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Landmark
breast cancer prevention study launches in Canada and the
United States — ExCel Research Study Seeks 4,500 Women to
Participate in Clinical Trial
30 March 2005
TORONTO - A major clinical trial looking at a new way to
prevent breast cancer has been launched today in Canada
and the United States.
Coordinated by the National Cancer Institute of Canada Clinical
Trials Group (NCIC CTG), and funded in part by the Canadian
Cancer Society, the ExCel research study will test whether
the drug exemestane can help prevent breast cancer in women
who are at increased risk for the disease. Exemestane —
a member of a class of drugs called aromatase inhibitors
— suppresses estrogen production, a key component in the
development of some types of breast cancer. Pfizer manufactures
exemestane and is also supporting the study and providing
the drug for the trial.
“Breast cancer is a major public health issue. Every 30
seconds somewhere in the world a woman is diagnosed with
this disease,” says Dr. Paul Goss, the ExCel research study
chair. “Recent research on aromatase inhibitors is already
helping many women reduce their risk of breast cancer recurrence.
We therefore think this could be an effective approach to
preventing it from developing in the first place.”
Initial results of the trial could be available within four
years and study investigators hope to see as much as a two-thirds
reduction in the incidence of breast cancer among the women
taking exemestane, adds Dr. Goss.
The ExCel research study will follow more than 4,500 postmenopausal
women from Canada, the United States and Spain over a five-year
period. To be eligible, women must be 35 years of age or
older and have an increased risk of developing breast cancer.
Risk factors can include a woman’s age, her family history
of breast cancer, her age at first menstrual period and
her age at her first child’s birth.
The trial design includes a quality of life component and
a number of sub-studies are also planned that will evaluate
topics such as the impact of physical activity on reducing
breast cancer risk, as well as cognitive function and bone
density of women during menopause.
Aromatase inhibitors are currently being used to treat breast
cancer recurrence in women around the world. Results from
a study published in a March 2004 issue of the New England
Journal of Medicine demonstrated that exemestane was able
to prevent the occurrence of new cancers in the opposite
breast of women who have already had breast cancer, suggesting
that it may also be able to prevent the disease in healthy
women.
Clinical studies have also shown that aromatase inhibitors
are associated with fewer serious side effects than tamoxifen,
the only other drug available to women for the primary prevention
of breast cancer.
“While tamoxifen has already been shown to reduce the incidence
of primary breast cancer, many women choose not to take
this drug because of its known side effects,” says Dr. Goss,
also the Director of Breast Cancer Research at the Massachusetts
General Hospital and Professor of Medicine at Harvard Medical
School. “Results of this study will provide women with important
information about another potential tool for breast cancer
prevention that could offer greater benefits and with fewer
side effects.”
Dr. Barbara Whylie, CEO of the Canadian Cancer Society,
says, “Research already suggests that diet and exercise
may be effective ways women can reduce their risk of breast
cancer – a disease we know takes a tremendous toll on Canadian
women and their families. We’re looking forward to the results
of this research and the possibility of providing women
with another option for breast cancer prevention.”
Breast cancer is the most commonly diagnosed cancer and
the second most common cause of cancer death in Canadian
women. An estimated 21,200 women were diagnosed with breast
cancer in Canada in 2004. An estimated 5,200 women died
in Canada last year from the disease.
The National Cancer Institute of Canada Clinical Trials
Group, based at Queen’s University in Kingston, Ontario
and funded by the Canadian Cancer Society, is working in
cooperation with physicians in Canada, the United States
and Spain to coordinate the ExCel research study. Founded
in 1971, the NCIC CTG develops, conducts and analyzes national
and international trials of cancer therapy, including trials
for new cancer drugs, cancer prevention and supportive care
to improve quality of life for people with cancer. Since
its inception, the NCIC CTG has enrolled more than 40,000
patients from Canada and around the world in over 300 clinical
trials.
Women looking for more information about the ExCel research
study and participating study centres in their community
can visit www.excelstudy.com or call toll-free:
• In Canada, the Canadian Cancer Society’s Cancer Information
Service: 1 888 939-3333
• In the U.S., the National Cancer Institute’s Cancer Information
Service: 1-800-4-CANCER
About Exemestane
Exemestane belongs to a class of drugs called aromatase
inhibitors. Aromatase inhibitors prevent the conversion
of androgens to estrogen, which is the primary source of
estrogen production in postmenopausal women. Estrogen contributes
to breast cancer growth in most women and inhibition of
estrogen can inhibit growth of breast cancer in many women.
Exemestane was approved by Health Canada in 2000 and by
the U.S. Food and Drug Adminstration in 1999 for the treatment
of advanced breast cancer in postmenopausal women whose
tumors have stopped responding to tamoxifen therapy. It
is marketed by Pfizer, Inc. as Aromasin® and also approved
for use in Europe, Japan, and South America.
The Canadian Cancer Society is a national community-based
organization of volunteers whose mission is to eradicate
cancer and to enhance the quality of life of people living
with cancer. When you want to know more about cancer, visit
our website www.cancer.ca or call our toll-free, bilingual
Cancer Information Service at 1 888 939-3333.
-30-
For more information, please contact:
Carmen Kinnibugh
Communications
Canadian Cancer Society
Phone: (416) 934-5684
Rachel Brown
French media contact
Canadian Cancer Society Canadian Cancer Society
Phone: (416) 934-5681
http://www.cancer.ca/
ccs/internet/mediareleaselist/
0,,3543_434465_390965567_langId-en.html
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