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NCT Number: NCT02553850

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

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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

  1. Beta C-terminal telopeptide (B-CTx) level

    Time frame: 12 months

  2. Treatment response rate

    Time frame: 12 months

Secondary outcomes

  1. Number of patients who died due to progression of breast cancer

    Time frame: 12 months

  2. Safety: Incidence of adverse events

    Time frame: 12 months

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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.

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