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

Sponsor

Novartis (Industry)

Overall Status

Terminated

CT.gov ID

NCT00372710

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer With Bone Metastasis	Drug: Zoledronic acid	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Tolerability of Intravenous Zoledronic Acid 4mg as an Adjunct to Standard Therapies Including Conversion From Pamidronate in Breast Cancer Patients With Metastatic Bone Lesions. A Prospective, Randomised, Open-label, Clinical Study

Study Start Date :

Aug 1, 2002

Outcome Measures

Primary Outcome Measures

Efficacy of a switch over from pamidronate therapy (2 infusions) to a treatment with zoledronic acid 4mg every 4 weeks (10 infusions) for 44 weeks in patients with breast cancer-related bone lesions []

Secondary Outcome Measures

Comparison of the safety, tolerability, and efficacy in the treatment arms []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)