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SCCA Breast Cancer Clinical Trials

Zoledronic Acid for Bone Metastases From Breast Cancer (6979)
A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Zometa® ) (Every 4 Weeks vs. Every 12 Weeks) in Patients With Documented Bone Metastases From Breast Cancer
Status Conditions Phase Study ID
Closed Breast Cancer Phase III 6979
NCT00320710
Summary

Clinical trial in breast cancer patients with bone metastases pretreated with zoledronic acid. Looking at the effectiveness of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.


Investigator
Georgiana Ellis, MD
Location    
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
Criteria

Inclusion Criteria:

  • Female patients ≥ 18 years of age
  • Confirmed breast cancer with bone metastasis.
  • Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses.

Exclusion Criteria:

  • Abnormal kidney function determined by serum creatinine levels.
  • Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw.
  • Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants)
  • Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone)
  • Known hypersensitivity to Zometa
  • Treatment with other investigational drugs within 30 days prior to randomization.

Other protocol-defined exclusion criteria may apply.

 

Last Updated
July 25, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.