IBIS – Study Details
Country
International
Co-Chairs
J. Cuzick, Cancer Research UK Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Charterhouse Square, LONDON EC1M 6BQ, UNITED KINGDOM. Tel: +44 207 014 0226 Fax: +44 207 014 0269 Email: jack.cuzick@cancer.org.uk
J.F. Forbes, Department of Surgical Oncology, University of Newcastle, Newcastle Mater Misericordiae Hospital, Locked bag 7, Hunter Region Mail Centre, NSW 2310, AUSTRALIA. Tel: +61 2 4921 1155 Fax: +61 2 4929 1966 Email: john.forbes@anzbctg.newcastle.edu.au
A. Howell, CRC Medical Oncology, Christie Hospital, Wilmslow Road, Winthington, MANCHESTER M20 4BX, UNITED KINGDOM. Tel: +44 161 446 8037 Fax: +44 161 446 8000/3299 Email: maria.parker@christie-tr.nwest.nhs.uk
Trial Office
IBIS-II, Cancer Research UK Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Charterhouse Square, LONDON EC1M 6BQ, UNITED KINGDOM. Tel: +44 (0) 20 7014 0236 Fax: +44 (0) 20 7014 0248 Email: ibis@cancer.org.uk
Website
Title
An international multi-centre study of anastrozole versus placebo in postmenopausal women at increased risk of breast cancer. IBIS-II (Prevention).
BIG 05-02a
Coordinator(s)
J. Cuzick, Cancer Research UK Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Charterhouse Square, LONDON EC1M 6BQ, UNITED KINGDOM. Tel: +44 207 014 0226 Fax: +44 207 014 0269 Email: jack.cuzick@cancer.org.uk
J.F. Forbes, Department of Surgical Oncology, University of Newcastle, Newcastle Mater Misericordiae Hospital, Locked bag 7, Hunter Region Mail Centre, NSW 2310, AUSTRALIA. Tel: +61 2 4921 1155 Fax: +61 2 4929 1966 Email: john.forbes@anzbctg.newcastle.edu.au
A. Howell, CRC Medical Oncology, Christie Hospital, Wilmslow Road, Winthington, MANCHESTER M20 4BX, UNITED KINGDOM. Tel: +44 161 446 8037 Fax: +44 161 446 8000/3299 Email: maria.parker@christie-tr.nwest.nhs.uk
Summary
- Opened in Spring 2003
- Target accrual: 6000
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.
Scheme
Update
- As of October 2006, 1241 participants have been randomised in the Prevention stratum and 164 international sites are actively recruiting in the trial.
Related Publications
Cuzick J. Aromatase inhibitors for breast cancer prevention. J Clin Oncol 2005; 23: 1636–1643.
Topics
- Aromatase inhibitors
- Bisphosphonates
- Blood markers
- Predictive markers
- Bone mineral density
- Hormonal therapy
- Hormone replacement therapy
- Postmenopausal patients
- Prevention
Keywords
Prevention, breast cancer, family history, anastrozole, aromatase inhibitors, bone density
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Title
An international multi-centre study of tamoxifen versus anastrozole in postmenopausal women with ductal carcinoma in situ. IBIS-II.
BIG 05-02b
Coordinator(s)
J. Cuzick, Cancer Research UK Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Charterhouse Square, LONDON EC1M 6BQ, UNITED KINGDOM. Tel: +44 207 014 0226 Fax: +44 207 014 0269 Email: jack.cuzick@cancer.org.uk
J.F. Forbes, Department of Surgical Oncology, University of Newcastle, Newcastle Mater Misericordiae Hospital, Locked bag 7, Hunter Region Mail Centre, NSW 2310, AUSTRALIA. Tel: +61 2 4921 1155 Fax: +61 2 4929 1966 Email: john.forbes@anzbctg.newcastle.edu.au
A. Howell, CRC Medical Oncology, Christie Hospital, Wilmslow Road, Winthington, MANCHESTER M20 4BX, UNITED KINGDOM. Tel: +44 161 446 8037 Fax: +44 161 446 8000/3299 Email: maria.parker@christie-tr.nwest.nhs.uk
Summary
- Opened in Spring 2003
- Target accrual: 4000
Primary Objectives
- To determine if anastrozole is at least as effective as tamoxifen in local control and prevention of contralateral disease in women with locally excised oestrogen (ER) or progesterone (PgR) positive ductal carcinoma in situ (ER or PgR + ve DCIS).
Secondary Objectives-II
- To compare the effectiveness of tamoxifen and anastrozole according to the receptor status of the primary or recurrent cancer.
- To examine the rate of breast cancer recurrence and new contralateral tumours after cessation of tamoxifen or anastrozole.
- To examine the effect of tamoxifen versus anastrozole on breast cancer mortality.
- To examine the effect of tamoxifen and 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.
Scheme
Update
- Opened in Spring 2003. As of October 2006, 776 participants have been randomised in the DCIS stratum and 164 international sites are actively recruiting in the trial.
Related Publications
Cuzick J. Treatment of DCIS – results from clinical trials, Surgical Oncology 2003; 12: 213–219.
Topics
- DCIS
- Hormone receptor positive breast cancer
- Tamoxifen
- Tamoxifen duration
- Aromatase inhibitors
- Blood markers
- Predictive markers
- Hormonal therapy
- Hormone replacement therapy
- Postmenopausal patients
- Prevention
Keywords
Prevention, DCIS, breast cancer, family history, anastrozole, aromatase inhibitors, tamoxifen, recurrence
