Status:
UNKNOWN
Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients
Lead Sponsor:
Korean Breast Cancer Study Group
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 adv...
Detailed Description
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 metast...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT00912938
Start Date
December 1 2007
End Date
December 1 2010
Last Update
February 17 2010
Active Locations (1)
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1
Department of Surgery, Korea University Guro Hospital
Seoul, South Korea