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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00326820
Other study ID # CDR0000478864
Secondary ID WCTU-ZICENCRI-ZI
Status Active, not recruiting
Phase Phase 3
First received May 16, 2006
Last updated March 12, 2013
Start date January 2006
Est. completion date October 2015

Study information

Verified date March 2013
Source Wales Cancer Trials Unit
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


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 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.


Recruitment information / eligibility

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)

Study Design

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


Intervention

Drug:
ibandronate sodium

zoledronic acid

Zolendronic Acid
Zoledronic acid 4 mg by intravenous infusion every 4 weeks.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Wales Cancer Trials Unit Velindre NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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