Breast cancer Cancer Breast cancer
Conditions
Interventions
All patients receive treatment for 9 months.
Patients are randomised to one of four treatment groups:
1. Group A: Zoledronate 0.4 mg in 50 ml normal saline rapid infus
Sponsors
Cancer Research UK (CRUK) (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged >18 years 2. Histologically confirmed diagnosis of breast cancer 3. At least one osteolytic lesion which measures at least 1 cm in diameter which has not been treated with radiation therapy in the 3 months prior to the start of treatment 4. Metastatic bone lesions confirmed by plain films 5. Life expectancy of at least 10 months 6. Performance status (Eastern Cooperative Oncology Group [ECOG]) of 1-2 7. Satisfactory haematological and blood chemistry values 8. No previous continuous treatment (> four doses) with a bisphosphate, or treatment with a bisphosphate within 3 months of the start of treatment. Treatment with another bisphosphate is not allowed at any time during the trial. 9. Patients for whom orthopaedic surgery to bone or radiation therapy to bone is currently scheduled to treat skeletal disease related to metastatic bone lesions may not enter the trial. A previous history of such procedures is permitted only if the procedure was completed more than 2 weeks prior to the start of treatment 10. Patients who develop hypercalcaemia may be treated with a standard therapy other than a bisphosphate and remain on the trial 11. No recent treatment with cacitonin, mitharmycin or gallium nitrate 12. No previous history of allergic reactions or sensitivity to bisphosphates 13. Normal electrocardiogram (ECG)
Exclusion criteria
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed