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Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003906 |
RATIONALE: 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.
PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: raloxifene Drug: tamoxifen citrate |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control |
Official Title: | Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer |
Estimated Enrollment: | 19000 |
Study Start Date: | May 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind study. Participants are stratified by age (35 to 49 vs 50 to 59 vs over 59), race (black vs white vs other), history of lobular carcinoma in situ (yes vs no), prior hysterectomy (yes vs no), and estimated absolute risk of invasive breast cancer within 5 years (using the Gail model)(less than 2.0 vs 2.0-2.9 vs 3.0-4.9 vs 5.0 or greater). Participants are randomized to 1 of 2 arms.
Participants are followed annually after 5 years.
PROJECTED ACCRUAL: Approximately 19,000 participants will be accrued for this study within 5 years.
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Postmenopausal women at increased risk for developing invasive breast cancer, who meet one of the following criteria:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
No other participation in a cancer prevention or osteoporosis prevention study involving pharmacologic intervention(s)
Study Chair: | Norman Wolmark, MD | Allegheny Cancer Center at Allegheny General Hospital |
Study ID Numbers: | CDR0000067081, NSABP-P-2 |
Study First Received: | November 1, 1999 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00003906 |
Health Authority: | United States: Federal Government |
breast cancer |
Raloxifene Skin Diseases Citric Acid |
Breast Neoplasms Tamoxifen Breast Diseases |
Estrogen Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses |