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Breast Cancer Treatment for Premenopausal Women
Untitled Document
Name of the Trial
Phase III Randomized Study of Triptorelin and Exemestane Versus Triptorelin and Tamoxifen
in Premenopausal Women With Endocrine-Responsive Breast Cancer (IBCSG-25-02). See the protocol summary.
Principal Investigators
Dr. Barbara Walley, International Breast Cancer Study Group, and Dr. Olivia Pagani,
Breast International Group.
Why Is This Trial Important?
The benefits of anti-estrogen therapy for breast cancer--in terms of reduced disease
recurrence and improved survival--have been clearly established for
postmenopausal women
whose tumors can grow in response to the female sex hormone estrogen (endocrine-responsive
breast cancer). Women who have not undergone menopause, however, may not benefit as much
from anti-estrogen therapy because their ovaries are still producing large amounts of
estrogen.
In this trial, premenopausal women with endocrine-responsive breast cancer will receive
the drug triptorelin to suppress the function of their ovaries (induction
of menopause) and
long-term anti-estrogen therapy with either exemestane (an aromatase inhibitor), to inhibit
the production of estrogen outside the ovaries, or tamoxifen, to block the growth-promoting
effects of any estrogen that might be produced. Researchers hope to determine which
anti-estrogen treatment will help premenopausal women whose ovarian function is being
suppressed survive longer without a recurrence of their cancer.
"We hope to see the same degree of benefit in this younger population that
we currently observe in older, postmenopausal women on aromatase inhibitors,"
said Dr. Walley. "With this trial and others being conducted by breast cancer
researchers, we hope also to determine the role of ovarian suppression in premenopausal
women with early stage breast cancer."
Who Can Join This Trial?
Researchers seek to enroll 1,845 premenopausal women diagnosed with breast cancer who
have had their tumors surgically removed. See the list of
eligibility criteria.
Where Is This Trial Taking Place?
Multiple study sites in the United States and elsewhere are recruiting patients for this
trial. See the list of
study sites.
Contact Information
See the list of
study contacts or call the NCI's Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237). The call is toll free and completely confidential.
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