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Does adjuvant zoledronic acid reduce recurrence in patients with high risk localised breast cancer?

Disease site: Breast cancer

Treatment modality: Systemic therapy

Status: In follow up

Trial details

AZURE is a 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.

AZURE is co-ordinated centrally by the Clinical Trials Research Unit at the University of Leeds. ICR-CTSU acted as a local trials office for 25 sites (600 patients) during the interventional phase of the trial.

Further information

Chief Investigator: Professor Robert Coleman, Sheffield University

ISRCTN: 79831382

Sponsor: University of Sheffield

View AZURE on the National Institute for Health Research website: NIHR - Be Part Of Research

Patient friendly information is available from the following link:

UK CancerHelp

Publications and presentations

Coleman RE, Marshall H, Cameron D, Dodwell D, Burkinshaw R, Keane M, Gil M, Houston SJ, Grieve RJ, Barrett-Lee PJ, Ritchie D, Pugh J, Gaunt C, Rea U, Peterson J, Davies C, Hiley V, Gregory W, Bell R; AZURE Investigators. Breast cancer adjuvant therapy with zoledronic acid. N Engl J Med. 2011; 365(15): 1396-405.

Coleman R, Woodward E, Brown J, Cameron D, Bell R, Dodwell D, Keane M, Gil M, Davies C, Burkinshaw R, Houston SJ, Grieve RJ, Barrett-Lee PJ, Thorpe H. Safety of zoledronic acid and incidence of osteonecrosis of the jaw (ONJ) during adjuvant therapy in a randomised phase III trial (AZURE: BIG 01-04) for women with stage II/III breast cancer. Breast Cancer Res Treat. 2011; 127(2): 429-38.

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.