bone metastases in breast cancer
Conditions
Interventions
Group A:zoledronic acid 4mg Q3-5weeks
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Men or women aged >= 18 years; 2. Histological or cytological confirmed breast cancer; 3. 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); 4. Expected survival >= 6 months; 5. WHO (ECOG) performance status 0-2; 6. complete blood count (WBC >3.5*10^9/L, Neutrophile >1.5*10^9/L, Platelet >100*10^9/L, Hb >90 g/L); 7. Serum creatinine <1.5 times the upper limit of normal; 8. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Women in pregnancy or breast-feeding; 2. Metabolic bone disease; 3. Associated with brain metastases (except for no symptoms or has been controlled); 4. Received operation in 4 weeks before recruitment, except for the biopsy of lymph nodes; 5. Had used or were currently using other biphosphonate; 6. serum calcium level 5 times the upper limit of normal); 8. Current active dental problems including infection of the teeth or jawbone (maxilla or mandible), or a current or prior diagnosis of osteonecrosis of the jaw (ONJ); 9. Recent (within 6 weeks of study entry) or planned dental or jaw surgery; 10. Known allergy to any study medication; 11. patients with severe disease, may affect the assessment of research; 12. Unable to comply with study procedures; 13. Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skeletal-related events;N-telopeptide of type I collage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progress;Ache VAS appraisal; | — |
Countries
China
Contacts
Public ContactHong Zheng
Outcome results
None listed