Back to resultsSafety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions
Primary Purpose
Breast Cancer With Bone Metastasis
Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer With Bone Metastasis focused on measuring Breast cancer, Palliation, Bone metastasis, Zoledronic acid
Eligibility 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)
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00372710
Brief Title
Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions
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 Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Terminated
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer With Bone Metastasis
Keywords
Breast cancer, Palliation, Bone metastasis, Zoledronic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Comparison of the safety, tolerability, and efficacy in the treatment arms
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
City
Freiburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions
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