OPEN LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS LOADING DOSE OF 3X 6MG IBANDRONIC ACID (BONDRONAT®) DURING 3 CONSECUTIVE DAYS IN PATIENTS WITH BREAST CANCER AND SKELETAL METASTASES EXPERIENCING MODERATE TO SEVERE PAIN - Bone Pain Experience Trial

Phase 1

Active, not recruiting

• Conditions: Metastasic bone pain in patients with breast cancer and bone metastases; MedDRA version: 8.1Level: PTClassification code 10006002Term: Bone pain

• Registration Number: EUCTR2006-003441-16-BE
• Lead Sponsor: .V. Roche S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-24
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified