A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will assess the short term efficacy of ibandronate (6 mg intravenous [IV]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Diphosphonates; Ibandronic Acid

Criteria

Inclusion Criteria:

• Female participants greater than or equal to (>=) 18 years of age

• Breast cancer with bone metastases

• Pain score of >=4 on Worst Pain scale of Brief Pain Inventory (BPI)

• Stable analgesic regimen.

Exclusion Criteria:

• Participants who have received a bisphosphonate within 3 weeks of start of trial

• Radiotherapy to bone within 4 weeks of enrolment

• Hypersensitivity to ibandronate

• Central nervous system (CNS) or meningeal metastases