English Summary- IBIS-II-Prävention
This text is only available in German.
GBG 28: International Breast Cancer Intervention Study-II (Prevention)
An international multi-centre study of anastrozole vs placebo in postmenopausal women at increased risk of breast cancer
Current Status: Closed
For further information please refer to: www.ibis-trials.org
Trial design:
A multicentre, double-blind, randomised, placebo-controlled clinical trial of 6,000 postmenopausal women aged between 40 and 70 years who are at increased risk of breast cancer
Treatment:
Women will be randomised in a 2-arm design to receive one of the following: Anastrozole 1mg; Anastrozole placebo. Daily over a period of 5 years
Patient population:
- All women must be postmenopausal and aged between 40-70 years. Postmenopausal status is defined as meeting one or more of the following criteria:
- over the age of 60
- bilateral oophorectomy
- aged under 60 years with a uterus and amenorrhoea for at least 12 months
- aged under 60 years without a uterus and with FSH >30 IU/L
- A mammogram must have been taken within the last year and must not show any evidence of breast cancer
- A baseline bone mineral density scan within the last two years (DXA either of hip, lumbar spine or forearm) will be required for all women. A spinal x-ray to assess fragility fractures will also be required, in case DXA values are low
Primary Objective:
To determine if anastrozole is effective in preventing breast cancer in postmenopausal women at increased risk of the disease.
Secondary Objectives:
- To examine the role of anastrozole in preventing oestrogen receptor positive breast cancer
- To examine the effect of anastrozole on breast cancer mortality
- To examine the effect of anastrozole on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths
- To examine tolerability and acceptability of side effects experienced by women on the study
- Quality of life, cognitive function, bone density and other disease markers will also be studied, but are described in separate protocols
Primary Endpoint:
The primary endpoint is the development of histological confirmed breast cancer, both invasive and non-invasive (i.e. including DCIS).
Addenda:
Trial Protocol V7 20th March 2003 Amendment to the Trial protocol for Germany No. 2 Version 06.11.2003
Study Report:
IBIS-II (Prevention) 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 tamoxifen as a preventive agent for women with moderate to increased risk of getting breast cancer. IBIS-II (Prevention) is a randomised double blind control trial but this time will compare anastrozole vs placebo. Anastrozole is a potent new non-steroidal aromatase inhibitor which is highly selective, well tolerated and effective in treating advanced breast cancer. In general terms increased risk is determined from family history, previous benign disease with evidence of proliferation, mammographic dysplasia, and nulliparity and also a DCIS treated by mastectomy. The IBIS-II study, is currently recruiting post-menopausal women to see whether the aromatase inhibitor anastrozole is more effective at preventing breast cancer in post-menopausal women at increased risk. IBIS-II will also investigate whether anastrozole has fewer side effects than tamoxifen. A companion protocol will compare anastrozole to tamoxifen for women with hormone receptor positive DCIS.
The first results of the bone sub study have been presented at SABCS 2007 (#28). German centres are not participating in the bone sub study.
- Study Group: Cancer Research UK (CRUK), German Breast Group (GBG)
- Study Chair Germany: Prof. Dr. med. Gunter von Minckwitz
- Clinical Project Management: Dr. Kai Büchsenschütz
- Data Management / Biometry: CRUK
- Study start: January 2003 (international), November 2003 (Germany)
- Enrolment period: November 2004 - End 2011
- Proposed accrual: International 4000 women, Germany 600 women