Prospective, multicenter study to evaluate the renal safety of 6 mg ibandronic acid infusions over 15 min or 60 min in patients with metastatic bone disease due to breast cancer.

Conditions: The target population for this trial are female patients with primary breast cancer with metastatic bone disease.

Registration Number: EUCTR2005-000535-18-DE

Lead Sponsor: Roche Pharma (Schweiz) AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 130

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

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 < 50 ml/min (Cockcroft-Gault; assessed by central laboratory) within the last 3 months.
4. High-dose chemotherapy (i.e. dose intensity > 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.