AZURE

Disease site: Breast Cancer

Treatment Modality: Chemotherapy

Status: In active follow-up

It is the aim of this prospective, randomised, open label, parallel group trial to determine whether adjuvant treatment with zoledronic acid with (neo)adjuvant chemotherapy and/or (neo)adjuvant endocrine therapy is superior to (neo)adjuvant chemotherapy and/or (neo)adjuvant endocrine therapy alone in improving disease-free and bone metastasis-free survival in women with stage II/III breast cancer.  This international trial opened to recruitment in September 2003, and closed to recruitment in January 2006 with over 3,300 women randomised.  The AZURE Trial is coordinated centrally by the CTRU - University of Leeds.  ICR-CTSU acts as a local trials office for 25 sites (600 patients) and is responsible for data management, monitoring, site initiation and the day-to-day running of the trial.  Follow-up continues for the next 10 years.  AZURE is supported by the NCRI Breast Clinical Studies Group.

Chief Investigator: Professor R. Coleman, Sheffield University.

Sponsor: University of Sheffield

ISRCTN: 79831382.