EUCTR2005-004942-15-IT进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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