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

Alternate Title

Phase III Randomized Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Prevention	Closed	35 and over	NCI	NSABP-P-2 NCT00003906

Trial Description

Purpose:

Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.

Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.

Eligibility:

• At least 35 years old
• No more than 1 year since undergoing mammography with no evidence of cancer
• No previous mastectomy to prevent breast cancer
• No previous invasive breast cancer or intraductal carcinoma in situ
• At least 3 months since hormone therapy
• No previous radiation therapy to the breast
• 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:

Participants will be randomly assigned to one of two groups. Participants in group one will receive tamoxifen plus a placebo by mouth once a day. Participants in group two will receive raloxifene plus a placebo by mouth once a day. Treatment may continue for 5 years. Quality of life will be assessed at the beginning of the study and then every 6 months for 5 years. Participants will be evaluated 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

National Surgical Adjuvant Breast and Bowel Project

Norman Wolmark, MD, Protocol chair		Ph: 412-359-3336; 866-680-0004

Related Information

Web site for additional information

Registry Information
Official Title		Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer
Trial Start Date		1999-05-26
Registered in ClinicalTrials.gov		NCT00003906
Date Submitted to PDQ		1999-05-26
Information Last Verified		2006-06-07
NCI Grant/Contract Number		CA12027