Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
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
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
England, United Kingdom
Study 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
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
http://www.royalmarsden.nhs.uk/rmh
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results publication: | 11/07/1998 | Yes | No |