A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.
This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Drug: ibandronate [Bondronat]
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Metastatic Bone Pain in Patients With Breast Cancer and Skeletal Metastases.|
- Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption [ Time Frame: Days 5 - 7 ] [ Designated as safety issue: No ]
- Mean worst pain score over first 7 days [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
- Analgesic consumption [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
- Karnofsky index [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
- AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
|Estimated Study Completion Date:||January 2008|
|Study Director:||Clinical Trials||Hoffmann-La Roche|