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

Hoffmann-La Roche442 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

442

Conditions

Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Unnamed facility

Budapest, Hungary

Unnamed facility

Budapest, Hungary

Unnamed facility

Budapest, Hungary

Outcomes

Primary Outcomes

Beta C-terminal telopeptide (B-CTx) level

Time frame: 12 months

Treatment response rate

Time frame: 12 months

Secondary Outcomes

Number of patients who died due to progression of breast cancer

Time frame: 12 months

Safety: Incidence of adverse events

Time frame: 12 months

Data from ClinicalTrials.gov

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