Assessment of Tartrate-Resistant Acid Phosphatase (TRAP) as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis

Inclusion criteria

• Histologic or cytologic documentation of breast cancer.
• Stage IV Breast Cancer Patients with bone metastasis for whom Zometa treatment will be initiated.
• Age > 18
• Written informed consent prior to study entry
• Patients may be currently receiving hormone therapy, chemotherapy and/or radiation therapy to the primary tumor.
• Life expectancy of at least 6 months.
• We will include patients who have had previous or current radiation therapy to breast

Exclusion criteria

• Concurrent malignancy with a second primary
• Stage I, Stage II and Stage III
• ECOG Performance Status 3 or 4.
• Renal Failure - serum creatinine >2.O mg/dL at screening
• AST or ALT > ULN X 3. at screening
• Bilirubin > 3.0 mg/dL at screening
• Pregnant women
• Prior or current bisphosphonate therapy
• Any skeletal related event due to malignancy prior to study enrollment.
• Patients with osteoporotic fractures prior to study enrollment.
• Allergy to bisphosphonates
• Any radiation therapy for the treatment of bone metastases <4 weeks prior to study start.
• Any chronic medical condition which would preclude performance or adherence to protocol requirements
• Inability to provide informed consent

-