An Observational Study in Patients With Breast Cancer and Bone Metastases Receiving Ibandronate (Bondronat)
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT02553850
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This open non-randomized, single-arm, multicenter, observational study is designed to evaluate the correlation between bone turnover markers and the response to treatment in patients with breast cancer and bone metastases. In this observational study, ibandronate (Bondronat) will be prescribed and used in accordance with the standards of care. Data will be collected for 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 442
Inclusion Criteria
- All criteria in accordance with the Summary of Product Characteristics of Bondronat (ibandronate)
- Adult patients greater than (>) 18 years of age
- Histologically confirmed breast cancer
- Confirmed bone metastasis (by bone scintigraphy, X-ray, computed tomography or magnetic resonance imaging)
- Life expectancy >6 months
- No previous bisphosphonate therapy
- Patients signed written informed consent form before study start
Read More
Exclusion Criteria
- All criteria in accordance with the Summary of Product Characteristics of Bondronat(ibandronate)
- Hypersensitivity to the active substance or any of the excipients of Bondronat (ibandronate)
- Hypersensitivity to bisphosphonates
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Beta C-terminal telopeptide (B-CTx) level 12 months Treatment response rate 12 months
- Secondary Outcome Measures
Name Time Method Number of patients who died due to progression of breast cancer 12 months Safety: Incidence of adverse events 12 months