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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 Exemestane Versus Adjuvant Tamoxifen in Postmenopausal Women With Early Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Any age	Other	CRC-TU-TEAM EU-20149, ISRCTN75225940, NCT00032136

Trial Description

Purpose:

Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known if exemestane is more effective than tamoxifen in preventing the recurrence of breast cancer.

Randomized phase III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have undergone surgery to remove early-stage breast cancer.

Eligibility:

Eligibility criteria include the following:

• Any age
• No more than 10 weeks since surgery or chemotherapy
• 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 two groups. Patients in group one will receive tamoxifen by mouth once a day for at least 5 years. Patients in group two will receive exemestane by mouth once a day for at least 5 years. Quality of life will be assessed periodically for 1 year. Patients will be evaluated at least 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

Cancer Research UK Clinical Trials Unit - Birmingham

Daniel Rea, MD, Protocol chair		Ph: 44-121-507-5241

Registry Information
Official Title		An Open Label, Randomized Multicenter Comparative Trial Of 5 Years Adjuvant Exemestane Treatment Versus 5 Years Adjuvant Tamoxifen Treatment In Postmenopausal Women With Early Breast Cancer
Trial Start Date		2001-12-05
Registered in ClinicalTrials.gov		NCT00032136
Date Submitted to PDQ		2002-01-23
Information Last Verified		2007-03-27

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