The target population for this trial are female patients with primary breast cancer with metastatic bone disease.
Conditions
Interventions
Trade Name: Bondronat 6mg/6ml
Product Name: Bondronat 6mg/6ml
Product Code: Ro 200-5450
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Ibandronic acid
Current Sponsor
Sponsors
Roche Pharma (Schweiz) AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria in order to be eligible for this study. 1. Written informed consent and willingness to participate to and comply with the study. 2. Female gender. 3. Age: = 18 years. 4. Histologically or cytologically confirmed breast cancer. 5. At least one osteolytic, mixed or blastic bone metastasis confirmed by X-ray, CT scan or MRI. The assessment is not necessary if it was done within 6 months prior to screening. 6. Metastases in other sites should be confirmed by X-ray, abdominal ultrasound or CT scan, if applicable. The assessment is not necessary if it was done within 6 months prior to screening. 7. WHO performance status of 0, 1 or 2 at screening. 8. If any bisphosphonate therapy is ongoing, the last dose has to be given = 3 weeks prior to start of study medication. 9. Antitumour therapies like chemotherapy, endocrine therapy or a therapy with Herceptin® are allowed, but should not be started at the same day as study medication. Patients not receiving any antineoplastic therapy are eligible providing they meet all other inclusion / exclusion criteria. 10. Adequate renal function at screening defined by serum creatinine value within normal limits (44.2-120 µmol/l; assessed by central laboratory) and by calculated creatinine clearance = 50 ml/min (Cockcroft-Gault; assessed by central laboratory). 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 meeting any one of the following criteria are not eligible for this study. 1. Life expectancy = 6 months. 2. Known hypersensitivity to ibandronate or other bisphosphonates. 3. Patients with unstable pathological renal function defined as serum creatinine value (> 120 µmol/l; assessed by central laboratory) or calculated creatinine clearance 3 times of standard therapy) within 6 months prior to start of study medication. 5. Nephrotoxic chemotherapies like Cisplatin and Methotrexat at study start. 6. Radiotherapy during the last 5 weeks. 7. Abdominal metastases with renal involvement. 8. Active infection of urinary tract at screening. Patient may have a screening once more after recovery. 9. Proteinuria > 0.5 g/l (assessed by local laboratory). 10. Uncontrolled hypercalcemia at study entry (serum calcium = 3.0 mmol/l (12.0 mg/dl) albumin-corrected). 11. Uncontrolled hypocalcemia at study entry (serum calcium = 1.8 mmol/l (7.2 mg/dl) albumin-corrected). 12. Actual treatment or treatment within the last 12 weeks prior to start of study medication with aminoglycoside antibiotics, antifungual antibiotics (i.e. Fungizone®) or any other known nephrotoxic medications. Diuretic agents must be stable within the last 4 weeks prior screening (patients with well controlled non-steroidal antirheumatic medication are eligible). 13. History of a psychological illness or medical condition such as to interfere with the patient's ability to understand the requirements of the study (i.e. brain metastases after treatment with any impact on cognitive function) as judged by the investigator. 14. Patient with organic (i.e. urinary incontinence) or mental disability to follow the instructions to collect 24 h urine sample as judged by the investigator. 15. Women lactating, pregnant, of childbearing potential or less than one year after menopause (unless surgically sterile) not using a reliable contraceptive method: intrauterine device, mechanical contraception (condom, diaphragm), oral, injectable or implanted contraceptives or total abstinence. Women of childbearing potential must have a negative pregnancy test (serum) at screening. 16. Patients who have received an investigational drug within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the renal safety of 6 mg ibandronate i.v. infusions over 15 min by estimating the percentage of patients with an increase of serum creatinine of = 44.2 µmol/l (= 0.5 mg/dl) from baseline. ;Secondary Objective: 1. To evaluate the absolute change in serum creatinine from baseline to last value available assessment. 2. To evaluate the relative % change in serum creatinine from baseline to last value available assessment. 3. To evaluate the relative % change in calculated and measured creatinine clearance from baseline to last value available assessment. 4. To evaluate the absolute change in calculated and measured creatinine clearance from baseline to last value available assessment. 5. Serum creatinine levels per cumulative dose of ibandronate. 6. To assess the absolute differences from baseline of tubular and glomerular markers: N-Acetyl-ß-D-glucosaminidase, a1-microglobulin, microalbuminuria. 7. To evaluate the efficacy on the reduction of bone pain, analgesic requirement and WHO performance status. 8. Number of infusions and cumulative dose in comparison in both groups. 9. To assess the safety and tolerability profile of ibandronate.;Primary end point(s): Percentage of patients with an increase of serum creatinine of = 44.2 µmol/l (= 0.5 mg/dl) from baseline. | — |
Countries
Germany
Outcome results
None listed