An Observational Study in Patients With Breast Cancer and Bone Metastases Receiving Ibandronate (Bondronat)

Roche

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02553850

ML20416

Details and patient eligibility

About

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.

Enrollment: 442 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

442 participants in 1 patient group

Ibandronate

Description:

Patients receiving ibandronate will be evaluated for bone turnover markers for 12 months. Ibandronate is not an investigational medicinal product (IMP) in this study.