NCT01492101已完成3 期
The BEACON Study (Breast Cancer Outcomes With NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane and Capecitabine
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 852
- 试验地点
- 152
- 主要终点
- Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population
研究概览
简要总结
The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.
The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NKTR-102
Experimental
干预措施: NKTR-102 (Drug)
Physician's Treatment of Choice
Active Comparator
干预措施: Treatment of Physician's Choice (TPC) (Drug)
结局指标
主要结局
Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population
时间窗: 36 Months
Duration of OS was defined as the time from the date of randomisation to the date of death due to any cause. Subjects were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. OS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. Subjects who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Subjects who did not have any follow-up since the date of randomization were censored at the date of randomization.
次要结局
- Kaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population(Up to 38 months.)
- Clinical Benefit Rate (CBR): ITT Population(Up to 38 months.)
- Duration of Response (DOR): Efficacy Evaluable Population(Up to 38 months.)
- Incidence of Dose Reductions: Safety Population(Up to 38 months.)
- Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population(Up to 39 months)
- QLQ-C30 Individual Scale, Change Over Time: ITT Population(From Baseline to Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56.)
- Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population(Baseline)
- BR23 Score Change Over Time: ITT Population(Up to 38 months.)
- Objective Response Rate (ORR): Efficacy Evaluable Population(Up to 38 months.)
- Population Mean ± Standard Deviation (SD) Area Under the Concentration-Time Curve (AUC) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [25](Up to 38 months.)
- Population Mean ± SD Maximum Plasma Concentration (Cmax) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [26](Up to 38 months.)
- Population Mean ± SD Elimination Half-life (t½) for NKTR-102 After Multiple Administration of 145 mg/m^2 NKTR-102 [27](Up to 38 months.)
研究者
研究点 (152)
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3 期
The BEACON Study (BrEAst Cancer Outcomes with NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician*s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane, and CapecitabineMetastatic Breast CancerNL-OMON41606ektar Therapeutics10