Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients

Study Overview
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Brief Summary
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to evaluate whether bone marker can provide the valuable predictor of skeletal complications and whether regular assessing of NTX(N-telopeptide of type I collagen) and osteocalcin can be useful in advanced breast cancer patients with bone metastasis receiving zoledronic acid.

Detailed Description
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to evaluate the efficacy and safety of zoledronic acid by measuring changes in bone turnover markers the incidence of skeletal-related events time to skeletal-related events time to bone metastases progression overall survival the incidence of each adverse event including osteonecrosis

Official Title
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A Phase IV, Multi-center, Open Label, Single Arm Clinical Trial to Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: zoledronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced breast cancer with radiographic confirmation of bone metastases (minimum of one bone scan lesion must be confirmed as metastatic on plain radiographs or CT/MR imaging) Men or women aged ≥ 18 years WHO (ECOG) performance status 0-2 Women of child-bearing potential must be using a reliable and appropriate method of contraception Urine sample taken and sent to the central laboratory for baseline Ntx analysis Written informed consent. Exclusion Criteria: Bisphosphonate treatment within the 4 weeks prior to planned first study treatment Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute Poor venous access Metabolic bone disease Unable to comply with study procedures, especially the reliable collection of urine samples for bone resorption marker measurements Estimated life expectancy of < 6 months Treatment with systemic bone seeking radioisotopes within the 3 months prior to study entry Wide field (hemi-body) radiotherapy within the 3 months prior to study entry Concomitant medication with drugs known to affect bone metabolism Pregnancy or breast-feeding Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular), or a current or prior diagnosis of osteonecrosis of the jaw (ONJ) Recent (within 4 weeks of study entry*) or planned dental or jaw surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoledronic acid<br>Patients with advanced breast cancer with radiographic confirmation of bone metastases. This arm will be receiving zoledronic acid administration. The primary endpoint is to find the correlation between bone turnover markers and the frequency of skeletal-related-events for one year. Skeletal related events are defined as pathologic fractures, the need for radiation therapy, orthopaedic surgery, hypercalcemia of malignancy and spinal cord compression. A total of 237 patients will be included. | Drug: zoledronic acid<br>* Intravenous zoledronic acid 4mg over a minimum of 15 minutes in at least 100mls of calcium free infusion solution (0.9% sodium chloride or 5% glucose solution) every 4 weeks.<br>* Other names: ZOMETA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary NTX and serum osteocalcin will be assessed at baseline, 3, 6, 9, and 12 months and when unexpected skeletal related events is detected. |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic breast cancer, bone remodeling markers, zoledronic acid