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
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.