Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer
RATIONALE: Ibandronate and zoledronate may help relieve some of the symptoms caused by bone metastases. It is not yet know whether ibandronate is more effective than zoledronate in treating bone metastases from breast cancer.
PURPOSE: This randomized phase III trial is studying ibandronate to see how well it works compared with zoledronate in treating patients with newly diagnosed bone metastases from breast cancer.
Hypercalcemia of Malignancy
Drug: ibandronate sodium
Drug: zoledronic acid
Drug: Zolendronic Acid
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Zoledronate Versus Ibandronate Comparative Evaluation: A Randomized Phase III, Open-Label, Multicenter, Parallel Group Clinical Trial to Evaluate and Compare the Efficacy, Safety Profile and Tolerability of Oral Ibandronate Versus Intravenous Zoledronate in the Treatment of Breast Cancer Patients With Bone Metastases|
- Frequency and timing of skeletal-related events (SREs) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- Time to first SREs [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
- Proportion of patients with SREs [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
- Pain and analgesic score [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
- Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Health resource usage and serum bone marker levels [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||October 2015|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Ibandronic Acid
50mg tablet once daily over 96 weeks
|Drug: ibandronate sodium|
Active Comparator: Zoledronic Acid
4 mg via intravenous infusion (iv) over a minimum of 15 minutes in at least 100mls of saline every 4 weeks over 96 weeks
Drug: zoledronic acid
Drug: Zolendronic Acid
Zoledronic acid 4 mg by intravenous infusion every 4 weeks.
Other Name: Zoledronate
- Compare the efficacy, in terms of reducing frequency and timing of skeletal-related events (SREs), of ibandronate vs zoledronate in patients with newly diagnosed bone metastases secondary to breast cancer.
- Compare the median time to first SRE in patients treated with these regimens.
- Compare the percentage of patients experiencing a SRE after treatment with these regimens.
- Compare the number of occult vertebral fractures present in patients at the end of treatment with these regimens.
- Compare the pain and analgesic scores and quality of life of patients treated with these regimens.
- Compare the number of patients developing renal dysfunction or hypocalcemia during the study period.
- Compare the number of patients developing osteonecrosis of the jaw during study treatment and follow-up.
- Compare the overall survival of these patients at 96 weeks and at 5 years.
- Compare the health-resource usage of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, parallel-group, controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive zoledronate IV over 15 minutes on day 1. Treatment repeats every 21* or 28 days for at least 96 weeks (24 or 32 courses) in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients who receive concurrent chemotherapy every 3 weeks receive study treatment every 21 days
- Arm II: Patients receive oral ibandronate once daily on days 1-28. Treatment repeats every 28 days for at least 96 weeks (24 courses) in the absence of disease progression or unacceptable toxicity. Patients with bone pain or hypercalcemia at study entry or those who require IV therapy due to hypercalcemia while on study may receive 1 treatment with ibandronate IV at the discretion of the supervising clinician.
Quality of life and pain are assessed at baseline, after every 3 courses, and at completion of study treatment.
After completion of study treatment, patients are followed annually for up to 3 years.
PROJECTED ACCRUAL: A total of 1,400 patients will be accrued for this study.
Show 79 Study Locations
|Study Chair:||Peter J. Barrett Lee, MD||Velindre NHS Trust|