LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 508
- 试验地点
- 206
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) 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
- 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
Arm B: trastuzumab with vinorelbine
patients receive weekly intravenous infusion of trastuzumab and vinorelbine
干预措施: trastuzumab (Drug)
Arm B: trastuzumab with vinorelbine
patients receive weekly intravenous infusion of trastuzumab and vinorelbine
干预措施: vinorelbine (Drug)
Arm A: BIBW 2992 with vinorelbine
patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine
干预措施: BIBW 2992 (Drug)
Arm A: BIBW 2992 with vinorelbine
patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine
干预措施: vinorelbine (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months
PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered. Progression of disease was determined if at least 1 of the following criteria applied: * At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm * Appearance of 1 or more new lesions * Unequivocal progression of existing non-target lesions
次要结局
- Overall Survival (OS)(From randomisation (07Sep2010) to database lock (30Jul2018), up to 95 months.)
- Best RECIST Assessment(From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months)
- Objective Response (OR)(Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Until final data-base lock on 30 Jul 2018; Up to 95 months))