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ANZ 02P2 : IBIS-II
 
Trial Status:Opened in Australia and New Zealand in June 2005
   
Treatment type:Hormone
   
Stage of Disease:N/A
   
Intent of Treatment:Prevention
   
 
Title:
 
An international multi-centre trial of anastrozole vs placebo in postmenopausal women at increased risk of breast cancer and tamoxifen vs anastrozole in postmenopausal women with hormone sensitive DCIS.
 
 
Summary:
 
IBIS-II is designed to continue the work started in IBIS-I in determining whether a chemopreventive strategy towards breast cancer is beneficial.

IBIS-I was set up to investigate the use of the drug tamoxifen as a preventive agent for women with moderate to increased risk of developing breast cancer. IBIS-II (Prevention) will investigate the use of the drug anastrozole vs placebo in 6000 postmenopausal women aged between 40 and 70 years who have an increased risk of developing breast cancer, and IBIS-II (DCIS) will compare the use of tamoxifen versus anastrozole in 4000 postmenopausal women aged between 40 and 70 years with locally excised hormone sensitive Ductal Carcinoma In-Situ (DCIS).

A bone sub-protocol will also examine the effect of anastrozole on bone mineral density (BMD) and the risk of developing osteoporosis and fractures in 1000 women from the initial entrants in the IBIS-II (Prevention) trial. The ability of bisphosphonate treatment (a drug which prevents bone loss) to reduce the risk in women found to have low bone mineral density at trial entry will be explored.
 
 
Coordinating Group:
 
Australia and New Zealand:
ANZ Breast Cancer Trials Group (ANZ BCTG)
International:
Cancer Research UK (CRUK)
 
Information about IBIS-II in Australia and New Zealand:

The IBIS-II trial was launched in Australia and New Zealand in June 2005.

To participate in IBIS-II, women must be aged 40 – 70, postmenopausal and at increased risk of breast cancer because of a family history, or must have other risk factors such as certain benign breast diseases. Women cannot have had a previous breast cancer, with the exception of hormone sensitive Ductal Carcinoma in Situ (DCIS) diagnosed within six months of joining the trial. Women who have been diagnosed and had surgery for DCIS may be able to participate in either IBIS-II (Prevention), if the DCIS was treated by mastectomy, or IBIS-II (DCIS) if the DCIS was treated by local excision.

Women who would like more information about participating in the IBIS-II trial may phone freecall 1800 640 709 in Australia or freecall 0800 888 656 in New Zealand to leave their contact details. The organisation which is coordinating the IBIS-II trial in Australia and New Zealand, the ANZ Breast Cancer Trials Group, will ensure that the enquiries are forwarded to the nearest local IBIS-II hospital or clinic. A local IBIS-II research nurse will respond to these enquiries as soon as possible.

 
 

 

ANZ BCTG receives research infrastructure funding from the Cancer Institute NSW
and the Australian Government through Cancer Australia

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