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

ISRCTN	ISRCTN53844391
DOI	https://doi.org/10.1186/ISRCTN53844391
Secondary identifying numbers	10296

Submission date: 25/10/2012
Registration date: 26/10/2012
Last edited: 25/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-tamoxifen-prevent-breast-cancer-premenopausal-women-tam-prev

Contact information

Ms Paula Stavrinos
Scientific

Wythenshaw Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Email	paula.stavrinos@uhsm.nhs.uk

Study information

Study design	Non-randomised; Interventional and Observational; Design type: Prevention, Qualitative
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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 acronym	TAM-P
Study objectives	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(s)	Greater Manchester West, First MREC approval date 17/02/2011, ref: 11/H1014/14
Health condition(s) or problem(s) studied	Breast cancer
Intervention	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Tamoxifen
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 study start date	02/05/2011
Completion date	30/11/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 200; UK Sample Size: 200
Total final enrolment	136
Key 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
Key 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
Date of first enrolment	02/05/2011
Date of final enrolment	30/11/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wythenshaw Hospital

Manchester
M23 9LT
United Kingdom

Sponsor information

University Hospital of South Manchester (UK)
Hospital/treatment centre

Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
England
United Kingdom

"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

The Genesis Breast Cancer Prevention Appeal (UK)

No information available

Results and Publications

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results			25/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
08/06/2017: No publications found, verifying study status with principal investigator.