Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients

Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases

The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skeletal metastases.

Painful skeletal metastases are a common site of advanced disease. For instance, in breast cancer, and despite cancer treatments (radiotherapy, cytotoxic treatment and adequate treatment of pain), the patients often need additional treatments that may relieve their symptoms. Bisphosphonates, such as ibandronic acid, have in pilot studies shown a significant decrease in pain scores, both after loading dose and after long-term treatment. In this study the safety and efficacy of an intravenous loading dose of three times 6 mg ibandronate during three consecutive days in breast cancer patients with painful skeletal metastases will be studied.

Inclusion Criteria:

• Breast cancer with presence of bone metastases
• Pain score over 4 on the VAS

Exclusion Criteria:

• Patients with pathological fractures or medulla compression or neuropathic pain
• Patients with infection or corticosteroid treatment
• Pregnant or lactating patients