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Adjuvant Breast Cancer Therapy for Premenopausal Women
Untitled Document
Name of the Trial
Phase III Randomized Study of Ovarian Function Suppression in Combination With
Tamoxifen Versus Ovarian Function Suppression in Combination With Exemestane
Versus Tamoxifen Alone in Premenopausal Women With Endocrine-Responsive Breast
Cancer (IBCSG-24-02). See the protocol
summary.
Study Chairs
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Dr. Gini Fleming
Principal Investigator |
Dr. Gini Fleming, North American Breast Intergroup; Dr. Prudence Francis, BIG.
Why Is This Trial Important?
Many women with breast cancer have tumors that grow in response to the female
hormone estrogen (endocrine-responsive tumors). The drug tamoxifen has been used to treat endocrine-responsive breast cancer in both premenopausal and postmenopausal
women.
Recently, a new class of drugs called aromatase inhibitors was shown to improve
disease-free survival in postmenopausal women with endocrine-responsive cancers.
However, aromatase inhibitors are not effective in premenopausal women because
their ovaries are still producing estrogen.
In this trial, researchers will study three groups of premenopausal women with
endocrine-responsive breast cancer. Menopause will be induced in two of the
groups; one group will be treated with tamoxifen, the other with the aromatase
inhibitor exemestane. Menopause will not be induced in the third group, which
will be treated with tamoxifen. The researchers hope to determine which treatment
approach is most effective in preventing breast cancer recurrence in premenopausal
women.
"Young women with endocrine-responsive breast cancer have a high risk
for recurrence if not treated with antihormone therapy," said Dr. Fleming.
"We are trying to explore ways to improve that therapy for these patients."
Who Can Join This Trial?
Researchers seek to enroll 3,000 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?
Study sites in the United States are recruiting patients for this trial. See
the list
of study sites.
Contact Information
See the list
of study contacts or call NCI's Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237). The toll-free call is confidential.
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