A randomised pragmatic open-label, multicentre, non-crossover clinical study to evaluate and compare the efficacy, safety profile and tolerability of oral ibandronate versus intravenous (iv) zoledronate in the treatment of breast cancer patients with bone metastases

Phase 3

Completed

• Conditions: Breast cancer with bone metastases; Cancer; Breast

• Registration Number: ISRCTN13914201
• Lead Sponsor: Velindre NHS Trust

Brief Summary

2013 sub-study results in: http://www.ncbi.nlm.nih.gov/pubmed/24107437

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-13
• Study Completion: 2008-09-30
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1400

Inclusion Criteria

1. Patients with newly diagnosed (<3 months) multiple bone metastases from histologically proven breast cancer and considered suitable for treatment with a bisphosphonate
2. Isotope bone scan within 6 weeks prior to screening to provide evidence of multiple bone metastases
3. Patients may also be receiving chemotherapy and/or hormone therapy for metastatic disease
4. Patients with multiple (>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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified