Metastasic bone pain in patients with breast cancer and bone metastases MedDRA version: 8.1 Level: PT Classification code 10006002 Term: Bone pain
Conditions
Interventions
Trade Name: Bondronat 6mg, concentrate for solution for infusion
Product Name: Bondronat 6 mg
Product Code: Ro 200-5450/V34
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed I
Sponsors
N.V. Roche S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent - Age = 18 years - Histological or cytological evidence of breast cancer - Presence of bone metastases documented on bone X-ray, CT scan or MRI scan - Mean pain score = 4 during 3-day baseline period on the WORST pain scale of the BPI - Pain must correspond to areas of bone metastases, not to areas of visceral metastases e.g. liver metastases. - Minimum 3 weeks period after the last bisphosphonate treatment - No change in systemic anti-neoplastic therapy for at least 4 weeks prior to baseline period - Patients must be on a stable dose of, at least, a weak Opioid analgesic over the 3-day baseline period (maximum 10% variation is allowed) - ECOG Performance score of 0-3 (patients with PS of 3 must have their score based on bone pain, not underlying neoplastic disease) - Adequate renal function: creatinine clearance = 50ml/min (Cockroft formula) and serum creatinine =2.0mg/dl (168 µmol/L) - Normal serum calcium 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 an uncontrolled infection - Patients who have received a bisphosphonate within 3 weeks of the start of the Baseline period or who are currently receiving another bisphosphonate - Patients with WBC count = 1800/mm³ and/or platelet count = 75000/ mm³ - Patients with known hypersensitivity to any of the components of ibandronic acid - Patients who are pregnant or lactating - Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results. - Radiotherapy to bone within the 28 days prior inclusion or during the trial duration - Patient who are currently treated with any other investigational therapy or have received it within 30 days of the first schedule day of dosing (an investigational treatment is defined as one for which there is currently no regulatory-authority approved indication).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective to establish the efficacy in pain relief of ibandronic acid, loading dose, in patients with breast cancer and painful metastatic bone disease over a 7-day period. ;Secondary Objective: The secondary objective is to describe the safety and tolerance of ibandronic acid based on the monitoring of clinical laboratory results, especially serum creatinine level, creatinine clearance and on spontaneous reporting of adverse events.;Primary end point(s): The main efficacy endpoint is bone response. In this trial, pain response is defined as > 25% decrease in mean pain score of WORST PAIN over a 7-day period compared to the mean pain score of WORST PAIN over a 3-day baseline period as determined by the WORST PAIN scale of BPI (Brief Pain Inventory) with a maximum of 10% increase in mean Opioid analgesic consumption over the same 7-day period compared to mean Opioid analgesic consumption over the 3-day baseline period. The WORST pain score is defined as the bone pain which occurs on movement, during night or spontaneously for unknown reasons. | — |
Countries
Belgium
Outcome results
None listed