A Phase III Randomized, Multicenter Non-Inferiority Trial Evaluating the Efficacy of Oral Ibandronate Versus Intravenous Zoledronate in the Reduction of Skeletal-Related Events in Patients With Metastatic Breast Cancer
- Compare the efficacy of zoledronate vs ibandronate, in terms of preventing the
occurrence of skeletal-related events (SRE) (e.g., fracture, spinal cord compression,
radiotherapy or surgery for bone symptoms or events, or hypercalcemia ≥ grade 3), in
women with stage IV breast cancer and bone metastases.
- Compare the change in patient-reported measures of pain and use of analgesics in
patients treated with these drugs.
- Compare the time to first clinically apparent SRE in patients treated with these drugs.
- Compare the toxicity of these drugs.
- Compare the changes in performance status and overall survival of patients treated with
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
hormone receptor status (estrogen receptor [ER] and progesterone receptor [PR] negative vs
ER and/or PR positive) and current evidence of fracture (vertebral or nonvertebral) or
spinal compression (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral ibandronate once daily on days 1-28.
- Arm II: Patients receive zoledronate IV over 15 minutes on day 1. In both arms,
treatment repeats every 28 days for up to 18 courses in the absence of unacceptable
Quality of life and pain are assessed at baseline, every 3 courses during study treatment,
and at the end of study treatment.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 488 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Skeletal-related events (SRE)
Saul E. Rivkin, MD
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
United States: Federal Government