Clinical trial NCT02716792: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-03-23
Enrollment: 334
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula
timeFrame: 28 days after last infusion (approximately 2 years)
Secondary outcomes:
measure: Number of Participants with Bone Pain According to Visual Analog Scale (VAS)
timeFrame: Every 3 weeks up to approximately 6 months
measure: Number of Participants With of Skeletal Events (Vertebral and Non-Vertebral Fractures, Impending Fracture, Radiotherapy or Surgery to Bone)
timeFrame: Up to approximately 7 months
measure: Percentage of Participants on Analgesics According to World Health Organization (WHO) Three-Step Analgesic Ladder
timeFrame: Up to approximately 7 months
measure: Karnofsky Index score
timeFrame: Every 3 weeks up to approximately 6 months
Other outcomes:
Locations:
city: Amboise
country: France
city: Angers
country: France
city: Bayonne
country: France
city: Besancon
country: France
city: Boulogne-billancourt
country: France
city: Brest
country: France
city: Chambery
country: France
city: Clermont Ferrand
country: France
city: Evreux
country: France
city: GAP
country: France
city: Hyeres
country: France
city: Le Chesnay
country: France
city: Metz Tessy
country: France
city: Nantes
country: France
city: Neuilly-sur-seine
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Saint Brieuc
country: France
city: Saint Gregoire
country: France
city: Saint Jean
country: France
city: Saint-cloud
country: France
city: Salouel
country: France
city: Strasbourg
country: France
city: Trappes
country: France
city: Valenciennes
country: France
city: Vandoeuvre Les Nancy
country: France
city: Villejuif
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: