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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Budapest, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A SURVEY TO STUDY THE CORRELATION BETWEEN THE SERUM LEVELS OF BONE TURNOVER MARKERS AND THE CLINICAL PICTURE IN PATIENTS WITH BREAST CANCER AND BONE METASTASES RECEIVING IBRADONIC ACID TREATMENT

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Sep 18, 2015
Registry last updated: Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed