Case Study - AZURE

Does Adjuvant Zoledronic acid redUce REcurrence in patients with high-risk, localised breast cancer?

OVERVIEW
AZURE is the largest trial to assess the effectiveness of the addition of zoledronic acid to adjuvant breast cancer therapy and is the first study of adjuvant bisphosphonates to report results with 10 years of follow-up.

CI/LEAD
Prof Robert Coleman

FUNDER(S)
Novartis

PUBLICATION
10.1016/S1470-2045(14)70302-X

The Azure trial is an academic international study designed to determine whether treatment with zoledronic acid added to standard adjuvant breast cancer therapy improves disease-free survival (DFS) and time to bone metastases.

Between September 2003 and February 2006, 3360 patients from 174 centres were randomised and followed up until 10 years.
The Azure analyses after 752 and 966 DFS events showed that, despite a reduction in the risk of developing bone metastases, there was no effect on overall breast cancer recurrence. However, a pre-planned subset analysis identified benefit in women who were in established menopause at study entry. These effects were confirmed in the EBCTCG meta-analysis of over 18,000 women and the Azure 10 year analysis which further supported the association between benefits and low levels of reproductive hormones. These exciting findings are beginning to be implemented into and change clinical practice.