Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Anthony Howell
ORCID ID
Contact details
School of Cancer and Enabling Sciences
University of Manchester
The Christie NHS Foundation Trust
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
+44 (0)161 446 8037
anthony.howell@christie.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00031850
Protocol/serial number
IBIS-RAZOR
Study information
Scientific 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
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Breast cancer
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
Zoladex, Raloxifene
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2000
Overall trial end date
31/05/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
150
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2000
Recruitment end date
31/05/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Cancer and Enabling Sciences
Manchester
M20 4BX
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary