YBCRG – Contact Details
Country
England
Chair
Mr M. Lansdown, Consultant in General Surgery, St James‘s University Hospital, Beckett St., Leeds LS9 7TF, WEST YORKSHIRE, UNITED KINGDOM. Tel: +44 113 206 4506 Fax: +44 113 268 1340 Email: mark.lansdown@leedsth.nhs.uk
Biostatistics Unit
Clinical Trials Research Unit, 17 Springfield Mount, Leeds LS2 9NG, WEST YORKSHIRE, UNITED KINGDOM. Tel: +44 113 343 1477 Fax: +44 113 343 1471
Study Center
Clinical Trials Research Unit, 17 Springfield Mount, Leeds LS2 9NG, WEST YORKSHIRE, UNITED KINGDOM. Tel: +44 113 343 1477 Fax: +44 113 343 1471
YBCRG – Study Details
Title
Does adjuvant zoledronic acid reduce recurrence in patients with high risk localized breast cancer? – The AZURE Trial.
BIG 1-04
Coordinator(s)
Mrs Samantha Beevers, Trial Co-ordinator, Clinical Trials Research Unit, 17 Springfield Mount, Leeds LS2 9NG, WEST YORKSHIRE, UNITED KINGDOM. Tel: +44 113 343 7684 Fax: +44 113 343 1471 Email: s.j.beevers@leeds.ac.uk
Summary
- Recruitment closed in January 2006
- Total of 3360 patients recruited
Objective
- It is the aim of this prospective, randomized, open label, parallel group trial to determine whether adjuvant treatment with 4mg zoledronic acid with (neo)adjuvant chemotherapy and/or adjuvant hormonal therapy is superior to (neo)adjuvant chemotherapy and/or adjuvant hormonal therapy alone in improving the disease-free and bone metastasis-free survival of stage II/III breast cancer patients.
Scheme
Update
- The AZURE trial closed to recruitment on the 20th January 2006, having reached target recruitment 8 months ahead of schedule. A total of 3360 patients have been recruited from 174 sites internationally including sites in Spain, Portugal, Ireland, Australia, Thailand and Taiwan.
Related Publications
No publications as yet.
Topics
- Bisphosphonates
- Locally advanced breast cancer
- Node positive breast cancer
Keywords
Zoledronic Acid, high risk, localized breast cancer, adjuvant, bisphosphonates
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Title
Cost-effective use of BISphosphonates in metastatic bone disease:
A comparison of bone MARKer directed zoledronic acid therapy to a standard schedule – The BISMARK Trial.
Coordinator(s)
Liz Graham / Clarie Caffrey, Clinical Trials Research Unit, University of Leeds, 17 Springfield Mount, Leeds LS2 9NG, WEST YORKSHIRE, UNITED KINGDOM. Tel: +44 113 343 1498 / +44 113 343 8089 Fax: +44 113 343 1487 Email: e.h.graham@leeds.ac.uk c.l.caffrey@leeds.ac.uk
Summary
- It is the aim of this trial to determine whether a bone marker directed schedule of bisphosphonate therapy is comparable with a fixed 3–4 weekly strategy in preventing skeletal related events and maintaining quality of life.
Primary Objective
- To compare the frequency and timing of all SREs. These are defined as fractures, radiotherapy to bone, hypercalcaemia of malignancy, orthopaedic surgery and spinal cord compression.
Secondary Objectives
To compare:
- Quality of life (QoL).
- Clinical burden of skeletal complications.
- Pain, performance status and analgesic use (PPA score).
- The incidence of new bone metastases.
- Overall survival.
- Bisphosphonate use and expenditure on administration.
Sub-studies in a sub-set of the study population will compare:
- Health care utilisation.
- Evaluation of the clinical utility of the “point of care” test for Ntx excretion.
- Changes in serum markers of bone metabolism.
The trial recruited its first patient in March 2006 and aims to recruit 1500 patients over a 2–3 year period.
Scheme
Update
- 21 centres are open to recruitment, 49 patients have been randomised to date (6 October 2006). Protocol version 3.0 was approved at the end of September 2006. Major changes are:
- inclusion of patients with a minimum of 4 months prior Zometa treatment and a maximum of 12 months prior bisphosphonates.
- Novartis support for the trial, including investigator payments.
Related Publications
None available
Topics
- Bisphosphonates
- Blood markers
- Metastatic breast cancer
- Predictive markers
- Prognostic factors
Keywords
Bisphosphonates, urinary Ntx, bone markers, metastatic breast cancer
