The NSABP Study of Tamoxifen and Raloxifene (STAR) trial

Abstract

In the Study of Tamoxifen and Raloxifene (STAR) trial, postmenopausal women at increased risk of breast cancer received either oral tamoxifen (20 mg/day) or raloxifene (60 mg/day) over 5 years. There were an equal number of cases of invasive breast cancer in women assigned to tamoxifen and raloxifene. There were fewer cases of noninvasive breast cancer in the tamoxifen group than in the raloxifene group (risk ratio [RR]: 1.40; 95% confidence interval [CI]: 0.98–2.02). There were more cases of uterine cancer with tamoxifen than with raloxifene (RR: 0.62; 95% CI: 0.35–1.08). Thromboembolic events occurred less often in the raloxifene group (RR: 0.70; 95% CI: 0.54–0.91) and there were fewer cataracts and cataract surgeries in the women taking raloxifene (RR: 0.79; 95% CI: 0.68–0.92). The STAR trial has shown that raloxifene is as effective as tamoxifen in reducing the risk of invasive breast cancer and has a lower risk of adverse events but a nonstatistically significant higher risk of noninvasive breast cancer. The risk of other cancers, fractures, ischemic heart disease and stroke is similar for both drugs.

Keywords::

• breast cancer risk reduction
• chemoprevention
• primary prevention
• raloxifene
• selective estrogen receptor modulator
• tamoxifen

Financial & competing interests disclosure

This work was supported by the Public Health Services grants, U10-CA-37377 and U10-CA-69974 from the Natrional Cancer Institute, Department of Health and Human Services. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.