Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.
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
- 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
排除标准
- •Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer
- •Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
- •An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
研究组 & 干预措施
1
Fulvestrant 250 mg intramuscular injection
干预措施: Fulvestrant (Drug)
2
Fulvestrant 250mg (Plus 250mg Loading Regimen)
干预措施: Fulvestrant (Drug)
3
Fulvestrant 500 mg
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)
An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response. Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization
次要结局
- Time to Progression (TTP)(every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008))
- Duration of Response (DoR)(RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.)
- Clinical Benefit Rate (CBR)(every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.)
- Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body(Baseline to 12 weeks)
- Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes(Baseline to 12 weeks)