A prospective, randomized, multi-center comparative 2-arm trial on efficacy and safety of zoledronic acid every 3-months vs. every 4 weeks beyond approximately 1 year of treatment with zoledronic acid in patients with bone lesions from breast cancer - ND

• Conditions: bone metastasis in patients with breast cancer; MedDRA version: 6.1Level: PTClassification code 10027452

• Registration Number: EUCTR2005-004942-15-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 420

Inclusion Criteria

Female patients 18 years of age. Written informed consent given. Histologically confirmed Stage IV breast cancer with at least one bone metastasis radiologically confirmed. Life expectancy 1 year. Treatment with Zometa every 3-4 weeks, for 9-12 infusions over no more than 15 months. ECOG performance status 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

More than 3 months since last infusion of Zometa. Treatments with other bisphosponates than Zometa at any time prior to study entry. Serum creatinine 3 mg/dL 265 mol/L or calculated Cockcroft-Gault formula creatinine clearance CLCr 30 mL/min CrCl 140-age years x weight kg x 0.85 72 x serum creatinine mg/dL Corrected adjusted for serum albumin serum calcium 8 mg/dl 2 mmol/L or 12 mg/dL 3.0 mmol/L . Current active dental problem including infection of the teeth or jawbone maxilla or mandibular ; dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw ONJ , of exposed bone in the mouth, or of slow healing after dental procedures. Recent within 6 weeks or planned dental or jaw surgery e.g. extraction, implants . Pregnant patients with a positive pregnancy test prior to study entry or lactating patients. Women of childbearing potential not using effective methods of birth control e.g. abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide . History of non-compliance to medical regimens or potential unreliable behavior. Known sensitivity to study drug s or class of study drug s . Patients with severe medical condition s that in the view of the investigator prohibits participation in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified