TAMOXIPLEX is effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, TAMOXIPLEX is an alternative to oophorectomy or ovarian irradiation . Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from TAMOXIPLEX therapy .
Adjuvant Treatment of Breast Cancer
TAMOXIPLEX is indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection , and breast irradiation. In some TAMOXIPLEX adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes.
TAMOXIPLEX is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection , and breast irradiation.
The estrogen and progesterone receptor values may help to predict whether adjuvant TAMOXIPLEX therapy is likely to be beneficial.
TAMOXIPLEX reduces the occurrence of contralateral breast cancer in patients receiving adjuvant TAMOXIPLEX therapy for breast cancer.
Ductal Carcinoma in Situ ( DCIS )
In women with DCIS, following breast surgery and radiation , TAMOXIPLEX is indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with TAMOXIPLEX for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of TAMOXIPLEX therapy.
Current data from clinical trials support five years of adjuvant TAMOXIPLEX therapy for patients with breast cancer.
Reduction in Breast Cancer Incidence in High Risk Women
TAMOXIPLEX is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality
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