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Study of Tamoxifen and Raloxifene (STAR) Trial
    Posted: 07/27/2000    Updated: 09/12/2007



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NCI's gateway for information about breast cancer.

U.S. Task Force: Chemoprevention of Breast Cancer
The U.S. Preventive Services Task Force has issued two recommendations concerning the use of prescription medicines such as tamoxifen in the prevention of breast cancer.

Estrogen Receptors, Tamoxifen, and Raloxifene
Describes the hormone estrogen and its receptor. Explains the relationship of estrogen and its receptor to breast cancer and the risks and benefits of reducing cancer risk with drugs called antiestrogens and selective estrogen receptor molecules (SERMs).
STAR-At-A Glance

Main Objective STAR was designed to determine whether the osteoporosis drug raloxifene is as effective in reducing breast cancer risk as tamoxifen, with fewer side effects.
Enrollment Accrual Period July 1999 – November 2004
Participants A total of 19,737 women:
  • 93.4% white
  • 2.5% African American
  • 2.0% Hispanic/Latina
  • 2.1% other minorities
Intervention Women were randomly assigned to take either 20 mg of tamoxifen and a placebo or 60 mg raloxifene and a placebo daily for five years.
Criteria for Participation
  • General good health
  • 35 and over
  • Women
  • Postmenopausal at high risk for breast cancer based on the Gail risk model
Study Sites More than 500 in the U.S., Puerto Rico and Canada.
Additional Study Objectives Investigators are assessing rates of invasive breast cancer, noninvasive breast cancer, uterine cancer, deep vein thrombosis, pulmonary embolism, bone fractures, stroke, cataracts, ischemic heard disease, all other cancers, and overall deaths. Quality of life factors (including hot flashes, which both drugs can trigger) and cognitive function in older women are also being examined.

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