This trial is active, not recruiting.

Condition metastatic breast cancer
Treatment zoledronic acid
Phase phase 4
Sponsor Korean Breast Cancer Study Group
Start date December 2007
End date December 2010
Trial size 237 participants
Trial identifier NCT00912938, KBCSG001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
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.
zoledronic acid ZOMETA
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.

Primary Outcomes

Urinary NTX and serum osteocalcin will be assessed at baseline, 3, 6, 9, and 12 months and when unexpected skeletal related events is detected.
time frame: one year

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. 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) 2. Men or women aged ≥ 18 years 3. WHO (ECOG) performance status 0-2 4. Women of child-bearing potential must be using a reliable and appropriate method of contraception 5. Urine sample taken and sent to the central laboratory for baseline Ntx analysis 6. Written informed consent. Exclusion Criteria: 1. Bisphosphonate treatment within the 4 weeks prior to planned first study treatment 2. Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute 3. Poor venous access 4. Metabolic bone disease 5. Unable to comply with study procedures, especially the reliable collection of urine samples for bone resorption marker measurements 6. Estimated life expectancy of < 6 months 7. Treatment with systemic bone seeking radioisotopes within the 3 months prior to study entry 8. Wide field (hemi-body) radiotherapy within the 3 months prior to study entry 9. Concomitant medication with drugs known to affect bone metabolism 10. Pregnancy or breast-feeding 11. 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) 12. Recent (within 4 weeks of study entry*) or planned dental or jaw surgery

Additional Information

Official title 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
Principal investigator Jae Bok Lee, MD.PhD
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 metastases progression - overall survival - the incidence of each adverse event including osteonecrosis
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Korean Breast Cancer Study Group.