Breast CancerPhase 3NCT00326820

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

A Phase 3 study testing ibandronate sodium, zoledronic acid and Zolendronic Acid in people with Breast Cancer and Hypercalcemia of Malignancy, run by Wales Cancer Trials Unit at 79 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer
What is being tested?: ibandronate sodium, zoledronic acid and Zolendronic Acid
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,404 participants
Where: 79 sitesUnited Kingdom
Study dates: Jan 2006to Oct 2015
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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 locations and contacts

79 sites in 1 country.

City, postcode or hospital

79 sites in 1 country

United Kingdom79 sites

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

Other trials in United Kingdom

About this study

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

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.

Read the 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 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.

Conditions: Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer
Being tested: ibandronate sodium, zoledronic acid, Zolendronic Acid
Keywords: hypercalcemia of malignancy, stage IV breast cancer, bone metastases, recurrent breast cancer, male breast cancer
Medical subject headings: Breast Neoplasms, Humoral Hypercalcemia Of Malignancy, Neoplasm Metastasis, Breast Neoplasms, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ibandronate sodiumDrug
zoledronic acidDrug
Zolendronic AcidDrug
Also called Zoledronate
Zoledronic acid 4 mg by intravenous infusion every 4 weeks.

Study groups in NCT00326820
Study group	Role	What they receive
Ibandronic Acid	Experimental	50mg tablet once daily over 96 weeks Receives: Drug: ibandronate sodium
Zoledronic Acid	Active comparator	4 mg via intravenous infusion (iv) over a minimum of 15 minutes in at least 100mls of saline every 4 weeks over 96 weeks Receives: Drug: zoledronic acid; Drug: Zolendronic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency and timing of skeletal-related events (SREs)
Measured: 96 weeks

Secondary outcomes (7)

Time to first SREs
Measured: 96 Weeks
Proportion of patients with SREs
Measured: 96 Weeks
Pain and analgesic score
Measured: 96 weeks
Quality of life
Measured: 96 weeks
Toxicity
Measured: 96 weeks
Survival
Measured: 5 years
Health resource usage and serum bone marker levels
Measured: 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Oct 2015

First posted17 May 2006 (estimated)
Study startJan 2006
Primary completionDec 2012
Study completionOct 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,404 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00326820
Sponsor's protocol ID: CDR0000478864
Other IDs: WCTU-ZICE, NCRI-ZICE, ROCHE-ZICE, ISRCTN13914201, EU-20613, EUDRACT-2005-001710-40
Status last verified: Mar 2013
First submitted: 16 May 2006
Last updated: 13 Mar 2013
Results posted: No
Data monitoring committee: Yes

Publications

Gillespie D, Farewell D, Barrett-Lee P, Casbard A, Hawthorne AB, Hurt C, Murray N, Probert C, Stenson R, Hood K. The use of randomisation-based efficacy estimators in non-inferiority trials. Trials. 2017 Mar 9;18(1):117. doi: 10.1186/s13063-017-1837-3.
PubMed 28274254
Barrett-Lee P, Casbard A, Abraham J, Hood K, Coleman R, Simmonds P, Timmins H, Wheatley D, Grieve R, Griffiths G, Murray N. Oral ibandronic acid versus intravenous zoledronic acid in treatment of bone metastases from breast cancer: a randomised, open label, non-inferiority phase 3 trial. Lancet Oncol. 2014 Jan;15(1):114-22. doi: 10.1016/S1470-2045(13)70539-4. Epub 2013 Dec 11.
PubMed 24332514

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00326820
Acronym / sponsor ID: CDR0000478864
Conditions: Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer
Keywords: hypercalcemia of malignancy, stage IV breast cancer, bone metastases, recurrent breast cancer, male breast cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,404 participants (actual)
Lead sponsor: Wales Cancer Trials UnitUniversity, hospital or other
Collaborators: Velindre NHS Trust
Study start: Jan 2006
Primary completion: Dec 2012 (actual)
Study completion: Oct 2015 (estimated)
First posted: 17 May 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ibandronic Acid	Experimental	Drug: ibandronate sodium50mg tablet once daily over 96 weeks
Zoledronic Acid	Active comparator	Drug: zoledronic acid, Drug: Zolendronic Acid4 mg via intravenous infusion (iv) over a minimum of 15 minutes in at least 100mls of saline every 4 weeks over 96 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ibandronate sodium	Drug	Ibandronic Acid
zoledronic acid	Drug	Zoledronic Acid
Zolendronic AcidAlso: ZoledronateZoledronic acid 4 mg by intravenous infusion every 4 weeks.	Drug	Zoledronic Acid

Primary outcome

Frequency and timing of skeletal-related events (SREs)
Time frame: 96 weeks

7 secondary outcomes

Time to first SREs
Time frame: 96 Weeks
Proportion of patients with SREs
Time frame: 96 Weeks
Pain and analgesic score
Time frame: 96 weeks
Quality of life
Time frame: 96 weeks
Toxicity
Time frame: 96 weeks
Survival
Time frame: 5 years
Health resource usage and serum bone marker levels
Time frame: 96 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
Derived from this study: PubMed 28274254Gillespie D, Farewell D, Barrett-Lee P, Casbard A, Hawthorne AB, Hurt C, Murray N, Probert C, Stenson R, Hood K. The use of randomisation-based efficacy estimators in non-inferiority trials. Trials. 2017 Mar 9;18(1):117. doi: 10.1186/s13063-017-1837-3.
Derived from this study: PubMed 24332514Barrett-Lee P, Casbard A, Abraham J, Hood K, Coleman R, Simmonds P, Timmins H, Wheatley D, Grieve R, Griffiths G, Murray N. Oral ibandronic acid versus intravenous zoledronic acid in treatment of bone metastases from breast cancer: a randomised, open label, non-inferiority phase 3 trial. Lancet Oncol. 2014 Jan;15(1):114-22. doi: 10.1016/S1470-2045(13)70539-4. Epub 2013 Dec 11.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter J. Barrett Lee, MD study chair

Velindre NHS Trust

79 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and timing of skeletal-related events (SREs) (time frame: 96 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00326820, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2013.