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Video: Zometa(R) Reduces Risk of Breast Cancer Recurrence in Premenopausal Women, Study in The New England Journal of Medicine Reports
Date:2/11/2009

e a significant reduction in risk of recurrence in these patients from a therapy that was also well-tolerated," said David Epstein, President and CEO of Novartis Oncology. "The findings of this landmark trial substantiate the strong anticancer effect of Zometa beyond the well-established benefit of this treatment in preventing bone complications in advanced cancers."

The ABCSG Trial 12 (ABCSG-12) included more than 1,800 premenopausal women with early-stage breast cancer who, following curative surgery and goserelin treatment to suppress the ovaries, were treated with hormone therapy with or without Zometa for three years. The results demonstrated that the addition of Zometa to hormone therapy (tamoxifen or anastrozole) significantly prolonged both disease-free survival and recurrence-free survival.

Study details

ABCSG-12 is an open-label, multicenter, Phase III study that enrolled 1,803 premenopausal women with estrogen receptor-positive Stage I or II breast cancer, with fewer than 10 axillary lymph nodes involved. Patients were recruited for the study after curative surgery and initiation of goserelin treatment for ovarian suppression, and randomly assigned into one of four study groups: (1) anastrozole plus Zometa; (2) anastrozole alone; (3) tamoxifen plus Zometa; (4) tamoxifen alone. The treatment period was three years and the median follow-up period was 48 months(2).

The primary endpoint for all four study arms was disease-free survival. Recurrence-free survival, overall survival and bone-mineral density were secondary endpoints. Disease-free survival was defined as the length of time after randomization during which patients had no local recurrence, contralateral breast cancer, distant metastasis, secondary carcinoma and/or death from any cause. Recurrence-free survival was defined as the length of time after randomization during which patients had no local recurrence, contralateral breast canc
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SOURCE Novartis Pharmaceuticals Corporation
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