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

Breast Cancer With Bone Metastasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00372710
• Other study ID #: CZOL446EDE03
• Status: Terminated
• Phase: Phase 3
• First received: September 6, 2006
• Last updated: November 20, 2009
• Start date: August 2002

Study information

• Verified date: November 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer With Bone Metastasis
• Breast Neoplasms

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of the safety, tolerability, and efficacy in the treatment arms