A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer
Primary Purpose
Pain; Bone Neoplasms; Neoplasm Metastasis
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ibandronate
Sponsored by
About this trial
This is an interventional treatment trial for Pain; Bone Neoplasms; Neoplasm Metastasis
Eligibility Criteria
Inclusion Criteria:
- For participants of childbearing potential: negative pregnancy test and ready to use effective contraceptive measures
- Metastatic breast cancer with at least one bone metastasis
- Karnofsky index >/= 60
- Life expectancy >/= 6 months
- Estimated creatinine clearance (Cockcroft and Gault formula) >/= 30 milliliters per minute (mL/min)
Exclusion Criteria:
- Pregnancy or breast feeding participant
- Participant who had a current dental problem, particularly tooth or jaw infection, trauma or surgery on tooth or jaw in the previous six weeks, medical history of jaw osteonecrosis or delayed healing after dental surgery
- Participant who was participating or had participated in the last 30 days to a clinical trial investigating treatments
- Uncontrolled brain metastasis
- Severe or concomitant infection
- Known medical history of systemic disease with renal lesion
- Rapidly progressing renal failure at inclusion
- Uncontrolled cardiac disorder
- Hypercalcaemia (> 2.7 millimoles per liter [mmol/L]), hypocalcaemia (< 2 mmol/L)
- Participant receiving nephrotoxic chemotherapy
- Participant eligible for haematopoietic stem cell transplantation at inclusion time
- Bisphosphonate therapy in the 3 weeks before randomization
- Known hypersensitivity to ibandronate or other bisphosphonates
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ibandronate 15-Minute Infusion
Ibandronate 60-Minute Infusion
Arm Description
Participants will receive ibandronate IV infusions over a 15-minute interval.
Participants will receive ibandronate IV infusions over a 60-minute interval.
Outcomes
Primary Outcome Measures
Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula
Secondary Outcome Measures
Number of Participants with Bone Pain According to Visual Analog Scale (VAS)
Number of Participants With of Skeletal Events (Vertebral and Non-Vertebral Fractures, Impending Fracture, Radiotherapy or Surgery to Bone)
Percentage of Participants on Analgesics According to World Health Organization (WHO) Three-Step Analgesic Ladder
Karnofsky Index score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02716792
Brief Title
A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer
Official Title
Randomized, Open Label Study to Evaluate Renal Safety of Intravenous Bondronat 6 mg Infusions Over 15 Minutes Versus 60 Minutes in Patients With Metastatic Bone Disease Due to Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This study will evaluate renal function in participants with metastatic bone disease due to breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of ibandronate in the 2 groups of participants will also be compared. The anticipated time on study treatment is 7 months, and the target sample size is 318 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain; Bone Neoplasms; Neoplasm Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibandronate 15-Minute Infusion
Arm Type
Experimental
Arm Description
Participants will receive ibandronate IV infusions over a 15-minute interval.
Arm Title
Ibandronate 60-Minute Infusion
Arm Type
Active Comparator
Arm Description
Participants will receive ibandronate IV infusions over a 60-minute interval.
Intervention Type
Drug
Intervention Name(s)
Ibandronate
Other Intervention Name(s)
Bondronat
Intervention Description
Participants will receive ibandronate, 6 mg via IV infusion, every 3 weeks for up to 9 cycles. The infusion interval will be either 15 or 60 minutes depending upon treatment group assignment every 3 weeks (9 treatment cycles in total).
Primary Outcome Measure Information:
Title
Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula
Time Frame
28 days after last infusion (approximately 2 years)
Secondary Outcome Measure Information:
Title
Number of Participants with Bone Pain According to Visual Analog Scale (VAS)
Time Frame
Every 3 weeks up to approximately 6 months
Title
Number of Participants With of Skeletal Events (Vertebral and Non-Vertebral Fractures, Impending Fracture, Radiotherapy or Surgery to Bone)
Time Frame
Up to approximately 7 months
Title
Percentage of Participants on Analgesics According to World Health Organization (WHO) Three-Step Analgesic Ladder
Time Frame
Up to approximately 7 months
Title
Karnofsky Index score
Time Frame
Every 3 weeks up to approximately 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
For participants of childbearing potential: negative pregnancy test and ready to use effective contraceptive measures
Metastatic breast cancer with at least one bone metastasis
Karnofsky index >/= 60
Life expectancy >/= 6 months
Estimated creatinine clearance (Cockcroft and Gault formula) >/= 30 milliliters per minute (mL/min)
Exclusion Criteria:
Pregnancy or breast feeding participant
Participant who had a current dental problem, particularly tooth or jaw infection, trauma or surgery on tooth or jaw in the previous six weeks, medical history of jaw osteonecrosis or delayed healing after dental surgery
Participant who was participating or had participated in the last 30 days to a clinical trial investigating treatments
Uncontrolled brain metastasis
Severe or concomitant infection
Known medical history of systemic disease with renal lesion
Rapidly progressing renal failure at inclusion
Uncontrolled cardiac disorder
Hypercalcaemia (> 2.7 millimoles per liter [mmol/L]), hypocalcaemia (< 2 mmol/L)
Participant receiving nephrotoxic chemotherapy
Participant eligible for haematopoietic stem cell transplantation at inclusion time
Bisphosphonate therapy in the 3 weeks before randomization
Known hypersensitivity to ibandronate or other bisphosphonates
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Amboise
ZIP/Postal Code
37403
Country
France
City
Angers
ZIP/Postal Code
49933
Country
France
City
Bayonne
ZIP/Postal Code
64100
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Boulogne-billancourt
ZIP/Postal Code
92100
Country
France
City
Brest
ZIP/Postal Code
29609
Country
France
City
Chambery
ZIP/Postal Code
73011
Country
France
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
City
Evreux
ZIP/Postal Code
27000
Country
France
City
GAP
ZIP/Postal Code
05007
Country
France
City
Hyeres
ZIP/Postal Code
83400
Country
France
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
City
Metz Tessy
ZIP/Postal Code
74370
Country
France
City
Nantes
ZIP/Postal Code
44202
Country
France
City
Neuilly-sur-seine
ZIP/Postal Code
92200
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Paris
ZIP/Postal Code
75674
Country
France
City
Paris
ZIP/Postal Code
75970
Country
France
City
Rennes
ZIP/Postal Code
35042
Country
France
City
Rouen
ZIP/Postal Code
76000
Country
France
City
Saint Brieuc
ZIP/Postal Code
22015
Country
France
City
Saint Gregoire
ZIP/Postal Code
35768
Country
France
City
Saint Jean
ZIP/Postal Code
31240
Country
France
City
Saint-cloud
ZIP/Postal Code
92210
Country
France
City
Salouel
ZIP/Postal Code
80480
Country
France
City
Strasbourg
ZIP/Postal Code
67010
Country
France
City
Trappes
ZIP/Postal Code
78190
Country
France
City
Valenciennes
ZIP/Postal Code
59322
Country
France
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
City
Villejuif
ZIP/Postal Code
94804
Country
France
12. IPD Sharing Statement
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A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer
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