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

Primary Purpose

Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
ibandronate sodium
zoledronic acid
Zolendronic Acid
Sponsored by
Wales Cancer Trials Unit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring hypercalcemia of malignancy, stage IV breast cancer, bone metastases, recurrent breast cancer, male breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • William Harvey Hospital
  • North Devon District Hospital
  • Royal Bournemouth Hospital
  • Burnley General Hospital
  • Queen's Hospital
  • Kent and Canterbury Hospital
  • Broomfield Hospital
  • Gloucestershire Oncology Centre at Cheltenham General Hospital
  • Countess of Chester Hospital
  • Essex County Hospital
  • Walsgrave Hospital
  • Darent Valley Hospital
  • Derbyshire Royal Infirmary
  • Dorset County Hospital
  • University Hospital of North Durham
  • Royal Devon and Exeter Hospital
  • Queen Elizabeth Hospital
  • Diana Princess of Wales Hospital
  • Calderdale Royal Hospital
  • University Hospital of Hartlepool
  • Wycombe General Hospital
  • Huddersfield Royal Infirmary
  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
  • Ipswich Hospital
  • Royal Liverpool University Hospital
  • Whipps Cross Hospital
  • Saint Bartholomew's Hospital
  • St. George's Hospital
  • Royal Marsden - London
  • Charing Cross Hospital
  • Macclesfield District General Hospital
  • Maidstone Hospital
  • Queen Elizabeth The Queen Mother Hospital
  • St. Mary's Hospital
  • King's Mills Hospital
  • Nottingham City Hospital
  • George Eliot Hospital
  • Peterborough Hospitals Trust
  • Dorset Cancer Centre
  • Portsmouth Oncology Centre at Saint Mary's Hospital
  • Rosemere Cancer Centre at Royal Preston Hospital
  • Alexandra Healthcare NHS
  • Conquest Hospital
  • Scarborough General Hospital
  • Scunthorpe General Hospital
  • Wexham Park Hospital
  • Solihull Hospital
  • Southampton General Hospital
  • University Hospital of North Tees
  • Royal Marsden - Surrey
  • Torbay Hospital
  • Royal Cornwall Hospital
  • South Tyneside District Hospital
  • Warrington Hospital NHS Trust
  • South Warwickshire Hospital
  • Southend University Hospital NHS Foundation Trust
  • Royal Albert Edward Infirmary
  • Royal Hampshire County Hospital
  • Clatterbridge Centre for Oncology
  • Worcester Royal Hospital
  • Yeovil District Hospital
  • Hairmyres Hospital
  • Falkirk and District Royal Infirmary
  • Western Infirmary
  • Crosshouse Hospital
  • Wishaw General Hospital
  • Nevill Hall Hospital
  • Bronglais District General Hospital
  • Ysbyty Gwynedd
  • Princess of Wales Hospital
  • Velindre Cancer Center at Velindre Hospital
  • West Wales General Hospital
  • Withybush General Hospital
  • Prince Charles Hospital
  • Royal Gwent Hospital
  • Glan Clwyd Hospital
  • South West Wales Cancer Institute
  • Wrexham Maelor Hospital
  • Royal Glamorgan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ibandronic Acid

Zoledronic Acid

Arm Description

50mg tablet once daily over 96 weeks

4 mg via intravenous infusion (iv) over a minimum of 15 minutes in at least 100mls of saline every 4 weeks over 96 weeks

Outcomes

Primary Outcome Measures

Frequency and timing of skeletal-related events (SREs)

Secondary Outcome Measures

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

Full Information

First Posted
May 16, 2006
Last Updated
March 12, 2013
Sponsor
Wales Cancer Trials Unit
Collaborators
Velindre NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00326820
Brief Title
Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wales Cancer Trials Unit
Collaborators
Velindre NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer
Keywords
hypercalcemia of malignancy, stage IV breast cancer, bone metastases, recurrent breast cancer, male breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1404 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibandronic Acid
Arm Type
Experimental
Arm Description
50mg tablet once daily over 96 weeks
Arm Title
Zoledronic Acid
Arm Type
Active Comparator
Arm Description
4 mg via intravenous infusion (iv) over a minimum of 15 minutes in at least 100mls of saline every 4 weeks over 96 weeks
Intervention Type
Drug
Intervention Name(s)
ibandronate sodium
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Intervention Type
Drug
Intervention Name(s)
Zolendronic Acid
Other Intervention Name(s)
Zoledronate
Intervention Description
Zoledronic acid 4 mg by intravenous infusion every 4 weeks.
Primary Outcome Measure Information:
Title
Frequency and timing of skeletal-related events (SREs)
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
Time to first SREs
Time Frame
96 Weeks
Title
Proportion of patients with SREs
Time Frame
96 Weeks
Title
Pain and analgesic score
Time Frame
96 weeks
Title
Quality of life
Time Frame
96 weeks
Title
Toxicity
Time Frame
96 weeks
Title
Survival
Time Frame
5 years
Title
Health resource usage and serum bone marker levels
Time Frame
96 weeks

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
28274254
Citation
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.
Results Reference
derived
PubMed Identifier
24332514
Citation
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. Erratum In: Lancet Oncol. 2014 Feb;15(2):e52-3.
Results Reference
derived

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

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