Trial information
A Study to Assess the Short Term Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Metastatic Bone Pain due to Breast Cancer
Status: Recruiting
Protocol number: ML20268
Sponsor: Roche Hungary Ltd.
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the short term effect of intravenous loading doses of Bondronat on bone pain in patients with breast cancer and skeletal metastases experiencing moderate to severe pain
Brief summary: This study will assess the short term efficacy of Bondronat (6mg iv) in patients with breast cancer and malignant bone disease, with moderate to severe pain. All patients will receive an iv infusion of Bondronat on days 1, 2, and 3, and pain response will be measured on days 1-7. The anticipated time on study treatment in <3 months, and the target sample size is 100-500 individuals. Target sample size is
200.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Pain; Bone Neoplasms; Neoplasm Metastasis
Intervention type: Drug
Intervention name: ibandronate[Bondronat]
Primary outcome: 1. Pain response (>=25% decrease in mean pain score on days 5 to 7 compared to baseline, as determined by Worst Pain scale, with <=35% increase in mean analgesic consumption).
Key secondary outcomes: 1. Efficacy: Pain response on days 5 to 7, as determined by Average Pain scale; time to pain response; analgesic consumption. Safety: AEs, lab parameters, calculated creatinine clearance.
Inclusion criteria:
- female patients, >=18 years of age;
- breast cancer with bone metastases;
- pain score of >=4 on Worst Pain scale of BPI;
- stable analgesic regimen.
Exclusion criteria:
- patients who have received a bisphosphonate within 3 weeks of start of trial;
- radiotherapy to bone within 4 weeks of enrolment;
- hypersensitivity to Bondronat;
- CNS or meningeal metastases.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: August, 2006
Trial registration date: 08/16/2006
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Hungary
- Budapest
- Gyor
- Gyula
- Kecskemet
- Nyiregyhaza
- Szeged
- Szekesfehervar
- Szombathely
- Veszprem
- Zalaegerszeg
