NCT02909361Unknown不适用
A Multicenter, Prospective, Real-world Study to Evaluate the Safety Profile and Effectiveness in Chinese Patients Who Received Fulvestrant 500mg as First-line Endocrine Treatment for Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0
研究概览
简要总结
Fulvestrant 500mg in Patients With Advanced Breast Cancer
详细描述
A multicenter, prospective study real-world to evaluate the safety profile and effectiveness in Chinese patients who received Fulvestrant 500mg as first-line endocrine treatment for Advanced breast cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer who has already received Fulvestant 500mg treatment as determined by treating physician. Ovarian suppression in premenopausal women is permitted, including ovarian ablation and LHRHa.
- •Histologically confirmed positive oestrogen receptor status (ER positive) of primary breast cancer or metastatic tumour tissue, according to the local laboratory parameters.
- •Prior endocrine therapy for advanced disease was not permitted.
- •The prescription of the Fulvestant is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Fulvestant injection.
- •Provision of subject informed consent.
排除标准
- •If participating in any controlled clinical trial, the subject cannot take part in this study.
- •HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
- •Pervious regimen of endocrine therapy for advanced disease.
- •More than one regimen of chemotherapy for advanced disease.
- •Pregnancy and lactation.
- •Severe hepatic impairment.
研究组 & 干预措施
Fulvestrant
500 mg on days 0, 14, and 28, and every 28 days thereafter
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0
时间窗: From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.
Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0
次要结局
- ORR(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
- CBR(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
- OS(From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.)
- PFS(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
研究者
Xichun Hu
Director of department of medical oncology
Fudan University
研究点 (1)
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