Zometa Fails to Reduce Recurrence of Early Breast Cancer
Among women with early breast cancer, adjuvant (post-surgery) use of the bisphosphonate drug Zometa® (zoledronic acid) did not reduce the risk of cancer recurrence. These results—from the Phase III AZURE study—were presented at the 2010 San Antonio Breast Cancer Symposium.
Zometa is a bisphosphonate drug that is used for the treatment of cancer-related hypercalcemia (high levels of calcium in the blood) and to reduce bone complications from multiple myeloma or bone metastases. Some research has suggested that Zometa may also have anticancer effects. In 2009, for example, results from a Phase III clinical trial conducted by the Austrian Breast and Colorectal Cancer Study Group indicated that Zometa may reduce the risk of cancer recurrence among women with early, hormone receptor-positive breast cancer. The women in this study were initially premenopausal, but were treated with goserelin to suppress ovarian hormone production and induce menopause.
The current Phase III clinical trial is an international study known as AZURE (__A__djuvant __Z__oledronic acid to red__U__ce __RE__currence). The study enrolled 3,360 women with Stage II or Stage III breast cancer. Study participants received standard cancer treatment alone or in combination with Zometa.
- Overall, Zometa did not improve disease-free survival.
- In the subset of women who were at least five years beyond menopause, Zometa improved overall survival by 29%.
- Treatment with Zometa carried a small risk of osteonecrosis of the jaw (death of bone in the jaw).
These results do not support the routine use of Zometa to improve cancer outcomes among women with early-stage breast cancer. The possibility that Zometa may benefit postmenopausal women with early breast cancer warrants additional research.
 Gnant M, Mlineritsch B, Schippinger W, et al. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. New England Journal of Medicine. 2009;360:679-691.
 Coleman RE, Thorpe HC, Cameron D et al. Adjuvant treatment with Zoledronic Acid in stage II/II breast cancer. The AZURE Trial (BIG 01/04). Presented at the 33rd annual San Antonio Breast Cancer Symposium, December 8-12, 2010. Abstract S4-5.
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