Treatment of pain in breast cancer patients with bone metastases
Conditions
Interventions
Trade Name: Bondronat 6mg/6ml
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
The BONiFIN study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histological or cytological evidence of breast cancer - Presence of bone metastases documented on bone x-ray, bone scintigram, CT scan or MRI scan before inclusion into the trial. - Worst pain score in movement or in rest of = 4 on the VAS during the previous 24 hours before the Screening visit. - After the optimization of the analgesic dose worst pain score in movement or in rest of = 4 on the VAS during the previous 24 hours before the visit on Day 1. - Bone pain must correspond to areas of metastases on bone x-ray, bone scintigram, CT scan or MRI scan; patients, whose pain is primarily due to visceral disease (e.g., liver metastases) or to neuropathy should be excluded. It is the responsibility of the investigator to ensure that each patient’s pain is primarily due to bone metastases. - The use of at least a weak opioid based on the WHO analgesic ladder (Appendix 7) during the baseline period 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with an active infection or with a fever > 38.50 C within 3 days of the first scheduled day of ibandronate dosing • Patients with an impending pathological fracture • Patients with known medulla compression. • Patients, who have received an intravenous bisphosphonate within 4 weeks before baseline/screening. • Patients with known hypersensitivity to any of the components of ibandronate • Patients, who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of dosing; investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication in any country.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the Pain Response of ibandronic acid on day 7 compared to baseline in breast cancer patients with painful bone metastases. ;Secondary Objective: Secondary variables: - worst pain in movement and rest on NRS - average pain in movement and rest on VAS and NRS - worst and average pain in movement and in rest on VAS recorded in a diary -consumption of analgesics recorded in a diary Quality of life variables - WHO PS - EORTC QLQ C30 Safety variables - Adverse Events ;Primary end point(s): Pain variables Primary variable: - worst pain in movement and rest on VAS | — |
Countries
Finland
Outcome results
None listed