Randomised double blind trial to evaluate prevention of breast cancer using tamoxifen in high risk women

ISRCTN	ISRCTN07027313
DOI	https://doi.org/10.1186/ISRCTN07027313
Secondary identifying numbers	283A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Prof Trevor Powles
Scientific

Parkside Oncology Clinic
49 Parkside
Wimbledon
London
SW19 5NB
United Kingdom

Study design	Randomised, controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	Tamoplac
Study hypothesis	The hypothesis that oestrogen is an important promoter of carcinogenically induced mammary neoplasia opens up some attractive possibilities for the prevention of clinical breast cancers.
Ethics approval(s)	Approved by the Royal Marsden Hospital Ethics Committee in October 1986.
Condition	Women at high risk of developing breast cancer
Intervention	20 mg/day oral tamoxifen versus placebo, treatment will continue for up to eight years.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Tamoxifen
Primary outcome measure	Incidence of histologically confirmed invasive breast cancer
Secondary outcome measures	1. Death from breast cancer 2. Overall survival 3. Long-term changes in hormones, lipid profile and bone mineral density 4. Incidence of other disease, especially vascular
Overall study start date	01/10/1986
Overall study end date	01/10/2006

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	2500
Participant inclusion criteria	1. Healthy women 2. Aged 30 to 70 years 3. Life expectancy of more than ten years 4. Psychologically and physically suitable for tamoxifen/placebo and long term follow-up 5. At increased risk of breast cancer by virtue of: a. at least one first degree relative aged under 50 with breast cancer b. one first degree relative with bilateral breast cancer c. one first degree relative of any age plus another affected first or second degree relative d. history of a high risk benign breast biopsy
Participant exclusion criteria	1. Clinical or screening evidence of breast cancer 2. Pregnant or lactating women 3. Pregnancy risk - unless a disclaimer was signed 4. Oral contraceptives within the previous three months 5. Previous history of non-invasive or invasive breast cancer 6. Previous history of other malignancy (except Basal Cell Carcinoma [BCC] or Carcinoma [CA] in situ of the cervix) 7. History of deep vein thrombosis or pulmonary embolism
Recruitment start date	01/10/1986
Recruitment end date	01/10/2006

Parkside Oncology Clinic

London
SW19 5NB
United Kingdom

Royal Marsden Hospital (UK)
Hospital/treatment centre

Downs Road
Sutton
Surrey
SM2 5PT
England
United Kingdom

Website	http://www.royalmarsden.nhs.uk/rmh
"ROR"	https://ror.org/034vb5t35

Hospital/treatment centre

The Royal Marsden Hospital (UK)

No information available

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 publication:	11/07/1998		Yes	No