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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN53844391

Enrollment

200

Registered

2012-10-26

Start date

2011-05-02

Completion date

Unknown

Last updated

2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Malignant neoplasm of breast

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026