Trial shows new drug does not improve survival rates in breast cancer patients
The AZURE* trial, which was led by Professor Rob Coleman from the University of Sheffield and Sheffield Teaching Hospitals and coordinated by the Clinical Trials Research Unit (CTRU) at the University of Leeds, tested patients with stage II/III breast cancer.
The AZURE trial, which was funded by Weston Park Hospital Cancer Charity, included 3,360 patients from 174 centres. Professor Coleman and colleagues randomly assigned the patients to standard therapy or to standard therapy plus zoledronic acid. The primary outcome was disease free survival and the researchers found no difference in disease free survival in the overall population.
Whilst the ultimate findings were negative in the larger population of participants some benefits were seen in post-menopausal women. 1101 patients were five years post-menopause, which accounted for 30 percent of the overall group. Out of these participants there was a 29 percent improvement in overall survival. Whilst these findings are significant, they are also a secondary outcome of the trial meaning that further study will be required.
Professor Coleman said: “In the larger population, we did not see a difference but in the post-menopausal women a survival advantage like this is quite remarkable, and the difference in outcome between this group and the younger population is unlikely to be a chance finding. We will clearly want to investigate further in this population.”
The findings were presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium yesterday (9 December 2010).
Notes for Editors: *The AZURE trial: Adjuvant Treatment with Zoledronic Acid in Stage II/III Breast Cancer.
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