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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborator: Novartis
• Treatments: Diphosphonates; Endothelial Growth Factors; Zoledronic Acid

Criteria

Inclusion Criteria:

• Signed informed consent

• Female, 18 years or older

• Histologically confirmed invasive breast cancer

• Bone metastases

• ECOG Performance Status of 0 to 2

• Life expectancy of more than 3 months

• Subject must have adequate organ function:

• Cr ≤ 3 mg/dL (265 µmol/L)，

• CrCl (Cockcroft & Gault) ≥ 30 mL/min，

• Ca2+ > 8.0 mg/dL (2.0 mmol/L) and ≤ 12 mg/dL (3.0 mmol/L)

• Negative serum pregnancy test for women with childbearing potential

• Good conditions for infusion and willing to undergo phlebotomy during the whole study

• Have ceased anti-tumor treatment including chemotherapy, endocrinotherapy and bio-targeted therapy for over 28 days

Exclusion Criteria:

• Pregnant or lactating females

• History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.

• Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety

• Active or uncontrolled infection

• Current active dental problems including infection of the teeth or jawbone (maxilla or mandible); dental or fixture trauma; or a current or prior diagnosis of osteonecrosis of the jaw (ONJ); or exposed bone in the mouth; or slow healing after dental procedures

• Recent (within 6 weeks of Randomization) or planned dental or jaw surgery (e.g. extraction, implants)

• Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure

• Concomitant with liver, brain or symptomatic lung metastases (symptoms such as hemoptysis, severe cough and shortness of breath)

• Accepted radiotherapy for solitary bone disease within 30 days before study

• Previous treatment with other bisphosphonates or radionuclides within one month before study

• Known hypersensitivity to bisphosphonates

• History of treatment with calcitonin, gallium nitrate or mithracin within 14 days before study.