Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer
Trial Sites
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Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Biomarker/Laboratory analysis, Supportive care, Treatment | Active | Over 18 | Other | CDR0000478864 WCTU-ZICE, NCRI-ZICE, ROCHE-ZICE, ISRCTN13914201, EU-20613, EUDRACT-2005-001710-40, NCT00326820 |
Summary
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.
Further Study Information
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 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.
Eligibility 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
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)
Trial Lead Organizations/Sponsors
Wales Cancer Trials Unit
| Peter J. Barrett Lee |  | Study Chair |
Trial Sites
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| United Kingdom | |||
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| Llantrisant | |||
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| Royal Glamorgan Hospital | |||
| Contact Person | Ph: 44-144-344-3443 | ||
| England | |||
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| Ashford | |||
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| William Harvey Hospital | |||
| Contact Person | Ph: 44-123-363-3331 | ||
| Barnstaple | |||
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| North Devon District Hospital | |||
| Contact Person | Ph: 44-12-7132-2577 | ||
| Bournemouth | |||
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| Royal Bournemouth Hospital | |||
| Contact Person | Ph: 44-120-230-3626 | ||
| Burnley | |||
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| Burnley General Hospital | |||
| Contact Person | Ph: 44-128-242-5071 | ||
| Burton-upon-Trent | |||
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| Queen's Hospital | |||
| Contact Person | Ph: 44-128-356-6333 | ||
| Canterbury | |||
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| Kent and Canterbury Hospital | |||
| Contact Person | Ph: 44-122-776-6877 | ||
| Chelmsford, Essex | |||
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| Broomfield Hospital | |||
| Contact Person | Ph: 44-12-4544-0761 | ||
| Cheltenham | |||
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| Gloucestershire Oncology Centre at Cheltenham General Hospital | |||
| Contact Person | Ph: 44-845-422-2222 | ||
| Chester | |||
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| Countess of Chester Hospital | |||
| Contact Person | Ph: 44-124-436-5000 | ||
| Colchester | |||
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| Essex County Hospital | |||
| Contact Person | Ph: 44-120-674-7474 | ||
| Coventry | |||
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| Walsgrave Hospital | |||
| Contact Person | Ph: 44-247-660-2020 | ||
| Dartford Kent | |||
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| Darent Valley Hospital | |||
| Contact Person | Ph: 44-132-242-8100 | ||
| Derby | |||
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| Derbyshire Royal Infirmary | |||
| Contact Person | Ph: 44-133-234-7141 | ||
| Dorchester | |||
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| Dorset County Hospital | |||
| Contact Person | Ph: 44-130-525-1150 | ||
| Durham | |||
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| University Hospital of North Durham | |||
| Contact Person | Ph: 44-191-333-2333 | ||
| Exeter | |||
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| Royal Devon and Exeter Hospital | |||
| Contact Person | Ph: 44-139-240-118 | ||
| Gateshead | |||
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| Queen Elizabeth Hospital | |||
| Contact Person | Ph: 44-191-482-0000 | ||
| Grimsby | |||
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| Diana Princess of Wales Hospital | |||
| Contact Person | Ph: 44-147-287-4111 | ||
| Halifax | |||
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| Calderdale Royal Hospital | |||
| Contact Person | Ph: 44-142-235-7171 | ||
| Hartlepool, Cleveland | |||
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| University Hospital of Hartlepool | |||
| Contact Person | Ph: 44-142-926-6654 | ||
| High Wycombe | |||
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| Wycombe General Hospital | |||
| Contact Person | Ph: 44-149-452-6161 | ||
| Huddersfield, West Yorks | |||
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| Huddersfield Royal Infirmary | |||
| Contact Person | Ph: 44-148-434-2000 | ||
| Hull | |||
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| Princess Royal Hospital at Hull and East Yorkshire NHS Trust | |||
| Contact Person | Ph: 44-148-270-1151 | ||
| Ipswich | |||
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| Ipswich Hospital | |||
| Contact Person | Ph: 44-147-371-2233 | ||
| Liverpool | |||
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| Royal Liverpool University Hospital | |||
| Contact Person | Ph: 44-151-334-1155 | ||
| London | |||
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| 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 | |||
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| Macclesfield District General Hospital | |||
| Contact Paerson | Ph: 44-162-542-1000 | ||
| Maidstone | |||
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| Maidstone Hospital | |||
| Contact Person | Ph: 44-16-2272-9000 | ||
| Margate | |||
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| Queen Elizabeth The Queen Mother Hospital | |||
| Contact Person | Ph: 44-184-322-5544 | ||
| Newport | |||
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| St. Mary's Hospital | |||
| Contact Person | Ph: 44-198-352-4081 | ||
| Nottingham | |||
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| Nottingham City Hospital | |||
| Contact Person | Ph: 44-115-969-1169 | ||
| Nottinghamshire | |||
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| King's Mills Hospital | |||
| Contact Person | Ph: 44-162-362-2515 | ||
| Nuneaton | |||
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| George Eliot Hospital | |||
| Contact Person | Ph: 44-247-635-1351 | ||
| Peterborough | |||
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| Peterborough Hospitals Trust | |||
| Contact Person | Ph: 44-17-1187-4000 | ||
| Poole Dorset | |||
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| Dorset Cancer Centre | |||
| Contact Person | Ph: 44-120-266-5511 | ||
| Portsmouth | |||
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| Portsmouth Oncology Centre at Saint Mary's Hospital | |||
| Contact Person | Ph: 44-23-9228-6000 | ||
| Preston | |||
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| Rosemere Cancer Centre at Royal Preston Hospital | |||
| Contact Person | Ph: 44-177-271-6565 | ||
| Redditch, Worcestershire | |||
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| Alexandra Healthcare NHS | |||
| Contact Person | Ph: 44-152-750-3030 | ||
| Saint Leonards-on-Sea | |||
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| Conquest Hospital | |||
| Contact Person | Ph: 44-14-2475-5255 | ||
| Scarborough | |||
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| Scarborough General Hospital | |||
| Contact Person | Ph: 44-172-336-8111 | ||
| Scunthorpe | |||
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| Scunthorpe General Hospital | |||
| Contact Person | Ph: 44-172-428-2282 | ||
| Slough, Berkshire | |||
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| Wexham Park Hospital | |||
| Contact Person | Ph: 44-175-363-3000 | ||
| Solihull | |||
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| Solihull Hospital | |||
| Contact Person | Ph: 44-121-424-2000 | ||
| Southampton | |||
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| Southampton General Hospital | |||
| Contact Person | Ph: 44-23-8077-7222 | ||
| Stockton-On-Tees | |||
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| University Hospital of North Tees | |||
| Contact Person | Ph: 44-164-261-7617 | ||
| Sutton | |||
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| Royal Marsden - Surrey | |||
| Contact Person | Ph: 44-20-8642-6011 | ||
| Torquay Devon | |||
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| Torbay Hospital | |||
| Contact Person | Ph: 44-180-361-4567 | ||
| Truro, Cornwall | |||
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| Royal Cornwall Hospital | |||
| Contact Person | Ph: 44-187-225-0000 | ||
| Tyne & Wear | |||
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| South Tyneside District Hospital | |||
| Contact Person | Ph: 44-844-811-3030 | ||
| Warrington | |||
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| Warrington Hospital NHS Trust | |||
| Contact Person | Ph: 44-192-563-5911 | ||
| Warwick, Warwickshire | |||
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| South Warwickshire Hospital | |||
| Contact Person | Ph: 44-192-649-5321 | ||
| Westcliff-On-Sea | |||
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| Southend University Hospital NHS Foundation Trust | |||
| Contact Person | Ph: 44-170-243-5555 | ||
| Wigan | |||
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| Royal Albert Edward Infirmary | |||
| Contact Person | Ph: 44-194-224-4000 | ||
| Winchester | |||
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| Royal Hampshire County Hospital | |||
| Contact Person | Ph: 44-196-286-3535 | ||
| Wirral | |||
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| Clatterbridge Centre for Oncology | |||
| Contact Person | Ph: 44-151-334-1155 | ||
| Worcester | |||
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| Worcester Royal Hospital | |||
| Contact Person | Ph: 44-190-576-3333 | ||
| Yeovil - Somerset | |||
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| Yeovil District Hospital | |||
| Contact Person | Ph: 44-193-547-5122 | ||
| Scotland | |||
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| East Kilbride | |||
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| Hairmyres Hospital | |||
| Contact Person | Ph: 44-135-558-5000 | ||
| Falkirk | |||
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| Falkirk and District Royal Infirmary | |||
| Contact Person | Ph: 44-132-462-4000 | ||
| Glasgow | |||
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| Western Infirmary | |||
| Contact Person | Ph: 44-141-211-2829 | ||
| Kilmarnock | |||
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| Crosshouse Hospital | |||
| Contact Person | Ph: 44-156-352-1133 | ||
| Wishaw | |||
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| Wishaw General Hospital | |||
| Contact Person | Ph: 44-169-836-1100 | ||
| Wales | |||
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| Abergavenny | |||
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| Nevill Hall Hospital | |||
| Contact Person | Ph: 44-187-373-2732 | ||
| Aberystwyth | |||
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| Bronglais District General Hospital | |||
| Contact Person | Ph: 44-19-7062-3131 | ||
| Bangor | |||
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| Ysbyty Gwynedd | |||
| Contact Person | Ph: 44-124-838-4384 | ||
| Bridgend | |||
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| Princess of Wales Hospital | |||
| Contact Person | Ph: 44-165-675-2752 | ||
| Cardiff | |||
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| Velindre Cancer Center at Velindre Hospital | |||
| Peter J. Barrett Lee | Ph: 44-29-2031-6292 | ||
| Carmarthen | |||
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| West Wales General Hospital | |||
| Contact Person | Ph: 44-126-723-5151 | ||
| Haverfordwest | |||
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| Withybush General Hospital | |||
| Contact Person | Ph: 44-143-774-4545 | ||
| Mid Glamorgan | |||
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| Prince Charles Hospital | |||
| Contact Person | Ph: 44-168-572-1721 | ||
| Newport Gwent | |||
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| Royal Gwent Hospital | |||
| Contact Person | Ph: 44-163-362-3623 | ||
| Rhyl, Denbighshire | |||
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| Glan Clwyd Hospital | |||
| Contact Person | Ph: 44-174-558-3910 | ||
| Swansea | |||
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| South West Wales Cancer Institute | |||
| Contact Person | Ph: 44-179-220-5666 | ||
| Wrexham | |||
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| Wrexham Maelor Hospital | |||
| Contact Person | Ph: 44-197-829-1100 | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00326820
Information obtained from ClinicalTrials.gov on January 19, 2012
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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