In 1998, the drug received an expanded indication for breast cancer risk reduction in women at increased risk for this disease. There is currently insufficient evidence to determine if tamoxifen confers an overall health benefit or increases breast cancer-specific or overall survival. An Italian trial of 5,408 average-risk women who had undergone hysterectomy reported only 41 breast cancers and found no overall difference in breast cancer cases, but a reduction in risk for those women undergoing hormone replacement therapy. A British study of 2,471 women at high risk found no decline in breast cancer incidence in a population with a stronger family history of breast cancer. These risks should be taken into account when considering tamoxifen for breast cancer risk reduction.
Tamoxifen reduces fractures to a moderate degree.
There are also modest increases in bone mineral density with tamoxifen but they appear inferior to those seen with other agents indicated for use in bone preservation or osteoporosis. Despite favorable impact on cholesterol levels, tamoxifen does not appear to have beneficial effects on clinical heart disease. Raloxifene Background Raloxifene is currently FDA-approved for the prevention of osteoporosis in postmenopausal women. There are no published data on the use or toxicity profile of raloxifene in premenopausal populations. Clinical experience with raloxifene use in patients with established breast cancer is quite limited.