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Spots Global Cancer Trial Database for Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer

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Trial Identification

Brief Title: Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer

Official Title: Zoledronate Versus Ibandronate Comparative Evaluation: A Randomized Phase III, Open-Label, Multicenter, Parallel Group Clinical Trial to Evaluate and Compare the Efficacy, Safety Profile and Tolerability of Oral Ibandronate Versus Intravenous Zoledronate in the Treatment of Breast Cancer Patients With Bone Metastases

Study ID: NCT00326820

Study Description

Brief Summary: RATIONALE: Ibandronate and zoledronate may help relieve some of the symptoms caused by bone metastases. It is not yet know whether ibandronate is more effective than zoledronate in treating bone metastases from breast cancer. PURPOSE: This randomized phase III trial is studying ibandronate to see how well it works compared with zoledronate in treating patients with newly diagnosed bone metastases from breast cancer.

Detailed Description: OBJECTIVES: Primary * Compare the efficacy, in terms of reducing frequency and timing of skeletal-related events (SREs), of ibandronate vs zoledronate in patients with newly diagnosed bone metastases secondary to breast cancer. Secondary * Compare the median time to first SRE in patients treated with these regimens. * Compare the percentage of patients experiencing a SRE after treatment with these regimens. * Compare the number of occult vertebral fractures present in patients at the end of treatment with these regimens. * Compare the pain and analgesic scores and quality of life of patients treated with these regimens. * Compare the number of patients developing renal dysfunction or hypocalcemia during the study period. * Compare the number of patients developing osteonecrosis of the jaw during study treatment and follow-up. * Compare the overall survival of these patients at 96 weeks and at 5 years. * Compare the health-resource usage of patients treated with these regimens. OUTLINE: This is a randomized, open-label, parallel-group, controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive zoledronate IV over 15 minutes on day 1. Treatment repeats every 21\* or 28 days for at least 96 weeks (24 or 32 courses) in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients who receive concurrent chemotherapy every 3 weeks receive study treatment every 21 days * Arm II: Patients receive oral ibandronate once daily on days 1-28. Treatment repeats every 28 days for at least 96 weeks (24 courses) in the absence of disease progression or unacceptable toxicity. Patients with bone pain or hypercalcemia at study entry or those who require IV therapy due to hypercalcemia while on study may receive 1 treatment with ibandronate IV at the discretion of the supervising clinician. Quality of life and pain are assessed at baseline, after every 3 courses, and at completion of study treatment. After completion of study treatment, patients are followed annually for up to 3 years. PROJECTED ACCRUAL: A total of 1,400 patients will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

William Harvey Hospital, Ashford, England, United Kingdom

North Devon District Hospital, Barnstaple, England, United Kingdom

Royal Bournemouth Hospital, Bournemouth, England, United Kingdom

Burnley General Hospital, Burnley, England, United Kingdom

Queen's Hospital, Burton-upon-Trent, England, United Kingdom

Kent and Canterbury Hospital, Canterbury, England, United Kingdom

Broomfield Hospital, Chelmsford, Essex, England, United Kingdom

Gloucestershire Oncology Centre at Cheltenham General Hospital, Cheltenham, England, United Kingdom

Countess of Chester Hospital, Chester, England, United Kingdom

Essex County Hospital, Colchester, England, United Kingdom

Walsgrave Hospital, Coventry, England, United Kingdom

Darent Valley Hospital, Dartford Kent, England, United Kingdom

Derbyshire Royal Infirmary, Derby, England, United Kingdom

Dorset County Hospital, Dorchester, England, United Kingdom

University Hospital of North Durham, Durham, England, United Kingdom

Royal Devon and Exeter Hospital, Exeter, England, United Kingdom

Queen Elizabeth Hospital, Gateshead, England, United Kingdom

Diana Princess of Wales Hospital, Grimsby, England, United Kingdom

Calderdale Royal Hospital, Halifax, England, United Kingdom

University Hospital of Hartlepool, Hartlepool, Cleveland, England, United Kingdom

Wycombe General Hospital, High Wycombe, England, United Kingdom

Huddersfield Royal Infirmary, Huddersfield, West Yorks, England, United Kingdom

Princess Royal Hospital at Hull and East Yorkshire NHS Trust, Hull, England, United Kingdom

Ipswich Hospital, Ipswich, England, United Kingdom

Royal Liverpool University Hospital, Liverpool, England, United Kingdom

Whipps Cross Hospital, London, England, United Kingdom

Saint Bartholomew's Hospital, London, England, United Kingdom

St. George's Hospital, London, England, United Kingdom

Royal Marsden - London, London, England, United Kingdom

Charing Cross Hospital, London, England, United Kingdom

Macclesfield District General Hospital, Macclesfield, England, United Kingdom

Maidstone Hospital, Maidstone, England, United Kingdom

Queen Elizabeth The Queen Mother Hospital, Margate, England, United Kingdom

St. Mary's Hospital, Newport, England, United Kingdom

King's Mills Hospital, Nottinghamshire, England, United Kingdom

Nottingham City Hospital, Nottingham, England, United Kingdom

George Eliot Hospital, Nuneaton, England, United Kingdom

Peterborough Hospitals Trust, Peterborough, England, United Kingdom

Dorset Cancer Centre, Poole Dorset, England, United Kingdom

Portsmouth Oncology Centre at Saint Mary's Hospital, Portsmouth, England, United Kingdom

Rosemere Cancer Centre at Royal Preston Hospital, Preston, England, United Kingdom

Alexandra Healthcare NHS, Redditch, Worcestershire, England, United Kingdom

Conquest Hospital, Saint Leonards-on-Sea, England, United Kingdom

Scarborough General Hospital, Scarborough, England, United Kingdom

Scunthorpe General Hospital, Scunthorpe, England, United Kingdom

Wexham Park Hospital, Slough, Berkshire, England, United Kingdom

Solihull Hospital, Solihull, England, United Kingdom

Southampton General Hospital, Southampton, England, United Kingdom

University Hospital of North Tees, Stockton-On-Tees, England, United Kingdom

Royal Marsden - Surrey, Sutton, England, United Kingdom

Torbay Hospital, Torquay Devon, England, United Kingdom

Royal Cornwall Hospital, Truro, Cornwall, England, United Kingdom

South Tyneside District Hospital, Tyne & Wear, England, United Kingdom

Warrington Hospital NHS Trust, Warrington, England, United Kingdom

South Warwickshire Hospital, Warwick, Warwickshire, England, United Kingdom

Southend University Hospital NHS Foundation Trust, Westcliff-On-Sea, England, United Kingdom

Royal Albert Edward Infirmary, Wigan, England, United Kingdom

Royal Hampshire County Hospital, Winchester, England, United Kingdom

Clatterbridge Centre for Oncology, Wirral, England, United Kingdom

Worcester Royal Hospital, Worcester, England, United Kingdom

Yeovil District Hospital, Yeovil - Somerset, England, United Kingdom

Hairmyres Hospital, East Kilbride, Scotland, United Kingdom

Falkirk and District Royal Infirmary, Falkirk, Scotland, United Kingdom

Western Infirmary, Glasgow, Scotland, United Kingdom

Crosshouse Hospital, Kilmarnock, Scotland, United Kingdom

Wishaw General Hospital, Wishaw, Scotland, United Kingdom

Nevill Hall Hospital, Abergavenny, Wales, United Kingdom

Bronglais District General Hospital, Aberystwyth, Wales, United Kingdom

Ysbyty Gwynedd, Bangor, Wales, United Kingdom

Princess of Wales Hospital, Bridgend, Wales, United Kingdom

Velindre Cancer Center at Velindre Hospital, Cardiff, Wales, United Kingdom

West Wales General Hospital, Carmarthen, Wales, United Kingdom

Withybush General Hospital, Haverfordwest, Wales, United Kingdom

Prince Charles Hospital, Mid Glamorgan, Wales, United Kingdom

Royal Gwent Hospital, Newport Gwent, Wales, United Kingdom

Glan Clwyd Hospital, Rhyl, Denbighshire, Wales, United Kingdom

South West Wales Cancer Institute, Swansea, Wales, United Kingdom

Wrexham Maelor Hospital, Wrexham, Wales, United Kingdom

Royal Glamorgan Hospital, Llantrisant, , United Kingdom

Contact Details

Name: Peter J. Barrett Lee, MD

Affiliation: Velindre NHS Trust

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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