Condition category
Cancer
Date applied
25/10/2012
Date assigned
26/10/2012
Last edited
30/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Paula Stavrinos

ORCID ID

Contact details

Wythenshaw Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
-
paula.stavrinos@uhsm.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10296

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

Acronym

TAM-P

Study hypothesis

The 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. We will also be carrying out economic analyses to determine the cost benefit to the NHS of prescribing tamoxifen for prevention in pre-menopausal women.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=10296

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

Interventional

Secondary study design

Non randomised study

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

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

Condition

Breast cancer

Intervention

Tamoxifen, 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

Drug

Phase

Not Applicable

Drug names

Tamoxifen

Primary outcome measures

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, which will be measured from DNA collected from a blood tested at baseline.
3. Changes in biomarkers - IGF-1, insulin, glucose and lipids will be 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, which will be 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 will be used to assist in economic evaulation.

Overall trial start date

02/05/2011

Overall trial end date

30/11/2013

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Female

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

02/05/2011

Recruitment end date

30/11/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wythenshaw Hospital
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

University Hospital of South Manchester (UK)

Sponsor details

Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

The Genesis Breast Cancer Prevention Appeal (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

Publication citations

Additional files

Editorial Notes