Follow-up of a randomised trial of Tamoxifen or placebo for breast cancer prevention in high risk women. [ 2006 - 2010 ]

Research Grant

Researchers: Prof John Forbes (Principal investigator) ,  A/Pr Raymond Snyder ,  Prof Alan Coates ,  Prof Jack Cuzick

Brief description Each year over 10,000 new cases of breast cancer are diagnosed in Australia and over 2500 women die. Tamoxifen, a non-toxic tablet used to control the growth of breast cancer, has safely been taken by more then a million women long term . This project measures tamoxifen's role in preventing breast cancer in high risk women compared to placebo, in a randomised double blind clinical trial. The trial has the potential to benefit many millions of women worldwide. The study, IBIS I (International Breast Cancer Intervention Study), is conducted in Australia by the Australian New Zealand Breast Cancer Trials Group (ANZ BCTG), and internationally by Cancer Research UK (CRUK). On the trial women have regular, annual mammography, 6 monthly clinical checks and take a tablet each day called TAMPLAC, which is either tamoxifen or placebo. The accrual phase has been funded by the NHMRC and the target number of women on the trial was reached ahead of schedule - 7154 internationally including 2674 from Australia. By April 2006 all women will have completed the treatment phase. Funding is now being sought, in Australia, for continued follow-up and investigations of additional risk factors (breast density and types of tumors which occur-have occurred on IBIS I). The ANZ BCTG and all the women involved in IBIS I have demonstrated remarkable commitment. It is now vitally important that the essential follow-up is completed to facilitate analysis of the data, including the post-treatment phase, as well as related risk factors and types of tumors which develop. The only other large randomised trial testing tamoxifen (NSABP P-1) ceased and was unblinded in 1998, with an average follow-up of less than 4 years, the trial had to re-commence follow-up to determine longer term tamoxifen effects. The IBIS 1 study remains the only large, blinded trial in the world, and completion of it's follow-up and analysis is of very high international importance.

Funding Amount $AUD 893,483.73

Funding Scheme NHMRC Project Grants

Notes Standard Project Grant