Follow-up phase of a randomised trial of Tamoxifen or placebo for breast cancer prevention in high risk women. [ 2002 - 2004 ]

Research Grant

Researchers: Prof John Forbes (Principal investigator) ,  A/Pr Raymond Snyder ,  Dr Michael Byrne ,  Prof Alan Coates

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 over 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 is called IBIS1 (International Breast cancer Intervention Study) , and is conducted in Australia by the Australian New Zealand Breast Cancer Trials Group (ANZ BCTG), and internationally by the Imperial Cancer Research Fund (ICRF) in London. 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 by November 2000 the target number of women on the trial was reached ahead of schedule - over 7000 internationally including over 2500 from Australia. Follow-up is being completed with planned data analysis within the next three years. Funding for this phase in Australia is now being sought. The ANZ BCTG and over 2500 women at increased risk of breast cancer have demonstrated a remarkable commitment to complete accrual. It is now vitally important that the essential follow-up with careful monitoring is completed to facilitate anaysis of the data at the earliest opportunity. The only other large randomised trial testing tamoxifen (NSABP P-1) ceased and unblinded in 1998, with an average follow-up of less than 4 years. This trial has had to re-commence follow-up to determine longer term tamoxifen effects. The IBIS 1 study is now the only large, blinded trial remaining in the world, and it's follow-up is of very high international importance. The completion of follow-up and the publication of results will have substantial impact worldwide.

Funding Amount $AUD 459,900.00

Funding Scheme NHMRC Project Grants

Notes Clinical Trial/Large Scale