Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Contact information



Primary contact

Ms Paula Stavrinos


Contact details

Wythenshaw Hospital
Southmoor Road
M23 9LT
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Introduction of breast cancer prevention with tamoxifen for high risk premenopausal women in the UK (TAMoxifen Prevention study - TAM-P): a non-randomised study



Study hypothesis

This study aims to determine uptake of tamoxifen for prevention in pre-menopausal women at increased risk of breast cancer. Women will be given a specially designed Decision Aid to assist them in deciding whether to join the study. Qualitative interviews will be conducted, both with a number of women who choose to join the study, and a number of women who decline to join the study. The Decision Aid will be re-designed based on the feedback given in these interviews. In addition, we aim to determine whether it is possible to predict who is most likely to benefit from preventive treatment with tamoxifen, by looking at oestrogen receptor expression and changes in mammographic breast density, lipid profiles, glucose, IGF-1, and body composition, before and after 12 months of tamoxifen treatment. Women will be given feedback about changes to the biomarkers associated with tamoxifen response, and will then be given the option to continue taking tamoxifen for a further four years, or stop at that point. Qualitative interviews will be conducted again at this point with a proportion of women who choose to continue, or discontinue taking tamoxifen. Economic analyses will also be carried out to determine the cost benefit to the NHS of prescribing tamoxifen for prevention in pre-menopausal women.

Ethics approval

Greater Manchester West, First MREC approval date 17/02/2011, ref: 11/H1014/14

Study design

Non-randomised; Interventional and Observational; Design type: Prevention, Qualitative

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

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


Breast cancer


Tamoxifen will be offered to pre-menopausal women at increased risk of breast cancer who attend the Family History Clinic and University Hospital of South Manchester

The intervention used in this study is tamoxifen 20mg to be taken once per day orally, initially for 12 months, with an option to continue for a further 48 months.

Intervention type



Not Applicable

Drug names


Primary outcome measure

Uptake: Recruitment is over an 18-month period so will be assessed at the end of the 18 months

Secondary outcome measures

1. Reduction in breast density measured at 12-30 months
2. Oestrogen receptor (ESR) status and CYP2D6 status, measured from DNA collected from a blood tested at baseline
3. Changes in biomarkers - IGF-1, insulin, glucose and lipids measured from blood samples collected at baseline and after 12 months of tamoxifen use (in addition lipids will be assessed after 2 months of tamoxifen use)
4. Body weight and composition, measured at baseline, and after 2 and 12 months of tamoxifen. This will be measured using the Tanita 180, Tanita UK Ltd scales. Waist and hip measurements will be done using standard tape measures, at baseline, and after 2 and 12 months of tamoxifen
5. Cost-effectiveness - symptom and healthcare resource use diary used to assist in economic evaulation

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Pre-menopausal
2. Attends the Family History Clinic at the Nightingale & Genesis Prevention Centre
3. At moderate or high risk of breast cancer
4. Normal mammogram
5. Willing to use a non-hormonal form of contraception (mirena coil is permitted)
6. Upper Age Limit 46 years ; Lower Age Limit 33 years

Participant type


Age group




Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

Participant exclusion criteria

1. Use of coumarin type anticoagulants
2. Use of droperidol
3. Use of Bupropion
4. Diabetes (type I or II)
5. Use of hormonal contraceptives within 3 monhts of joining the study (mirena coil is permitted)
6. Pregnancy and breastfeeding
7. Prophylactic mastectomy or plans to have this procedure
8. Personal or family history of thromboembolism
9. Previous cancer in the last five years (except basal cell carcinoma or in situ cancer of the cervix)
10. Symptomatic gynaecological problems requiring medication

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Wythenshaw Hospital
M23 9LT
United Kingdom

Sponsor information


University Hospital of South Manchester (UK)

Sponsor details

Wythenshawe Hospital
Southmoor Road
M23 9LT
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Funder name

The Genesis Breast Cancer Prevention Appeal (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/06/2017: No publications found, verifying study status with principal investigator.