Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 17
- 主要终点
- Objective Response (OR)
研究概览
简要总结
An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be obtained on the safety profile and pharmacokinetics of BIBW 2992.
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
BIBW 2992
BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
干预措施: BIBW 2992 (Drug)
Lapatinib
Lapatinib tablets 1500 mg daily.
干预措施: lapatinib (Drug)
Trastuzumab
Trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly.
干预措施: trastuzumab (Drug)
结局指标
主要结局
Objective Response (OR)
时间窗: Tumour assessments were performed at screening, day 22 and day 43.
Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.
次要结局
- Number of Participants Who Achieved Clinical Benefit (CB)(Tumour assessments were performed at screening, day 22 and day 43.)
- Plasma Concentration of Afatinib(Day 7)
- Changes in Biomarker in Tumour Biopsies(Screening, day 22, day 43)
- Change From Baseline in the Diameter of the Primary Target Lesion.(3 weeks or 6 weeks)