NCT00524849

Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis

Randomized Phase 2 Study on the Relationship Between Circulating VEGF and Weekly or Every-four-week Zometa in Breast Cancer Patients With Bone Metastases

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effects of Zometa (zoledronic acid, 1 mg per week versus 4 mg every four weeks) on the circulating vascular endothelial growth factor (VEGF) levels in breast cancer patients with bone metastases. Sixty patients will be randomized into two groups.

Detailed description

The administration of Zometa in short intervals has been implied to be more potent in maximizing its antitumor and antiangiogenesis effects, while dosing every four weeks is an appropriate strategy for the prevention and management of bone metastases. This study was designed to explore the relationship between dosing of Zometa and level of circulating VEGF.

Conditions

• Metastatic Breast Cancer
• Bone Metastases

Interventions

Type	Name	Description
BIOLOGICAL	Zoledronic acid	Zometa 1 mg weekly (intravenous)
DRUG	Zoledronic acid	Zometa 4 mg every four weeks (intravenous)

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-08-01
• Completion: 2010-01-01
• First posted: 2007-09-05
• Last updated: 2010-09-14

Locations

1 site across 1 country: China