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

ISRCTN	ISRCTN17775670
DOI	https://doi.org/10.1186/ISRCTN17775670
ClinicalTrials.gov number	NCT00031850
Secondary identifying numbers	IBIS-RAZOR

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Anthony Howell
Scientific

School of Cancer and Enabling Sciences
University of Manchester
The Christie NHS Foundation Trust
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

Phone	+44 (0)161 446 8037
Email	anthony.howell@christie.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Zoladex, Raloxifene
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2000
Completion date	31/05/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	150
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/2000
Date of final enrolment	31/05/2005

School of Cancer and Enabling Sciences

Manchester
M20 4BX
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2018	28/01/2019	Yes	No

28/01/2019: Publication reference added
12/10/2016: No publications found in PubMed, verifying study status with principal investigator.