| 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. |
