A Randomised Phase III Trial Of Anastrozole For Breast Cancer Prevention In Postmenopausal Women At High Risk.
Funder
National Health and Medical Research Council
Funding Amount
$1,593,125.00
Summary
Each year over 10,000 new cases of breast cancer are diagnosed in Australia and over 2500 women die. This project (IBIS 2) is designed to continue the work started by the IBIS 1 prevention trial in determining whether a chemopreventive strategy towards breast cancer is beneficial. IBIS 1 investigated the use of tamoxifen as a preventative agent for women with moderate to increased risk of developing breast cancer and was found to prevent 48% of oestrogen receptor positive breast cancers. IBIS 2 ....Each year over 10,000 new cases of breast cancer are diagnosed in Australia and over 2500 women die. This project (IBIS 2) is designed to continue the work started by the IBIS 1 prevention trial in determining whether a chemopreventive strategy towards breast cancer is beneficial. IBIS 1 investigated the use of tamoxifen as a preventative agent for women with moderate to increased risk of developing breast cancer and was found to prevent 48% of oestrogen receptor positive breast cancers. IBIS 2 investigates anastrozole (Arimidex) as a preventative agent for women with moderate to increased risk of developing breast cancer. It is a multi-centre, randomised, double blind control trial which has the potential to benefit many millions of women worldwide. Anastrozole is an aromatase inhibitor (AI). AIs are a class of endocrine drug which have been shown to be at least as effective as tamoxifen but without the serious side effects seen with tamoxifen. Anastrozole has been shown to be 60% better than tamoxifen in preventing a second breast cancer in women already diagnosed with breast cancer. Women who participate in this study will be postmenopausal with a relative risk of at least two-fold of developing breast cancer. They will be randomised to receive either anastrozole or placebo as a daily tablet, and neither the woman nor her treating clinician will know which treatment has been allocated (double blind study). To investigate whether anastrozole effects bone density, a baseline bone density scan will be measured prior to study entry. This sub-study will investigate bone density in greater detail and the potential role of bone preserving treatment (bisphosphonate). The primary endpoint for the IBIS 2 study is the development of histologically confirmed breast cancer, invasive or non-invasive.Read moreRead less
Follow-up Phase Of A Randomised Trial Of Tamoxifen Or Placebo For Breast Cancer Prevention In High Risk Women.
Funder
National Health and Medical Research Council
Funding Amount
$459,900.00
Summary
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 ....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.Read moreRead less
IBIS II: A Randomised Phase III Trial Of Anastrozole For Breast Cancer Prevention In Postmenopausal Women At High Risk.
Funder
National Health and Medical Research Council
Funding Amount
$1,732,559.00
Summary
The IBIS II trial builds on the successful IBIS 1 breast cancer (BC) prevention trial in determining whether a chemopreventive strategy towards BC is beneficial. Women who are postmenopausal with an increased risk of BC are randomised to receive either anastrozole (an aromatase inhibitor) or placebo as a daily tablet. Neither the woman nor her clinician know which treatment has been allocated (double blind study). IBIS 2 has the potential to benefit many higher risk women worldwide.
Randomised Trials Of Adjuvant Cytotoxic & Endocrine Therapy For Early N+ And N- Breast Cancer
Funder
National Health and Medical Research Council
Funding Amount
$510,509.00
Summary
This application covers 4 adjuvant early breast cancer trials currently part of the Australian New Zealand Breast Cancer Trials Group's national research programme. These trials are international collaborations involving the International Breast Cancer Study Group (IBCSG). Two of the studies concern pre, peri and post-menopausal women with early breast cancer and no involved lymph glands (IBCSG 8 and 9), and two concern pre, peri and post-menopausal women with early breast cancer and involved ly ....This application covers 4 adjuvant early breast cancer trials currently part of the Australian New Zealand Breast Cancer Trials Group's national research programme. These trials are international collaborations involving the International Breast Cancer Study Group (IBCSG). Two of the studies concern pre, peri and post-menopausal women with early breast cancer and no involved lymph glands (IBCSG 8 and 9), and two concern pre, peri and post-menopausal women with early breast cancer and involved lymph glands (IBCSG 13 and 14). In the absence of a definitive cure, the largest gains will come from optimal use of current therapies and new therapies to improve survival, and where possible, to reduce morbidity without the loss of efficacy. These four trials can realistically expect to produce important gains with potential benefit to the many women who are diagnosed with early breast cancer each year. The active accrual period for these studies is complete but all patients are currently on life long follow-up. Patients accrued to trial 8 have a clinical assessment 3 monthly to 2 years, 6 monthly to 5 years, and then annually. For trials 9, 13 and 14 women have a clinical assessment 3 monthly during year 1, 6 monthly for year 2 and then annually.Read moreRead less