Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
12/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.cancer.gov/clinicaltrials/NCRI-IBIS-RAZOR

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

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

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

Publication citations

Additional files

Editorial Notes

12/10/2016: No publications found in PubMed, verifying study status with principal investigator.