NCT00099437进行中（未招募）3 期
A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 736
- 试验地点
- 107
- 主要终点
- Time to Progression (TTP)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 130 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
- •Requiring hormonal treatment
- •Postmenopausal women defined as a woman who has stopped having menstrual periods
- •Evidence of positive estrogen receptor hormone sensitivity
- •Written informed consent to participate in the trial
排除标准
- •Treatment with an investigational or non-approved drug within one month
- •An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
- •A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil)
- •Treatment with more than one regimen of chemotherapy for advanced breast cancer
- •Treatment with more than one regimen of hormonal treatment for advanced breast cancer
研究组 & 干预措施
2
Experimental
Fulvestrant 250 mg
干预措施: Fulvestrant (Drug)
1
Experimental
Fulvestrant 500 mg
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Time to Progression (TTP)
时间窗: RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
次要结局
- Duration of Response (DoR)(RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months))
- Clinical Benefit Rate (CBR)(Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months))
- Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study(TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months))
- Overall Survival (OS) - Follow-up(Median time (in months) from randomisation until death (from any cause),up to 80 months)
- Overall Survival (OS)(Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months))
- Objective Response Rate (ORR)(RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months))
- Duration of Clinical Benefit (DoCB)(RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months))
研究者
研究点 (107)
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