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

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553850
• Other study ID #: ML20416
• Status: Completed
• Phase: N/A
• First received: September 8, 2015
• Last updated: October 29, 2016
• Start date: April 2007
• Est. completion date: January 2010

Study information

• Verified date: October 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta C-terminal telopeptide (B-CTx) level		12 months	No
Primary	Treatment response rate		12 months	No
Secondary	Number of patients who died due to progression of breast cancer		12 months	No
Secondary	Safety: Incidence of adverse events		12 months	No