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临床试验/NCT01265654
NCT01265654已完成不适用

Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer

AstraZeneca1 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
234
试验地点
1
主要终点
Reasons for change of hormonal therapy (biochemical progression, objective progression, symptomatic progression, safety reasons, other)

研究概览

简要总结

Breast cancer is the leading type of cancer in women. Although big advance in diagnostics and treatment of early and breast cancer has been made in recent years breast cancer still has a significant mortality rate. A number of treatment modalities exist for postmenopausal women with advanced breast cancer. The treatment modality is chosen based on patient and tumour characteristics. Hormonal treatment is preferred and recommended in women with hormone sensitive breast cancer (ESMO, CECOG and NCCN guidelines). Tumor markers are an established method of monitoring systemic therapies in various cancers. Tumor markers CA 15-3 and CEA are used in clinical practice to monitor treatment efficacy of metastatic breast cancer. Blood levels of tumor markers are widely used to assess response/progression to treatment and guide therapy change. Treatment efficacy is assessed by imaging methods in clinical studies. Change of therapy in clinical study is usually done when progression based on RECIST criteria is found. Hormonal treatment has slower onset of effect compared with chemotherapy that can last several weeks. Also when a new therapy is started spurious early rises may occur. Therefore rising levels of tumor markers during the first weeks of new hormonal therapy are not necessarily sign of progression and should not be the only guidance for treatment change. Evidence of treatment efficacy form clinical studies and treatment change is based on imaging techniques.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women with at least two finished lines of hormonal treatment for advanced breast cancer Tumor markers (CEA. CA15-3) values available at the time of onset and discontinuation of therapy Imaging methods results available at the time of onset and discontinuation of therapy

排除标准

  • 未提供

结局指标

主要结局

Reasons for change of hormonal therapy (biochemical progression, objective progression, symptomatic progression, safety reasons, other)

时间窗: Every 3 months

次要结局

  • Time to progression(Every 3 months)
  • Type of hormonal treatment(Every 3 months.)
  • Changes in values of tumor markers (CEA, CA 15.3)(Every 3 months.)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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