SLCTR/2012/003终止3 期
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
Boehringer Ingelheim India (Pvt) Ltd0 个研究点目标入组 790 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 790
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Histologically confirmed diagnosis of HER2-overexpression breast cancer 2. Stage IV metastatic disease 3. Must have progressed on one prior trastuzumab treatment 4. no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line) 5. Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer 6. Must have (archived) tumour tissue sample available for central re-assessment of HER2-status 7. At least one measurable lesion according to RECIST 1.1. 8. ECOG score of 0 or 1.
排除标准
- •1. Prior treatment with EGFR/HER2-targeted small molecules or antibodies other than trastuzumab 2. Prior treatment with vinorelbine 3. Known pre-existing interstitial lung disease 4. Active brain metastases 5. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization. 6. Cardiac left ventricular function with resting ejection fraction of less than 50%. 7. Patients unable to comply with the protocol. 8. Any contraindications for therapy with vinorelbine or trastuzumab. 9. Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs. 10. Use of any investigational drug within 4 weeks of randomization. 11. Inadequate hepatic, renal and haematologic organ function
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