More Women Needed to Volunteer for Breast Cancer Prevention Study

(press release from Cancer Research UK, october 12th, 2009)

Volunteers from Europe and Australia are needed to take part in an international study on breast cancer prevention led by world-leading charity Cancer Research UK.

5,000 women have already been recruited to IBIS II which is the only trial worldwide to investigate whether a drug called anastrozole can prevent breast cancer in postmenopausal women who are at increased risk of the disease.

But more are needed.

Professor Jack Cuzick, joint IBIS II chairman, told delegates at the National Cancer Research Institute’s annual conference in Birmingham that it is vital for more volunteers to come forward.

Previous research on anastrozole as a treatment for early breast cancer suggested that it could prevent up to 70 percent of new tumours occurring but a large study must be conducted to confirm its role in preventing the disease in women at increased risk.

Prof Cuzick, who is based at Cancer Research UK’s centre for Epidemiology, Mathematics and Statistics, Queen Mary University in London, said: “It is gratifying that so many women have come forward to take part in IBIS-II as this study could provide them and future generations with a valuable approach to prevent what is now the commonest cancer in women,” he said.

“But we need even more women to come forward if we are to learn whether new hormone treatments like anastrozole can not only treat breast cancer successfully but also prevent menopausal women at high risk from developing the disease.”

The study has been running since 2003 with women from 15 countries participating. These are Australia, Austria, Belgium, Denmark, Germany, Finland, France, Hungary, Ireland, Italy, Malta, Portugal, Switzerland, Turkey and the UK.

Mrs Sue Holloway, from Leeds (UK) was the first woman to join the IBIS-II study in February 2003. “My mother developed breast cancer at age 29 and she battled it for 15 years before dying at age 44. Seeing how devastating breast cancer had been for my mother prompted me to join the IBIS-II study. If I could be part of trying to prevent this disease I wanted to be.”

Mrs Holloway, 46, who completed the study in February 2008 says that her mother’s death shaped her outlook on life. “I think that if you don’t try you don’t succeed. By joining the study I felt like I was helping further research into breast cancer as well as protecting myself as much as possible. It’s about putting all the pieces of the jigsaw together and hopefully we will find out how we can halt this disease.”

The study is open to women aged 40-70 years who have passed the menopause and are at increased risk of breast cancer, due to a family history or other risk factors such as breast density or benign breast disease.

More than 1.2 million women in the world are diagnosed with breast cancer every year. Improvements have been made in recent years in the treatment of breast cancer, and more cancers are being diagnosed early through national screening programmes. But scientists still need to know more about how to prevent breast cancer.

More information is also available on the IBIS-II website www.ibis-trials.org. Women can find out more about whether they are eligible to take part in the study by calling:

For media enquiries or to interview an IBIS-II spokesperson or participant on the study please contact Nicola Brebner on 0207 882 3512.

Notes to editors

IBIS-II is being supported by Cancer Research UK and sponsored by Queen Mary, University of London.

· The International Breast Cancer Intervention Study II has been designed to investigate the breast cancer treatment drug, anastrozole, in women who are at an increased risk of breast cancer.

· The study is currently recruiting women.

· The IBIS-II study is a randomised, blinded placebo controlled Phase 3 clinical study.

· The study is divided into two parts:

o The IBIS-II Prevention part of the study aims to recruit 6,000 post-menopausal women who are at increased risk of developing breast cancer. A number of factors for increased risk can make a woman eligible to enter the study and these are set according to the different age groups. Women can take part in the study if they are aged between 40-70 years and are not on HRT. Women who have had breast cancer cannot enter this part of the study.

o The second part of the study, IBIS-II DCIS is recruiting 4,000 women who have been diagnosed with and had surgery to remove a particular early form of breast cancer, which is not growing or spreading, known as DCIS (Ductal carcinoma in situ). As well as being at high risk of developing more advanced forms of breast cancer, these women are also more likely to develop a new tumour in the opposite breast. This part of the study is designed to determine which of the two drugs, anastrozole or tamoxifen, can best prevent new cancers, both in the breast affected by DCIS and in the opposite breast.

2 Anastrozole (trade name Arimidex)

· Anastrozole is one of a group of drugs called aromatase inhibitors. In post-menopausal women, an enzyme called aromatase is the main source of oestrogen. Aromatase inhibitors block the action of aromatase, reducing the levels of oestrogen in the body.

· In the UK, anastrozole is approved for use in the adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer.

· Anastrozole is known to have some side effects which include hot flushes, vaginal dryness, hair thinning, joint pains and an increased risk of osteoporosis (weakened bones).

Country

No. recruited

Contact Name

Contact telephone

Contact Email

Australia

579

Linda Hunter

00 61 2 4985 0120

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Austria

Barbara Schaljo-kapp

00 43 1 408 92 30-22

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Belgium

140

Daisy Supply

00 32 16 347587

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Denmark

Dr Charlotte Lanng

00 45 4488 4000 ext 89265

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Germany

656

Dr Silvia Gimeno

00 49 6102 798 7435

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Finland

132

Riita Toivonen

00 358 324 99600

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France

372

Anne-Laure Martin

00 33 1 44 23 55 56

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Hungary

Dr. Zsuzsanna Kahan

00 36 62 546 122

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Ireland

102

Nicola Brebner

00 44 207 882 3512

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Italy

424

Aliana Guerrieri

00 39 0257 489 893

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Malta

Nadia Cilia

00 356 22987143

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Portugal

Conceição Costa

00 351 21 722 98 92

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2182

Nicola Brebner

00 44 207 882 3512

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Switzerland

Bettina Cliffe

00 41 31 389 92 72

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Turkey

Aysun Ozdere

00 90 312 427 53 14

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*The following countries have recruited women (100) however they are no longer recruiting, but continue to do follow-ups.

Chile, Egypt, India, Pakistan, Peru.

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