A phase II, double blind, randomised, dose ranging, safety and efficacy trial of rapid intravenous infusion of Zoledronate versus Aredia in breast cancer patients with osteolytic metastases

Cancer Research UK (CRUK) (UK)0 个研究点目标入组 0 人开始时间: 2002年8月19日最近更新: 2020年1月6日

适应症

试验速览

暂无简介。

•1. Aged >18 years
•2. Histologically confirmed diagnosis of breast cancer
•3. At least one osteolytic lesion which measures at least 1 cm in diameter which has not been treated with radiation therapy in the 3 months prior to the start of treatment
•4. Metastatic bone lesions confirmed by plain films
•5. Life expectancy of at least 10 months
•6. Performance status (Eastern Cooperative Oncology Group [ECOG]) of 1-2
•7. Satisfactory haematological and blood chemistry values
•8. No previous continuous treatment (> four doses) with a bisphosphate, or treatment with a bisphosphate within 3 months of the start of treatment. Treatment with another bisphosphate is not allowed at any time during the trial.
•9. Patients for whom orthopaedic surgery to bone or radiation therapy to bone is currently scheduled to treat skeletal disease related to metastatic bone lesions may not enter the trial. A previous history of such procedures is permitted only if the procedure was completed more than 2 weeks prior to the start of treatment
•10. Patients who develop hypercalcaemia may be treated with a standard therapy other than a bisphosphate and remain on the trial
•11. No recent treatment with cacitonin, mitharmycin or gallium nitrate
•12. No previous history of allergic reactions or sensitivity to bisphosphates
•13. Normal electrocardiogram (ECG)

发起方

Cancer Research UK (CRUK) (UK)