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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 ³.

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 ⁴.

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 ⁵.

Contact Information

See the list of study contacts ⁵ 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.

Glossary Terms

A type of hormone made by the body that helps develop and maintain female sex characteristics and the growth of long bones. Estrogens can also be made in the laboratory. They may be used as a type of birth control and to treat symptoms of menopause, menstrual disorders, osteoporosis, and other conditions.

A drug used to treat advanced breast cancer and to prevent recurrent breast cancer in postmenopausal women who have already been treated with tamoxifen. It is also being studied in the treatment of other types of cancer. Exemestane causes a decrease in the amount of estrogen made by the body. It is a type of aromatase inhibitor. Also called Aromasin.

The time of life when a woman’s ovaries stop producing hormones and menstrual periods stop. Natural menopause usually occurs around age 50. A woman is said to be in menopause when she hasn’t had a period for 12 months in a row. Symptoms of menopause include hot flashes, mood swings, night sweats, vaginal dryness, trouble concentrating, and infertility.

Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrent cancer.

A drug used to treat certain types of breast cancer in women and men. It is also used to prevent breast cancer in women who have had ductal carcinoma in situ (abnormal cells in the ducts of the breast) and in women who are at a high risk of developing breast cancer. Tamoxifen is also being studied in the treatment of other types of cancer. It blocks the effects of the hormone estrogen in the breast. Tamoxifen is a type of antiestrogen. Also called tamoxifen citrate.

A drug that is used to treat advanced prostate cancer, and is being studied in the treatment of breast cancer. It belongs to the family of hormonal drugs called gonadotropin-releasing hormone analogs. Also called Trelstar.