Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Zoledronic acid selectively binds to bone and protects it from being metastasized by tumor cells. This study evaluates the safety and efficacy of zoledronic acid when added to standard therapies in breast cancer patients with metastatic bone lesions.

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

Details

• Lead Sponsor: Novartis
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion criteria

• Confirmed diagnosis of Breast Cancer with at least one breast cancer-related bone lesion

• No treatment with bisphosphonates within 6 months prior to inclusion into the study

• Good health status (ECOG Performance status 0-2)

Exclusion criteria

• Patients who do not have at least one breast cancer-related bone lesion that is detectable on conventional radiographs of bone (plain film) at screening

• Abnormal renal function

• History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism

• Pregnancy and lactation

• Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g..extraction, implants)