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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Adjuvant Letrozole Versus Tamoxifen in Postmenopausal Women With Operable, Hormone Receptor-Positive Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	30 and over	Pharmaceutical / Industry	IBCSG-1-98 DAN-DBCG-IBCSG-1-98, FRE-FNCLCC-IBCSG-1-98, EU-99022, IBCSG-18-98, NOVARTIS-2026703019, NCT00004205, BIG-I-98

Trial Description

Purpose:

Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. If is not yet known which treatment regimen is most effective for breast cancer.

Randomized double-blind phase III trial to compare the effectiveness of letrozole with that of tamoxifen in treating postmenopausal women who have breast cancer that has been surgically removed.

Eligibility:

• At least 30 years old
• No distant metastases
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of four groups. Patients in group one will receive tamoxifen by mouth once a day for 5 years. Patients in group two will receive letrozole by mouth once a day for 5 years. Patients in group three will receive tamoxifen by mouth once a day for 2 years followed by letrozole by mouth once a day for 3 years. Patients in group four will receive letrozole by mouth once a day for 2 years followed by tamoxifen by mouth once a day for 3 years. Patients may receive radiation therapy. Some patients may also receive chemotherapy beginning within 8 weeks following surgery and continuing for up to 6 months. Patients will receive follow-up evaluations once a year.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

International Breast Cancer Study Group

Beat Thurlimann, MD, Protocol chair		Ph: 41-71-494-1888 Email: beat.thuerlimann@kssg.ch

Federation Nationale des Centres de Lutte Contre le Cancer

Louis Mauriac, MD, Protocol chair		Ph: 33-56-333-258 Email: mauriac@bergonie.org

Danish Breast Cancer Cooperative Group

Henning Mouridsen, MD, PhD, Protocol chair		Ph: 45-3545-8500 Email: hmouridsen@rh.dk

Registry Information
Official Title		A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women with Receptor (ER and/or PgR) Positive Tumors
Trial Start Date		1998-03-18
Registered in ClinicalTrials.gov		NCT00004205
Date Submitted to PDQ		1999-12-02
Information Last Verified		2001-03-14