A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer
NCT ID: NCT02716792
Last Updated: 2016-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
334 participants
INTERVENTIONAL
2006-01-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ibandronate 15-Minute Infusion
Participants will receive ibandronate IV infusions over a 15-minute interval.
Ibandronate
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).
Ibandronate 60-Minute Infusion
Participants will receive ibandronate IV infusions over a 60-minute interval.
Ibandronate
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).
Interventions
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Ibandronate
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Amboise, , France
Angers, , France
Bayonne, , France
Besançon, , France
Boulogne-Billancourt, , France
Brest, , France
Chambéry, , France
Clermont-Ferrand, , France
Évreux, , France
Gap, , France
Hyères, , France
Le Chesnay, , France
Metz-Tessy, , France
Nantes, , France
Neuilly-sur-Seine, , France
Paris, , France
Paris, , France
Paris, , France
Rennes, , France
Rouen, , France
Saint-Brieuc, , France
Saint-Cloud, , France
Saint-Grégoire, , France
Saint-Jean, , France
Salouël, , France
Strasbourg, , France
Trappes, , France
Valenciennes, , France
Vandœuvre-lès-Nancy, , France
Villejuif, , France
Countries
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Other Identifiers
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ML19188
Identifier Type: -
Identifier Source: org_study_id
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