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.
- 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
- Compare the number of occult vertebral fractures present in patients at the end of
- Compare the pain and analgesic scores and quality of life of patients treated with
- Compare the number of patients developing renal dysfunction or hypocalcemia during the
- Compare the number of patients developing osteonecrosis of the jaw during study
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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Royal Glamorgan Hospital, Llantrisant CF72 8XR, United Kingdom
William Harvey Hospital, Ashford, England TN24 0LZ, United Kingdom
North Devon District Hospital, Barnstaple, England EX31 4JB, United Kingdom
Royal Bournemouth Hospital, Bournemouth, England BH7 7DW, United Kingdom
Burnley General Hospital, Burnley, England BB10 2PQ, United Kingdom
Queen's Hospital, Burton-upon-Trent, England DE13 0RB, United Kingdom
Kent and Canterbury Hospital, Canterbury, England CT1 3NG, United Kingdom
Broomfield Hospital, Chelmsford, Essex, England CM1 7ET, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital, Cheltenham, England GL53 7AN, United Kingdom
Countess of Chester Hospital, Chester, England CH2 1UL, United Kingdom
Essex County Hospital, Colchester, England C03 3NB, United Kingdom
Walsgrave Hospital, Coventry, England CV2 2DX, United Kingdom
Darent Valley Hospital, Dartford Kent, England DA2 8DA, United Kingdom
Derbyshire Royal Infirmary, Derby, England DE1 2QY, United Kingdom
Dorset County Hospital, Dorchester, England DT1 2JY, United Kingdom
University Hospital of North Durham, Durham, England DH1 5TW, United Kingdom
Royal Devon and Exeter Hospital, Exeter, England EX2 5DW, United Kingdom
Queen Elizabeth Hospital, Gateshead, England NE9 7UD, United Kingdom
Diana Princess of Wales Hospital, Grimsby, England DN33 2BA, United Kingdom
Calderdale Royal Hospital, Halifax, England HX3 0PW, United Kingdom
University Hospital of Hartlepool, Hartlepool, Cleveland, England TS24 9AH, United Kingdom
Wycombe General Hospital, High Wycombe, England HP11 2TT, United Kingdom
Huddersfield Royal Infirmary, Huddersfield, West Yorks, England HD3 3EA, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust, Hull, England HU8 9HE, United Kingdom
Ipswich Hospital, Ipswich, England IP4 5PD, United Kingdom
Royal Liverpool University Hospital, Liverpool, England L7 8XP, United Kingdom
Charing Cross Hospital, London, England W6 8RF, United Kingdom
Royal Marsden - London, London, England SW3 6JJ, United Kingdom
Saint Bartholomew's Hospital, London, England EC1A 7BE, United Kingdom
St. George's Hospital, London, England SW17 0QT, United Kingdom
Whipps Cross Hospital, London, England E11 1NR, United Kingdom
Macclesfield District General Hospital, Macclesfield, England SK10 3BL, United Kingdom
Maidstone Hospital, Maidstone, England ME16 9QQ, United Kingdom
Queen Elizabeth The Queen Mother Hospital, Margate, England CT9 4AN, United Kingdom
St. Mary's Hospital, Newport, England PO30 5TG, United Kingdom
King's Mills Hospital, Nottinghamshire, England NG17 4JL, United Kingdom
Nottingham City Hospital, Nottingham, England NG5 1PB, United Kingdom
George Eliot Hospital, Nuneaton, England CV10 7DJ, United Kingdom
Peterborough Hospitals Trust, Peterborough, England PE3 6DA, United Kingdom
Dorset Cancer Centre, Poole Dorset, England BH15 2JB, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital, Portsmouth, England P03 6AD, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital, Preston, England PR2 9HT, United Kingdom
Alexandra Healthcare NHS, Redditch, Worcestershire, England B98 7UB, United Kingdom
Conquest Hospital, Saint Leonards-on-Sea, England TN37 7RD, United Kingdom
Scarborough General Hospital, Scarborough, England YO12 6QL, United Kingdom
Scunthorpe General Hospital, Scunthorpe, England ON15 7BH, United Kingdom
Wexham Park Hospital, Slough, Berkshire, England SL2 4HL, United Kingdom
Solihull Hospital, Solihull, England B91 2JL, United Kingdom
Southampton General Hospital, Southampton, England SO16 6YD, United Kingdom
University Hospital of North Tees, Stockton-On-Tees, England TS19 8PE, United Kingdom
Royal Marsden - Surrey, Sutton, England SM2 5PT, United Kingdom
Torbay Hospital, Torquay Devon, England TQ2 7AA, United Kingdom
Royal Cornwall Hospital, Truro, Cornwall, England TR1 3LJ, United Kingdom
South Tyneside District Hospital, Tyne & Wear, England NE34 0PL, United Kingdom
Warrington Hospital NHS Trust, Warrington, England WA5 1QG, United Kingdom
South Warwickshire Hospital, Warwick, Warwickshire, England CV34 5BW, United Kingdom
Southend University Hospital NHS Foundation Trust, Westcliff-On-Sea, England SS0 0RY, United Kingdom
Royal Albert Edward Infirmary, Wigan, England WN1 2NN, United Kingdom
Royal Hampshire County Hospital, Winchester, England SO22 5DG, United Kingdom
Clatterbridge Centre for Oncology, Wirral, England CH63 4JY, United Kingdom
Worcester Royal Hospital, Worcester, England WR5 1AN, United Kingdom
Yeovil District Hospital, Yeovil - Somerset, England BA21 4AT, United Kingdom
Hairmyres Hospital, East Kilbride, Scotland G75 8RG, United Kingdom
Falkirk and District Royal Infirmary, Falkirk, Scotland FK1 5QE, United Kingdom
Western Infirmary, Glasgow, Scotland G11 6NT, United Kingdom
Crosshouse Hospital, Kilmarnock, Scotland KA2 OBE, United Kingdom
Wishaw General Hospital, Wishaw, Scotland ML2 0DP, United Kingdom
Nevill Hall Hospital, Abergavenny, Wales NP7 7EG, United Kingdom
Bronglais District General Hospital, Aberystwyth, Wales SY23 1ER, United Kingdom
Ysbyty Gwynedd, Bangor, Wales LL57 2PW, United Kingdom
Princess of Wales Hospital, Bridgend, Wales CF31 1JP, United Kingdom
Velindre Cancer Center at Velindre Hospital, Cardiff, Wales CF14 2TL, United Kingdom
West Wales General Hospital, Carmarthen, Wales SA31 2AF, United Kingdom
Withybush General Hospital, Haverfordwest, Wales SA61 2PZ, United Kingdom
Prince Charles Hospital, Mid Glamorgan, Wales CF47 9DT, United Kingdom
Royal Gwent Hospital, Newport Gwent, Wales NP20 2UB, United Kingdom
Glan Clwyd Hospital, Rhyl, Denbighshire, Wales LL 18 5UJ, United Kingdom
South West Wales Cancer Institute, Swansea, Wales SA2 8QA, United Kingdom
Wrexham Maelor Hospital, Wrexham, Wales LL13 7TD, United Kingdom