A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer

Roche

Status and phase: Completed; Phase 3

Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis

Treatments: Drug: Ibandronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02716792

ML19188

Details and patient eligibility

About

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.

Enrollment: 334 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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334 participants in 2 patient groups

Ibandronate 15-Minute Infusion

Experimental group

Description:

Participants will receive ibandronate IV infusions over a 15-minute interval.

Treatment:

Drug: Ibandronate

Ibandronate 60-Minute Infusion

Active Comparator group

Description:

Participants will receive ibandronate IV infusions over a 60-minute interval.

Treatment:

Drug: Ibandronate