Condition category
Cancer
Date applied
16/11/2006
Date assigned
26/01/2007
Last edited
08/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Trevor Powles

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

283A

Study information

Scientific title

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

Approved by the Royal Marsden Hospital Ethics Committee in October 1986.

Study design

Randomised, controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Tamoxifen

Primary outcome measures

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 trial start date

01/10/1986

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

2500

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

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Parkside Oncology Clinic
London
SW19 5NB
United Kingdom

Sponsor information

Organisation

Royal Marsden Hospital (UK)

Sponsor details

Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.royalmarsden.nhs.uk/rmh

Funders

Funder type

Hospital/treatment centre

Funder name

The Royal Marsden Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results publication: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=9672274

Publication citations

  1. Results publication

    Powles T, Eeles R, Ashley S, Easton D, Chang J, Dowsett M, Tidy A, Viggers J, Davey J, Interim analysis of the incidence of breast cancer in the Royal Marsden Hospital tamoxifen randomised chemoprevention trial., Lancet, 1998, 352, 9122, 98-101, doi: 10.1016/S0140-6736(98)85012-5.

Additional files

Editorial Notes