Patients with Breast Cancer and Skeletal Metastases Experiencing Moderate to Severe Pain MedDRA version: 9.1 Level: LLT Classification code 10049038 Term: Metastatic bone pain
Conditions
Interventions
Trade Name: Bondronat
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ibandronic acid
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concen
Sponsors
Roche (Hungary) Ltd.
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 • Pain score of > 4 on the WORST PAIN scale of BPI. • Bone pain must correspond to areas of metastases on bone x-ray, bone scintigram, CT scan or MRI scan; • Age > 18 years • WHO Performance Score of 0 – 3 • Adequate renal function as evidenced by a calculated creatinine clearance > 50 mL/min by Cockcroft-Gault method. • Normal serum calcium level • Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial. • By clinical judgement of investigator, the prescribed analgesic therapy of the patient is stable, and, as foreseen at inclusion, it will not require modification during the 7 days of the trial. 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 active infection or with a fever > 38.50 C within 3 days of the first scheduled day of dosing • Patients with an impending pathological fracture (erosion of at least 1/3 of the cortex by neoplastic process) • Patients with known untreated CNS or meningeal metastases • Patients who have received a bisphosphonate within 3 weeks of the start of the trial; however, use of bisphosphonates prior to this period IS PERMITTED • Patients with known hypersensitivity to any of the components of ibandronic acid • Radiotherapy to bone within 4 weeks of enrolment • Patients with Paget’s disease of bone • 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 to interfere with the interpretation of the results. • Patient 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. “Investigational therapy” does not refer to approved agents used in a clinical trial in an off-label manner, e.g., in a different dose or schedule, or in a non-approved tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary endpoints will consist of • Pain response as defined above determined by the “AVERAGE PAIN” scale of the BPI • Time to pain response based on the WORST PAIN scale of the BPI • Analgesic consumption expressed as opioid equivalents • WHO Performance Score • Interference Scales of the BPI • Patient Global Assessment ;Main Objective: The primary objective is to establish the pain response of the treatment with ibandronic acid in patients with Breast cancer and painful metastatic bone disease. In this study, pain response is defined as a: = 25% decrease in mean pain score on days 5 to 7 compared to mean pain score at baseline as determined by the “WORST PAIN” scale of the Brief Pain Inventory (BPI), with no more than a 35% increase in mean analgesic consumption in the observation phase compared to mean baseline analgesic consumption. ;Primary end point(s): The main efficacy endpoint is bone pain response. In this study, pain response is defined as a: = 25% decrease in mean pain score on days 5 to 7 compared to mean pain score at baseline as determined by the “WORST PAIN” scale of the Brief Pain Inventory (BPI), with no more than a 35% increase in mean analgesic consumption on days 5 to 7 compared to mean baseline analgesic consumption. | — |
Countries
Hungary
Outcome results
None listed