Clinical Trial: Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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 Tolerabil

Brief Summary:

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.


Detailed Summary:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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
    Sponsor: Wales Cancer Trials Unit

    Current Primary Outcome: Frequency and timing of skeletal-related events (SREs) [ Time Frame: 96 weeks ]

    Original Primary Outcome:

    Current Secondary Outcome:

    • Time to first SREs [ Time Frame: 96 Weeks ]
    • Proportion of patients with SREs [ Time Frame: 96 Weeks ]
    • Pain and analgesic score [ Time Frame: 96 weeks ]
    • Quality of life [ Time Frame: 96 weeks ]
    • Toxicity [ Time Frame: 96 weeks ]
    • Survival [ Time Frame: 5 years ]
    • Health resource usage and serum bone marker levels [ Time Frame: 96 weeks ]


    Original Secondary Outcome:

    Information By: Wales Cancer Trials Unit

    Dates:
    Date Received: May 16, 2006
    Date Started: January 2006
    Date Completion: October 2015
    Last Updated: March 12, 2013
    Last Verified: March 2013