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

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ClinicalTrials.gov Identifier: NCT00372710
Recruitment Status : Terminated
First Posted : September 7, 2006
Last Update Posted : November 23, 2009
Sponsor:
Information provided by:
Novartis

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : August 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. Comparison of the safety, tolerability, and efficacy in the treatment arms


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372710


Locations
Germany
Freiburg, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis

ClinicalTrials.gov Identifier: NCT00372710     History of Changes
Other Study ID Numbers: CZOL446EDE03
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: November 23, 2009
Last Verified: November 2009

Keywords provided by Novartis:
Breast cancer
Palliation
Bone metastasis
Zoledronic acid

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs