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

NCT00326820 | Unknown Phase 3 DMC

• 7 other identifiers: CDR0000478864WCTU-ZICENCRI-ZICEROCHE-ZICEISRCTN13914201EU-20613EUDRACT-2005-001710-40
• Study Type: interventional
• Target: 1,404
• Locations: 1 country
• Sites: 79

Brief 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.

Conditions

Breast Cancer; Hypercalcemia of Malignancy; Metastatic Cancer

Keywords

hypercalcemia of malignancy; stage IV breast cancer; bone metastases; recurrent breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (1)

• Frequency and timing of skeletal-related events (SREs)

  96 weeks

Secondary Outcomes (7)

• Time to first SREs

  96 Weeks

• Proportion of patients with SREs

  96 Weeks

• Pain and analgesic score

  96 weeks

• Quality of life

  96 weeks

• Toxicity

  96 weeks

Study Arms (2)

Ibandronic Acid

EXPERIMENTAL

50mg tablet once daily over 96 weeks

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

Drug: zoledronic acid; Drug: Zolendronic Acid

Interventions

ibandronate sodium DRUG

Ibandronic Acid

zoledronic acid DRUG

Zoledronic Acid

Zolendronic Acid DRUG

Zoledronic acid 4 mg by intravenous infusion every 4 weeks.

Also known as: Zoledronate

Zoledronic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wales Cancer Trials Unit: lead
• Velindre NHS Trust: collaborator

Study Sites (79)

William Harvey Hospital

Ashford, England, TN24 0LZ, United Kingdom

Location

North Devon District Hospital

Barnstaple, England, EX31 4JB, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Burnley General Hospital

Burnley, England, BB10 2PQ, United Kingdom

Location

Queen's Hospital

Burton-on-Trent, England, DE13 0RB, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT1 3NG, United Kingdom

Location

Broomfield Hospital

Chelmsford, Essex, England, CM1 7ET, United Kingdom

Location

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Countess of Chester Hospital

Chester, England, CH2 1UL, United Kingdom

Location

Essex County Hospital

Colchester, England, C03 3NB, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Darent Valley Hospital

Dartford Kent, England, DA2 8DA, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Dorset County Hospital

Dorchester, England, DT1 2JY, United Kingdom

Location

University Hospital of North Durham

Durham, England, DH1 5TW, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Queen Elizabeth Hospital

Gateshead, England, NE9 7UD, United Kingdom

Location

Diana Princess of Wales Hospital

Grimsby, England, DN33 2BA, United Kingdom

Location

Calderdale Royal Hospital

Halifax, England, HX3 0PW, United Kingdom

Location

University Hospital of Hartlepool

Hartlepool, Cleveland, England, TS24 9AH, United Kingdom

Location

Wycombe General Hospital

High Wycombe, England, HP11 2TT, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

Location

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, HU8 9HE, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L7 8XP, United Kingdom

Location

Whipps Cross Hospital

London, England, E11 1NR, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Macclesfield District General Hospital

Macclesfield, England, SK10 3BL, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Queen Elizabeth The Queen Mother Hospital

Margate, England, CT9 4AN, United Kingdom

Location

Clatterbridge Centre for Oncology

Metropolitan Borough of Wirral, England, CH63 4JY, United Kingdom

Location

St. Mary's Hospital

Newport, England, PO30 5TG, United Kingdom

Location

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

Location

King's Mills Hospital

Nottinghamshire, England, NG17 4JL, United Kingdom

Location

George Eliot Hospital

Nuneaton, England, CV10 7DJ, United Kingdom

Location

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

Location

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth, England, P03 6AD, United Kingdom

Location

Rosemere Cancer Centre at Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Alexandra Healthcare NHS

Redditch, Worcestershire, England, B98 7UB, United Kingdom

Location

Conquest Hospital

Saint Leonards-on-Sea, England, TN37 7RD, United Kingdom

Location

Scarborough General Hospital

Scarborough, England, YO12 6QL, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, England, ON15 7BH, United Kingdom

Location

Wexham Park Hospital

Slough, Berkshire, England, SL2 4HL, United Kingdom

Location

Solihull Hospital

Solihull, England, B91 2JL, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

University Hospital of North Tees

Stockton-on-Tees, England, TS19 8PE, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Torbay Hospital

Torquay Devon, England, TQ2 7AA, United Kingdom

Location

Royal Cornwall Hospital

Truro, Cornwall, England, TR1 3LJ, United Kingdom

Location

South Tyneside District Hospital

Tyne & Wear, England, NE34 0PL, United Kingdom

Location

Warrington Hospital NHS Trust

Warrington, England, WA5 1QG, United Kingdom

Location

South Warwickshire Hospital

Warwick, Warwickshire, England, CV34 5BW, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Royal Albert Edward Infirmary

Wigan, England, WN1 2NN, United Kingdom

Location

Royal Hampshire County Hospital

Winchester, England, SO22 5DG, United Kingdom

Location

Worcester Royal Hospital

Worcester, England, WR5 1AN, United Kingdom

Location

Yeovil District Hospital

Yeovil - Somerset, England, BA21 4AT, United Kingdom

Location

Hairmyres Hospital

East Kilbride, Scotland, G75 8RG, United Kingdom

Location

Falkirk and District Royal Infirmary

Falkirk, Scotland, FK1 5QE, United Kingdom

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Crosshouse Hospital

Kilmarnock, Scotland, KA2 OBE, United Kingdom

Location

Wishaw General Hospital

Wishaw, Scotland, ML2 0DP, United Kingdom

Location

Nevill Hall Hospital

Abergavenny, Wales, NP7 7EG, United Kingdom

Location

Bronglais District General Hospital

Aberystwyth, Wales, SY23 1ER, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

Princess of Wales Hospital

Bridgend, Wales, CF31 1JP, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

West Wales General Hospital

Carmarthen, Wales, SA31 2AF, United Kingdom

Location

Withybush General Hospital

Haverfordwest, Wales, SA61 2PZ, United Kingdom

Location

Prince Charles Hospital

Mid Glamorgan, Wales, CF47 9DT, United Kingdom

Location

Royal Gwent Hospital

Newport Gwent, Wales, NP20 2UB, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

South West Wales Cancer Institute

Swansea, Wales, SA2 8QA, United Kingdom

Location

Wrexham Maelor Hospital

Wrexham, Wales, LL13 7TD, United Kingdom

Location

Royal Glamorgan Hospital

Llantrisant, CF72 8XR, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 28274254 DERIVED

• 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.

  PMID: 24332514 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Humoral Hypercalcemia Of Malignancy; Neoplasm Metastasis; Breast Neoplasms, Male

Interventions

Ibandronic Acid; Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Peter J. Barrett Lee, MD

  Velindre NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2006
• First Posted: May 17, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: October 1, 2015
• Last Updated: March 13, 2013

Record last verified: 2013-03

Locations

GB (79)