ADRIAMYCIN PLUS ZINECARD V NO TREATMENT IN ADVANCED BREAST CA AFTER 6 CYCLES CAF

ADRIAMYCIN PLUS ZINECARD V 在 6 个周期 CAF 后未在高级乳腺癌 CA 中进行治疗

• 批准号: 6246869
• 负责人: JAMES SPEYER
• 金额: $ 2.39万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-12 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6246869
• 关键词: breast neoplasms; cardiovascular agents; chemoprevention; clinical research; congestive heart failure; cyclophosphamide; doxorubicin; drug screening /evaluation; human subject; human therapy evaluation

The primary objectives of this randomized Phase IIIb two armed trial are to 1) evaluate whether continuing therapy with Adriamycin and dexrazoxane (which is cardioprotective) prolongs time to progression in patients with locally advanced or metastatic breast cancer who are stable or in response after receiving six courses of front-line CAF chemotherapy compared to similar patients whose chemotherapy has been interrupted after 6 courses of chemotherapy; 2) whether continuing therapy with these agents prolongs time to disease progression, development of CHF, or death compared to patients who had chemotherapy interrrupted; 3) to evaluate the effect on performance status, tumor-related symptoms and safety of both agents.

这项随机 IIIb 期两组试验的主要目标是 1) 评估是否继续使用阿霉素和右雷佐生治疗 （具有心脏保护作用）延长患有以下疾病的患者的进展时间 病情稳定或有反应的局部晚期或转移性乳腺癌 接受六个疗程的一线 CAF 化疗后与 6个疗程后化疗中断的类似患者 化疗； 2）继续使用这些药物治疗是否会延长时间 与其他疾病相比，疾病进展、CHF 发生或死亡的时间 化疗中断的患者； 3）评估效果 两种药物的性能状态、肿瘤相关症状和安全性。