A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer

Roche

Status and phase: Completed; Phase 4

Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis

Treatments: Drug: Ibandronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02553707

ML20268

Details and patient eligibility

About

This study will assess the short term efficacy of ibandronate (6 mg intravenous [IV]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.

Enrollment: 182 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female participants greater than or equal to (>=) 18 years of age
• Breast cancer with bone metastases
• Pain score of >=4 on Worst Pain scale of Brief Pain Inventory (BPI)
• Stable analgesic regimen.

Exclusion criteria

• Participants who have received a bisphosphonate within 3 weeks of start of trial
• Radiotherapy to bone within 4 weeks of enrolment
• Hypersensitivity to ibandronate
• Central nervous system (CNS) or meningeal metastases

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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182 participants in 1 patient group

Ibandronate

Experimental group

Description:

Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.

Treatment:

Drug: Ibandronate