National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
In English | En español
NCI Home Cancer Topics Clinical Trials Cancer Statistics Research & Funding News About NCI
Clinical Trials (PDQ®)
Patient VersionHealth Professional Version
Last Modified: 11/12/2007     First Published: 5/11/2006  
Page Options
Print This Page  Print This Page
E-Mail This Document  E-Mail This Document
Clinical Trial Questions?
Get Help:

1-800-4-CANCER
Quick Links
Help Using the NCI Clinical Trials Search Form

Educational Materials About Clinical Trials

About NCI's Cancer Clinical Trials Registry

Dictionary of Cancer Terms

NCI Drug Dictionary
Phase III Randomized Study of Ibandronate Versus Zoledronate in Patients With Newly Diagnosed Bone Metastases Secondary to Breast Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActiveOver 18Other, Pharmaceutical / IndustryWCTU-ZICE
NCRI-ZICE, ROCHE-ZICE, ISRCTN13914201, EU-20613, EUDRACT-2005-001710-40, NCT00326820

Objectives

Primary

  1. 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

  1. Compare the median time to first SRE in patients treated with these regimens.
  2. Compare the percentage of patients experiencing a SRE after treatment with these regimens.
  3. Compare the number of occult vertebral fractures present in patients at the end of treatment with these regimens.
  4. Compare the pain and analgesic scores and quality of life of patients treated with these regimens.
  5. Compare the number of patients developing renal dysfunction or hypocalcemia during the study period.
  6. Compare the number of patients developing osteonecrosis of the jaw during study treatment and follow-up.
  7. Compare the overall survival of these patients at 96 weeks and at 5 years.
  8. Compare the health-resource usage of patients treated with these regimens.

Entry Criteria

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

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)

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

Expected Enrollment

1400

A total of 1,400 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Frequency and timing of skeletal-related events (SREs)

Secondary Outcome(s)

Time to first SREs
Proportion of patients with SREs
Pain and analgesic score
Quality of life
Toxicity
Survival
Health resource usage and serum bone marker levels

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.

Trial Contact Information

Trial Lead Organizations

Wales Cancer Trials Unit

Peter J. Barrett Lee, MD, Protocol chair
Ph: 44-29-2031-6292

Trial Sites

United Kingdom
  Llantrisant
 Royal Glamorgan Hospital
 Contact Person
Ph: 44-144-344-3443
England
  Ashford
 William Harvey Hospital
 Contact Person
Ph: 44-123-363-3331
  Barnstaple
 North Devon District Hospital
 Contact Person
Ph: 44-12-7132-2577
  Bournemouth
 Royal Bournemouth Hospital NHS Trust
 Contact Person
Ph: 44-120-230-3626
  Burnley
 Burnley General Hospital
 Contact Person
Ph: 44-128-242-5071
  Burton-upon-Trent
 Queen's Hospital
 Contact Person
Ph: 44-128-356-6333
  Canterbury
 Kent and Canterbury Hospital
 Contact Person
Ph: 44-122-776-6877
  Chelmsford, Essex
 Broomfield Hospital
 Contact Person
Ph: 44-12-4544-0761
  Cheltenham
 Gloucestershire Oncology Centre at Cheltenham General Hospital
 Contact Person
Ph: 44-845-422-2222
  Chester
 Countess of Chester Hospital
 Contact Person
Ph: 44-124-436-5000
  Colchester
 Essex County Hospital
 Contact Person
Ph: 44-120-674-7474
  Coventry
 Walsgrave Hospital
 Contact Person
Ph: 44-247-660-2020
  Dartford Kent
 Darent Valley Hospital
 Contact Person
Ph: 44-132-242-8100
  Derby
 Derbyshire Royal Infirmary
 Contact Person
Ph: 44-133-234-7141
  Dorchester
 Dorset County Hospital
 Contact Person
Ph: 44-130-525-1150
  Durham
 University Hospital of North Durham
 Contact Person
Ph: 44-191-333-2333
  Exeter
 Royal Devon and Exeter Hospital
 Contact Person
Ph: 44-139-240-118
  Gateshead
 Queen Elizabeth Hospital
 Contact Person
Ph: 44-191-482-0000
  Grimsby
 Diana Princess of Wales Hospital
 Contact Person
Ph: 44-147-287-4111
  Halifax
 Calderdale Royal Hospital
 Contact Person
Ph: 44-142-235-7171
  Hartlepool, Cleveland
 University Hospital of Hartlepool
 Contact Person
Ph: 44-142-926-6654
  High Wycombe
 Wycombe General Hospital
 Contact Person
Ph: 44-149-452-6161
  Huddersfield, West Yorks
 Huddersfield Royal Infirmary
 Contact Person
Ph: 44-148-434-2000
  Hull
 Princess Royal Hospital at Hull and East Yorkshire NHS Trust
 Contact Person
Ph: 44-148-270-1151
  Ipswich
 Ipswich Hospital
 Contact Person
Ph: 44-147-371-2233
  Liverpool
 Royal Liverpool University Hospital
 Contact Person
Ph: 44-151-334-1155
  London
 Charing Cross Hospital
 Contact Person
Ph: 44-20-8846-1234
 Royal Marsden - London
 Contact Person
Ph: 44-20-7352-8171
 Saint Bartholomew's Hospital
 Contact Person
Ph: 44-20-7377-7000
 St. George's Hospital
 Contact Person
Ph: 44-20-8672-1255
 Whipps Cross Hospital
 Contact Person
Ph: 44-20-8539-5522
  Macclesfield
 Macclesfield District General Hospital
 Contact Paerson
Ph: 44-162-542-1000
  Maidstone
 Maidstone Hospital
 Contact Person
Ph: 44-16-2272-9000
  Margate
 Queen Elizabeth The Queen Mother Hospital
 Contact Person
Ph: 44-184-322-5544
  Newport
 St. Mary's Hospital
 Contact Person
Ph: 44-198-352-4081
  Nottingham
 Nottingham City Hospital NHS Trust
 Contact Person
Ph: 44-115-969-1169
  Nottinghamshire
 King's Mills Hospital
 Contact Person
Ph: 44-162-362-2515
  Nuneaton
 George Eliot Hospital
 Contact Person
Ph: 44-247-635-1351
  Peterborough
 Peterborough Hospitals Trust
 Contact Person
Ph: 44-17-1187-4000
  Poole Dorset
 Dorset Cancer Centre
 Contact Person
Ph: 44-120-266-5511
  Portsmouth
 Portsmouth Oncology Centre at Saint Mary's Hospital
 Contact Person
Ph: 44-23-9228-6000
  Preston
 Rosemere Cancer Centre at Royal Preston Hospital
 Contact Person
Ph: 44-177-271-6565
  Redditch, Worcestershire
 Alexandra Healthcare NHS
 Contact Person
Ph: 44-152-750-3030
  Saint Leonards-on-Sea
 Conquest Hospital
 Contact Person
Ph: 44-14-2475-5255
  Scarborough
 Scarborough General Hospital
 Contact Person
Ph: 44-172-336-8111
  Scunthorpe
 Scunthorpe General Hospital
 Contact Person
Ph: 44-172-428-2282
  Slough, Berkshire
 Wexham Park Hospital
 Contact Person
Ph: 44-175-363-3000
  Solihull
 Solihull Hospital
 Contact Person
Ph: 44-121-424-2000
  Southampton
 Southampton General Hospital
 Contact Person
Ph: 44-23-8077-7222
  Stockton-On-Tees
 University Hospital of North Tees
 Contact Person
Ph: 44-164-261-7617
  Sutton
 Royal Marsden - Surrey
 Contact Person
Ph: 44-20-8642-6011
  Torquay Devon
 Torbay Hospital
 Contact Person
Ph: 44-180-361-4567
  Truro, Cornwall
 Royal Cornwall Hospital
 Contact Person
Ph: 44-187-225-0000
  Tyne & Wear
 South Tyneside District Hospital
 Contact Person
Ph: 44-844-811-3030
  Warrington
 Warrington Hospital NHS Trust
 Contact Person
Ph: 44-192-563-5911
  Warwick, Warwickshire
 South Warwickshire Hospital
 Contact Person
Ph: 44-192-649-5321
  Westcliff-On-Sea
 Southend University Hospital NHS Foundation Trust
 Contact Person
Ph: 44-170-243-5555
  Wigan
 Royal Albert Edward Infirmary
 Contact Person
Ph: 44-194-224-4000
  Winchester
 Royal Hampshire County Hospital
 Contact Person
Ph: 44-196-286-3535
  Wirral
 Clatterbridge Centre for Oncology
 Contact Person
Ph: 44-151-334-1155
  Worcester
 Worcester Royal Hospital
 Contact Person
Ph: 44-190-576-3333
  Yeovil - Somerset
 Yeovil District Hospital
 Contact Person
Ph: 44-193-547-5122
Scotland
  East Kilbride
 Hairmyres Hospital
 Contact Person
Ph: 44-135-558-5000
  Falkirk
 Falkirk and District Royal Infirmary
 Contact Person
Ph: 44-132-462-4000
  Glasgow
 Western Infirmary
 Contact Person
Ph: 44-141-211-2829
  Kilmarnock
 Crosshouse Hospital
 Contact Person
Ph: 44-156-352-1133
  Wishaw
 Wishaw General Hospital
 Contact Person
Ph: 44-169-836-1100
Wales
  Abergavenny
 Nevill Hall Hospital
 Contact Person
Ph: 44-187-373-2732
  Aberystwyth
 Bronglais District General Hospital
 Contact Person
Ph: 44-19-7062-3131
  Bangor
 Ysbyty Gwynedd
 Contact Person
Ph: 44-124-838-4384
  Bridgend
 Princess of Wales Hospital
 Contact Person
Ph: 44-165-675-2752
  Cardiff
 Velindre Cancer Center at Velindre Hospital
 Peter J. Barrett Lee, MD
Ph: 44-29-2031-6292
  Carmarthen
 West Wales General Hospital
 Contact Person
Ph: 44-126-723-5151
  Haverfordwest
 Withybush General Hospital
 Contact Person
Ph: 44-143-774-4545
  Mid Glamorgan
 Prince Charles Hospital
 Contact Person
Ph: 44-168-572-1721
  Newport Gwent
 Royal Gwent Hospital
 Contact Person
Ph: 44-163-362-3623
  Rhyl, Denbighshire
 Glan Clwyd Hospital
 Contact Person
Ph: 44-174-558-3910
  Swansea
 South West Wales Cancer Institute
 Contact Person
Ph: 44-179-220-5666
  Wrexham
 Wrexham Maelor Hospital
 Contact Person
Ph: 44-197-829-1100

Registry Information
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 [ZICE]
Trial Start Date 2006-01-04
Trial Completion Date 2011-01-04 (estimated)
Registered in ClinicalTrials.gov NCT00326820
Date Submitted to PDQ 2006-03-30
Information Last Verified 2007-10-14

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Back to TopBack to Top

A Service of the National Cancer Institute
Department of Health and Human Services National Institutes of Health USA.gov