Breast Cancer Clinical Trial
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
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.
Status | Active, not recruiting |
Enrollment | 1404 |
Est. completion date | October 2015 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - 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) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nevill Hall Hospital | Abergavenny | Wales |
United Kingdom | Bronglais District General Hospital | Aberystwyth | Wales |
United Kingdom | William Harvey Hospital | Ashford | England |
United Kingdom | Ysbyty Gwynedd | Bangor | Wales |
United Kingdom | North Devon District Hospital | Barnstaple | England |
United Kingdom | Royal Bournemouth Hospital | Bournemouth | England |
United Kingdom | Princess of Wales Hospital | Bridgend | Wales |
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 | Velindre Cancer Center at Velindre Hospital | Cardiff | Wales |
United Kingdom | West Wales General Hospital | Carmarthen | Wales |
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 | Hairmyres Hospital | East Kilbride | Scotland |
United Kingdom | Royal Devon and Exeter Hospital | Exeter | England |
United Kingdom | Falkirk and District Royal Infirmary | Falkirk | Scotland |
United Kingdom | Queen Elizabeth Hospital | Gateshead | England |
United Kingdom | Western Infirmary | Glasgow | Scotland |
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 | Withybush General Hospital | Haverfordwest | Wales |
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 | Crosshouse Hospital | Kilmarnock | Scotland |
United Kingdom | Royal Liverpool University Hospital | Liverpool | England |
United Kingdom | Royal Glamorgan Hospital | Llantrisant | |
United Kingdom | Charing Cross Hospital | London | England |
United Kingdom | Royal Marsden - London | London | England |
United Kingdom | Saint Bartholomew's Hospital | London | England |
United Kingdom | St. George's Hospital | London | England |
United Kingdom | Whipps 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 | Prince Charles Hospital | Mid Glamorgan | Wales |
United Kingdom | St. Mary's Hospital | Newport | England |
United Kingdom | Royal Gwent Hospital | Newport Gwent | Wales |
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 | Glan Clwyd Hospital | Rhyl, Denbighshire | Wales |
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 | South West Wales Cancer Institute | Swansea | Wales |
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 | Wishaw General Hospital | Wishaw | Scotland |
United Kingdom | Worcester Royal Hospital | Worcester | England |
United Kingdom | Wrexham Maelor Hospital | Wrexham | Wales |
United Kingdom | Yeovil District Hospital | Yeovil - Somerset | England |
Lead Sponsor | Collaborator |
---|---|
Wales Cancer Trials Unit | Velindre NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and timing of skeletal-related events (SREs) | 96 weeks | No | |
Secondary | Time to first SREs | 96 Weeks | No | |
Secondary | Proportion of patients with SREs | 96 Weeks | No | |
Secondary | Pain and analgesic score | 96 weeks | No | |
Secondary | Quality of life | 96 weeks | No | |
Secondary | Toxicity | 96 weeks | Yes | |
Secondary | Survival | 5 years | No | |
Secondary | Health resource usage and serum bone marker levels | 96 weeks | No |
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