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
- 144
- 试验地点
- 1
- 主要终点
- Objective Response (ORR)
研究概览
简要总结
This study will assess the relationship between fulvestrant dose and efficacy in 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
- 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 (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 BC.
- •Treatment with more than one previous regimen of endocrine therapy for advanced BC.
- •An existing condition that prevents compliance.
研究组 & 干预措施
1
Fulvestrant 250 mg (intramuscular injection 250 mg)
干预措施: Fulvestrant (Drug)
2
Fulvestrant 250 mg (+ 250 mg loading regimen)
干预措施: Fulvestrant (Drug)
3
Fulvestrant 500 mg (intramuscular injection 500 mg)
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Objective Response (ORR)
时间窗: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).
次要结局
- Time to Progression (TTP)(The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.)
- Duration of Response (DoR)(The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.)
- Clinical Benefit Rate (CBR)(The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.)
- 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)