Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer

• For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer: Serious and life-threatening events associated with NOLVADEX in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial. Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for NOLVADEX vs 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for NOLVADEX vs 0.04 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for NOLVADEX vs 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for NOLVADEX versus 0.25 for placebo**.
• Some of the strokes, pulmonary emboli, and uterine malignancies were fatal.
• Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering NOLVADEX to reduce their risk of developing breast cancer.
• The benefits of NOLVADEX outweigh its risks in women already diagnosed with breast cancer.