Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer That Has Spread to the Bone
RATIONALE: Zoledronate and ibandronate may prevent or help relieve bone pain and other symptoms caused by bone metastases. It is not yet known whether zoledronate is more effective than ibandronate in preventing bone problems caused by bone metastases due to breast cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to ibandronate in preventing bone problems in women with stage IV breast cancer that has spread to the bone.
Hypercalcemia of Malignancy
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||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|
- Skeletal-related events (SRE)
- Change in patient's rating of worst pain as measured by the Brief Pain Inventory
- Survival and time to first clinically apparent SRE
- Tolerability and toxicity as measured by NCI CTCAE v3.0
- Changes in performance status
|Study Start Date:||May 2006|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Other Name: zoledronic acidProcedure: quality-of-life assessment
Other Name: ibandronate sodiumProcedure: quality-of-life assessment
- 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 these drugs.
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 toxicity.
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.
|Study Chair:||Saul E. Rivkin, MD||Swedish Cancer Institute at Swedish Medical Center - First Hill Campus|
|Study Chair:||Kathy S. Albain, MD||Loyola University|
|Study Chair:||Dawn Hershman, MD||Herbert Irving Comprehensive Cancer Center|