benefit of Tamoxifen
The UK's first study to predict which women with a high risk of breast cancer will benefit from taking tamoxifen as a preventative measure is taking place in Greater Manchester.
Researchers at the Nightingale Centre and Genesis Prevention Centre - based at University Hospital of South Manchester's (UHSM) Wythenshawe Hospital - will invite 200 pre-menopausal women between the ages of 33 and 46 who attend the centre's Family History Clinic to join the study over the next 12 months.
The Tamoxifen Prevention (TAM-Prev) study is funded by the National Institute for Health Research (NIHR) and will assess the benefit of taking tamoxifen to prevent breast cancer - for which it is widely prescribed in the USA - in the chosen demographic. It will look at changes in biomarkers and breast density in the women and also measure the cost-effectiveness of prescribing preventative tamoxifen.
Tamoxifen is currently prescribed in the UK to some breast cancer patients as a form of treatment. However, it is not yet licensed as a preventative drug.
The research team, led by Professor Tony Howell of the Nightingale Centre and Genesis Prevention Centre, hopes to show evidence that may lead to the introduction of tamoxifen as a preventative drug in Family History Clinics throughout the UK.
He explained: "Previous studies have revealed that tamoxifen can prevent up to 40 per cent of breast cancers in high risk women*. We've also shown that tamoxifen can reduce the density of breast tissue, which is also a indicator in preventing breast cancer**. What we now need to do is identify which specific group of women will benefit from taking tamoxifen as a preventative drug, in the hope that we can use it in the UK for that purpose.
"Some women can experience significant side effects when taking tamoxifen and we don't yet know if they'll all ultimately benefit from taking the drug. The Genesis Breast Cancer Prevention Appeal is funding research of this nature to predict, in detail, which women are more likely to contract breast cancer and how we can then prevent it."
The women recruited who agree to take tamoxifen will be prescribed the drug for 12 months before being re-assessed. They will then be given the option to continue taking tamoxifen for a further four years. The study will also measure women's perceptions about continuing the treatment and its potential benefits, based on the individual's first year of results.
Patients will be provided with a specially developed decision aid booklet to help weigh up the risks/benefits of taking tamoxifen and continual efforts will be made to improve the booklet during the one-year recruitment period to the study.
Professor Howell explained: "One of the obstacles we're facing is the current perception of tamoxifen and the potential side effects that can occur from taking the drug. We hope to improve the situation by educating patients and assessing the benefits of them taking tamoxifen. This way, they can assess the pros and cons for themselves when deciding whether to continue taking the treatment."
The research is being funded in a project under the NIHR Research for Patient Benefit (RfPB) programme for approximately £250,000. Additional support is being provided by the Genesis Breast Cancer Prevention Appeal - the UK's only charity entirely dedicated to breast cancer prevention - which is contributing £43,000 towards the project.
Genesis has pledged to raise £1 million to help prevent breast cancer through its 'Million Mile Challenge' - an initiative which encourages people across the country to get fit and healthy whilst raising money to predict and prevent breast cancer. The money raised goes towards funding projects, such as the TAM-Prev study, which enable the charity to help achieve its goal of a future without breast cancer.
Currently, one in 10 women in the UK will develop breast cancer. It is the most common cancer in women in the country, with 45,000 diagnoses and 11,000 deaths from the disease each year.
References
* The International Breast Cancer Intervention Study I (IBIS-I) was designed to investigate the use of tamoxifen in preventing breast cancer in women with a higher risk of developing the disease.
Recruitment of women to IBIS-I ended in March 2001 and the results of the study showed that tamoxifen reduced the incidence of breast cancer by one third in these high-risk women, but with some serious side effects.
**Published in The Journal Of National Cancer Institute - 'Tamoxifen-induced reduction in mammographic density and breast cancer risk reduction: a nested case-control study' - was published in February 2011 and found that the 12 to 18 month change in mammographic breast density is an excellent predictor of response to tamoxifen in the preventive setting.
Article written and supplied by Heath4Media
Last Reviewed: 27 June 2011
Next Review Date: 27 June 2013
