Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00381368
• Other study ID #: ML20115
• Secondary ID: EudraCT: 2006-00
• Status: Recruiting
• Phase: Phase 2
• First received: September 25, 2006
• Last updated: December 1, 2006
• Start date: October 2006

Study information

• Verified date: November 2006
• Source: University of Turku
• Contact: Outi Paija, MD, PhD
• Phone: +358-2-3130000
• Email: outi.paija[@]tyks.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skeletal metastases.

Description:

Painful skeletal metastases are a common site of advanced disease. For instance, in breast cancer, and despite cancer treatments (radiotherapy, cytotoxic treatment and adequate treatment of pain), the patients often need additional treatments that may relieve their symptoms. Bisphosphonates, such as ibandronic acid, have in pilot studies shown a significant decrease in pain scores, both after loading dose and after long-term treatment. In this study the safety and efficacy of an intravenous loading dose of three times 6 mg ibandronate during three consecutive days in breast cancer patients with painful skeletal metastases will be studied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Breast cancer with presence of bone metastases

• Pain score over 4 on the VAS

Exclusion Criteria:

• Patients with pathological fractures or medulla compression or neuropathic pain

• Patients with infection or corticosteroid treatment

• Pregnant or lactating patients

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Ibandronic acid

Locations

Country	Name	City	State
Finland	Dept of Oncology, Helsinki University Central Hospital	Helsinki
Finland	Dept of Oncology, Oulu University Hospital	Oulu
Finland	Dept of Oncology, Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
University of Turku	Hoffmann-La Roche

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worst and average pain in movement and rest on the visual analogue scale (VAS) before the first dose, on days 2, 3, 7 and on day 28
Primary	Analgesic consumption during the same period will additionally be assessed
Secondary	Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28
Secondary	World Health Organization (WHO) performance status
Secondary	Safety: serum cystatin C and serum creatinine, and reporting of adverse events