Breast cancer with bone metastases Cancer Breast
Conditions
Interventions
Comparison of skeletal related events in patients on iv zoledronate given 3-4 weekly and oral daily ibandronate.
Blood samples analysed 3-4 weekly
lumbar and thoracic plain spine X-rays at baseline and end of treatment. Analysis of quality of life (QoL), analgesic usage and pain scoring.
Sponsors
Velindre NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed (1) bone metastases (painful or asymptomatic) of lytic, mixed or purely sclerotic type 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
Exclusion criteria
Exclusion criteria: 1. Patients with a creatinine clearance of less than 30 ml/minute 2. Patients with serum bilirubin/aspartate transaminase (AST) (alanine transaminase [ALT]) raised more than 1.5 times normal 3. Patients with central nervous system (CNS) metastases 4. Patients who have undergone dental procedures in the 2 months prior to randomisation 5. Patients with known active peptic ulcer 6. Patients with hypocalcaemia within 6 weeks of randomisation 7. Patients who have received bisphosphonate therapy in the previous 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean number of skeletal related events (SREs) per patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first SRE; Andersen-Gill Multiple-event analysis; Percentage of patients with any SRE; Pain/analgesic scores; Safety (including survival); Quality of Life (QoL); Cost efficiency analysis. | — |
Countries
United Kingdom
Outcome results
None listed