JPRN-jRCT2080221730未知1 期
Phase 1b study of U3-1287 in combination with trastuzumab plus paclitaxel in patients with HER2-positive metastatic breast cancer (MBC)
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 36 人开始时间: 2012年3月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
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
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- Female
入选标准
- •Histologically or cytologically confirmed invasive carcinoma of the breast with metastatic disease
- •- Documented HER2-positive disease
- •- ECOG performance status: 0 or 1
排除标准
- •- Has history of anti-HER3 therapy
- •- Total dose of anthracyclines >= 360mg/m2 in prior treatment
- •- Patients with active other malignancies
- •- Has history or complication of interstitial lung disease by radiographic examination
- •- Left ventricular ejection fraction(LVEF) < 55% at enrollment or history of LVEF decline >= 10% from base line on prior trastuzumab therapy and the decline to <55%
- •- Has brain metastasis with clinical symptoms or requiring treatment
- •- Has history of serious drug hypersensitivity reaction such as anaphylaxis
研究者
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