Trial Information

Summary: Breast Cancer Study CZOL446E2352

Novartis Oncology is conducting a study to find out if zoledronic acid is safe and effective for women who have been taking zoledronic acid for the past year and have breast cancer that has spread to the bone. The reason for this study is to find out whether zoledronic acid continues to decrease skeletal-related events (like breaking bones) after 9-20 doses during the previous 10 to 15 months. If it does continue to decrease them, then the study will examine which dose is better between treatment once a month or once every three months. If you agree to join this study you will be assigned randomly to one of three treatment groups which includes a treatment discontinuation group where participants will be required to have an infusion that contains no medicine. The study drug will be given to participants by intravenous infusion. Zoledronic acid is currently approved in the United States for cancer participants with Hypercalcemia of Malignancy (high calcium in the blood from cancer) and for treatment of cancer participants with multiple myeloma (a blood cancer). Zoledronic acid has also been approved for participants with confirmed bone mestastases (cancer that has spread to the bone) from other solid tumors (like breast cancer) to prevent skeletal related events. The FDA approval in the United States for participants with bone metastases is for zoledronic acid to be used for 12 months. This study will also look at how safe zoledronic acid is after one year.

15 visits to the study center over the 13 months, and the visits should last about 2 hours.
For more information about this clinical trial, visit www.NovartisClinicalTrials.com

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Trial listings updated: June 27, 2008 at 1:00:25 PM