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Yorkshire Breast Cancer Research Group (YBCRG)

Published online by Cambridge University Press:  04 December 2006

Abstract

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Yorkshire Breast Cancer Research Group (YBCRG). Clinical trials include:

  1. Does adjuvant zoledronic acid reduce recurrence in patients with high risk localized breast cancer? – The AZURE Trial. BIG 1-04

  2. 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.

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:

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:

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

***************************************************

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:

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:
  1. inclusion of patients with a minimum of 4 months prior Zometa treatment and a maximum of 12 months prior bisphosphonates.
  2. 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