Breast Cancer Treatment for Premenopausal Women
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 at http://cancer.gov/clinicaltrials/IBCSG-25-02.
Drs. Barbara Walley, International Breast Cancer Study Group, and Olivia Pagani, Breast International Group
Why Is This Trial Important?
The benefits of antiestrogen 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 antiestrogen 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 antiestrogen 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 antiestrogen 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 at http://www.cancer.gov/clinicaltrials/IBCSG-25-02.
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 at http://www.cancer.gov/clinicaltrials/IBCSG-25-02.
See the list of study contacts at http://www.cancer.gov/clinicaltrials/IBCSG-25-02, or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.
An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.