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

Information source: Wales Cancer Trials Unit
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Hypercalcemia of Malignancy; Metastatic Cancer

Intervention: ibandronate sodium (Drug); zoledronic acid (Drug); Zolendronic Acid (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Wales Cancer Trials Unit

Official(s) and/or principal investigator(s):
Peter J. Barrett Lee, MD, Study Chair, Affiliation: Velindre NHS Trust


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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Frequency and timing of skeletal-related events (SREs)

Secondary outcome:

Time to first SREs

Proportion of patients with SREs

Pain and analgesic score

Quality of life



Health resource usage and serum bone marker levels

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


- 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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


- 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


- 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)

Locations and Contacts

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

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2006
Last updated: March 12, 2013

Page last updated: August 23, 2015

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