Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer
NCT ID: NCT00326820
Last Updated: 2013-03-13
Study Results
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Basic Information
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UNKNOWN
PHASE3
1404 participants
INTERVENTIONAL
2006-01-31
2015-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ibandronic Acid
50mg tablet once daily over 96 weeks
ibandronate sodium
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
zoledronic acid
Zolendronic Acid
Zoledronic acid 4 mg by intravenous infusion every 4 weeks.
Interventions
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ibandronate sodium
zoledronic acid
Zolendronic Acid
Zoledronic acid 4 mg by intravenous infusion every 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proven breast cancer
* Metastatic disease
* Previous relapsed disease in sites other than bone allowed
* Newly diagnosed multiple bone metastases within the past 3 months, meeting all of the following criteria:
* Painful or asymptomatic
* Lytic, mixed, or purely sclerotic type
* Radiological diagnosis
* IV bisphosphonate therapy indicated
* No CNS metastases
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Male or female
* Menopausal status not specified
* No known active peptic ulcer
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active dental problems, including infection of the teeth or jawbone (maxilla or mandible) or dental or fixture trauma
* No prior or current diagnosis of osteonecrosis of the jaw, exposed bone in the mouth, or slow healing after dental procedures
* Creatinine clearance ≥ 30 mL/min
* Bilirubin ≤ 1.5 x upper limit of normal (ULN)
* AST and ALT ≤ 1.5 times ULN
* No history of bisphosphonate hypersensitivity
* Able to comply with instructions relating to oral study medications
* Able to take oral study medications
* No psychiatric illness or other condition that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
* At least 6 months since prior bisphosphonate therapy
* At least 6 weeks since prior and no concurrent dental or jaw surgery (e.g., extractions or implants)
* Concurrent unplanned dental extractions allowed provided study medication is discontinued for 8 weeks before and after the surgery
* Concurrent chemotherapy and/or hormone therapy for metastatic disease allowed
* No concurrent medications that affect bone metabolism (e.g., calcitonin or other nontrial bisphosphonates)
18 Years
ALL
No
Sponsors
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Velindre NHS Trust
OTHER_GOV
Wales Cancer Trials Unit
OTHER
Responsible Party
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Principal Investigators
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Peter J. Barrett Lee, MD
Role: STUDY_CHAIR
Velindre NHS Trust
Locations
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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-on-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
Clatterbridge Centre for Oncology
Metropolitan Borough of Wirral, England, United Kingdom
St. Mary's Hospital
Newport, England, United Kingdom
Nottingham City Hospital
Nottingham, England, United Kingdom
King's Mills Hospital
Nottinghamshire, 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
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
Countries
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References
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Gillespie D, Farewell D, Barrett-Lee P, Casbard A, Hawthorne AB, Hurt C, Murray N, Probert C, Stenson R, Hood K. The use of randomisation-based efficacy estimators in non-inferiority trials. Trials. 2017 Mar 9;18(1):117. doi: 10.1186/s13063-017-1837-3.
Barrett-Lee P, Casbard A, Abraham J, Hood K, Coleman R, Simmonds P, Timmins H, Wheatley D, Grieve R, Griffiths G, Murray N. Oral ibandronic acid versus intravenous zoledronic acid in treatment of bone metastases from breast cancer: a randomised, open label, non-inferiority phase 3 trial. Lancet Oncol. 2014 Jan;15(1):114-22. doi: 10.1016/S1470-2045(13)70539-4. Epub 2013 Dec 11.
Other Identifiers
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WCTU-ZICE
Identifier Type: -
Identifier Source: secondary_id
NCRI-ZICE
Identifier Type: -
Identifier Source: secondary_id
ROCHE-ZICE
Identifier Type: -
Identifier Source: secondary_id
ISRCTN13914201
Identifier Type: -
Identifier Source: secondary_id
EU-20613
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2005-001710-40
Identifier Type: -
Identifier Source: secondary_id
CDR0000478864
Identifier Type: -
Identifier Source: org_study_id
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