Metastatic bone disease related metastatic bone pain with breast as the primary site.
Conditions
Interventions
Trade Name: Bondronat®
Product Name: Bondronat 6mg/6ml
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ibandronic acid
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Roche (Hellas) S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with breast cancer and metastatic disease to bone - Mean Worst pain score on BPI = 4 over a baseline period of 3 consecutive days - Stable dose of analgesics over the 3-day baseline period, variation in daily dose remains below 25% - Creatinine Clearance = 50 ml/min - Karnofsky index > 50% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with impending pathological fracture defined as a greater than 50% involvement of a weight bearing bone by malignancy with a lytic or mixed lytic/blastic appearance - Patient with change in the type of systemic anti-neoplastic therapy for at least 6 weeks prior to baseline period - Patients who have received a bisphosphonate within 3 weeks from the signing of informed consent however, use of bisphosphonates prior to this period is permitted - Patients with known hypersensitivity to any of the components of ibandronic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of loading doses of ibandronic acid in patients with breast cancer and metastatic bone disease and moderate to severe bone pain. The main efficacy endpoint is bone pain response.;Secondary Objective: - Safety assessment will be based on the monitoring of clinical laboratory results and on adverse event recording - Mean Worst pain scale of the Brief Pain Inventory over the first 7 days - Analgesic consumption expressed as opioid equivalents - Karnofsky index;Primary end point(s): The main efficacy endpoint is bone pain response: 20% decrease in mean pain score over a 3-day period (day 5, 6, 7) compared to mean pain score over a 3-day period prior to baseline as determined by the Worst pain scale of the Brief Pain Inventory (BPI), with no more than 50% increase in mean analgesic consumption over the same 3-day period compared to mean analgesic consumption over the 3-day period prior to baseline. | — |
Countries
Greece
Outcome results
None listed