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

NCT ID: NCT00372710

Last Updated: 2009-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer With Bone Metastasis

Keywords

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Breast cancer Palliation Bone metastasis Zoledronic acid

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zoledronic acid

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: STUDY_CHAIR

Novartis

Locations

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Freiburg im Breisgau, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CZOL446EDE03

Identifier Type: -

Identifier Source: org_study_id