Questions About Cancer? 1-800-4-CANCER

Featured Clinical Trials

Cancer Studies Highlighted in the NCI Cancer Bulletin
  • Posted: 10/11/2005
  • Updated: 04/08/2010

Adjuvant Breast Cancer Therapy for Premenopausal Women

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 1.

Study Chairs

Dr. Gini Fleming
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."

For More Information

See the lists of entry criteria 2 and trial contact information 3 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.

Related Pages



Glossary Terms

aromatase inhibitor (uh-ROH-muh-tays in-HIH-bih-ter)
A drug that prevents the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy for postmenopausal women who have hormone-dependent breast cancer.
estrogen (ES-truh-jin)
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.
exemestane (EK-seh-MEH-stayn)
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.
tamoxifen (tuh-MOK-sih-FEN)
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.

Table of Links

1http://cancer.gov/clinicaltrials/NCT00066690
2http://www.cancer.gov/clinicaltrials/NCT00066690#EntryCriteria_CDR0000316456
3http://www.cancer.gov/clinicaltrials/NCT00066690#ContactInfo_CDR0000316456
4http://www.cancer.gov/clinicaltrials/search
5http://www.cancer.gov/cancertopics/types/breast