Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer
- Conditions
- Breast CancerHypercalcemia of MalignancyMetastatic Cancer
- Interventions
- Registration Number
- NCT00326820
- Lead Sponsor
- Wales Cancer Trials Unit
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1404
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ibandronic Acid ibandronate sodium 50mg tablet once daily over 96 weeks Zoledronic Acid Zolendronic Acid 4 mg via intravenous infusion (iv) over a minimum of 15 minutes in at least 100mls of saline every 4 weeks over 96 weeks Zoledronic Acid zoledronic acid 4 mg via intravenous infusion (iv) over a minimum of 15 minutes in at least 100mls of saline every 4 weeks over 96 weeks
- Primary Outcome Measures
Name Time Method Frequency and timing of skeletal-related events (SREs) 96 weeks
- Secondary Outcome Measures
Name Time Method Toxicity 96 weeks Survival 5 years Time to first SREs 96 Weeks Proportion of patients with SREs 96 Weeks Pain and analgesic score 96 weeks Quality of life 96 weeks Health resource usage and serum bone marker levels 96 weeks
Trial Locations
- Locations (79)
St. Mary's Hospital
🇬🇧Newport, England, United Kingdom
Dorset Cancer Centre
🇬🇧Poole Dorset, England, United Kingdom
Alexandra Healthcare NHS
🇬🇧Redditch, Worcestershire, England, United Kingdom
Scarborough General Hospital
🇬🇧Scarborough, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Royal Marsden - London
🇬🇧London, England, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
Macclesfield District General Hospital
🇬🇧Macclesfield, England, United Kingdom
Peterborough Hospitals Trust
🇬🇧Peterborough, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
🇬🇧Preston, England, United Kingdom
Torbay Hospital
🇬🇧Torquay Devon, England, United Kingdom
Hairmyres Hospital
🇬🇧East Kilbride, Scotland, United Kingdom
Whipps Cross Hospital
🇬🇧London, England, United Kingdom
Calderdale Royal Hospital
🇬🇧Halifax, England, United Kingdom
Huddersfield Royal Infirmary
🇬🇧Huddersfield, West Yorks, England, United Kingdom
Wycombe General Hospital
🇬🇧High Wycombe, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
King's Mills Hospital
🇬🇧Nottinghamshire, England, United Kingdom
George Eliot Hospital
🇬🇧Nuneaton, England, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, England, United Kingdom
Conquest Hospital
🇬🇧Saint Leonards-on-Sea, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
🇬🇧Portsmouth, England, United Kingdom
Scunthorpe General Hospital
🇬🇧Scunthorpe, England, United Kingdom
Wexham Park Hospital
🇬🇧Slough, Berkshire, England, United Kingdom
Royal Hampshire County Hospital
🇬🇧Winchester, England, United Kingdom
Princess of Wales Hospital
🇬🇧Bridgend, Wales, United Kingdom
Wrexham Maelor Hospital
🇬🇧Wrexham, Wales, United Kingdom
Diana Princess of Wales Hospital
🇬🇧Grimsby, England, United Kingdom
University Hospital of Hartlepool
🇬🇧Hartlepool, Cleveland, England, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
🇬🇧Hull, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
South Warwickshire Hospital
🇬🇧Warwick, Warwickshire, England, United Kingdom
Royal Albert Edward Infirmary
🇬🇧Wigan, England, United Kingdom
Prince Charles Hospital
🇬🇧Mid Glamorgan, Wales, United Kingdom
Glan Clwyd Hospital
🇬🇧Rhyl, Denbighshire, Wales, United Kingdom
Royal Glamorgan Hospital
🇬🇧Llantrisant, United Kingdom
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
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
University Hospital of North Durham
🇬🇧Durham, England, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Darent Valley Hospital
🇬🇧Dartford Kent, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧Gateshead, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital
🇬🇧Margate, England, United Kingdom
Solihull Hospital
🇬🇧Solihull, England, United Kingdom
University Hospital of North Tees
🇬🇧Stockton-On-Tees, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
South Tyneside District Hospital
🇬🇧Tyne & Wear, England, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, 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
Western Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Falkirk and District Royal Infirmary
🇬🇧Falkirk, Scotland, United Kingdom
Crosshouse Hospital
🇬🇧Kilmarnock, Scotland, United Kingdom
Bronglais District General Hospital
🇬🇧Aberystwyth, Wales, United Kingdom
Wishaw General Hospital
🇬🇧Wishaw, Scotland, United Kingdom
Nevill Hall Hospital
🇬🇧Abergavenny, Wales, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, 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
Royal Gwent Hospital
🇬🇧Newport Gwent, Wales, United Kingdom
South West Wales Cancer Institute
🇬🇧Swansea, Wales, United Kingdom
St. George's Hospital
🇬🇧London, England, United Kingdom
Warrington Hospital NHS Trust
🇬🇧Warrington, England, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, England, United Kingdom