.
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/05/2000
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Anticipated end date
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31/05/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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150
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Interventions
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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
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Primary outcome measure(s)
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Not provided at time of registration.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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04/10/2007
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Date ISRCTN assigned
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01/07/2001
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