A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.
Phase 2
Withdrawn
- Conditions
- PainNeoplasm MetastasisBone Neoplasm
- Interventions
- Registration Number
- NCT00478270
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- adult patients, >=18 years of age;
- breast cancer;
- bone metastases;
- mean worst pain score >=4 during 3 day baseline period;
- stable dose of analgesics over a 3 day baseline period;
- adequate renal function.
Exclusion Criteria
- bisphosphonate treatment within 3 weeks of study enrollment;
- a change in antineoplastic treatment within 6 weeks of study enrollment;
- bone radiation within 2 weeks of study enrollment;
- active infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 ibandronate [Bondronat] -
- Primary Outcome Measures
Name Time Method Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption Days 5 - 7
- Secondary Outcome Measures
Name Time Method Analgesic consumption Day 7 Mean worst pain score over first 7 days Day 7 Karnofsky index Day 7 AEs, laboratory parameters Throughout study