ASSESSMENT OF BIOCHEMICAL MARKERS OF BONE TURNOVER IN PATIENTS WITH METASTATIC BREAST CANCER SWITCHED FROM INTRAVENOUS ZOLEDRONIC ACID THERAPY TO ORAL IBANDRONATE

niv. Prof. Dr. Christoph Zielinski0 个研究点目标入组 30 人开始时间: 2005年10月24日最近更新: 2016年11月7日

适应症

试验速览

暂无简介。

•-Signed informed consent
•-Female patients >18 years of age with histologically confirmed breast cancer with at least one osteolytic or mixed bone lesion confirmed by X-ray, CT scan or MRI (confirmation within 6 months before screening)
•-WHO performance status 0, 1 or 2 at screening
•-Life expectancy > 6 months
•-Patients must had at least 2 cycles of Zoledronic acid therapy before sreeening
•-the last dose of Zoledronic acid has to be given >3 weeks prior to start of Ibandronate therapy
•-Adequate hematology, hepatic and renal function ( < 3.0mg/dL or < 266µmol/L)
•-Stable antineoplastic therapy (including corticosteroids) for a least 4 weeks prior to screening
•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

•-History of brain metastases
•-Bone surgery within 5 weeks of sreening
•-High dose chemotherapy (>3x normal intensity) within 6 months
•-Uncontrolled calcemia (albumin corrected > 2.7mmol/L and < 2.0mmol/L)
•-Paget’s disease, untreated esophagitis or gastric ulcers
•-Known hypersensitivity to Ibandronate
•-Women lactating, pregnant, of childbearing potential or less than one year after menopause (unless surgically sterile) not using a reliable contraceptive method: intrauterine device, mechanical contraception (condom, diaphragm), oral, injectable or implanted contraceptives or total abstinence. Women of childbearing potential must have a negative pregnancy test at screening

发起方

niv. Prof. Dr. Christoph Zielinski