JPRN-jRCT2080221578未知1 期
A Phase 1 study of Eribulin Mesylate with Trastuzumab for Advanced or Recurrent Human Epiderma Growth Factor Receptor 2-Positive (HER2+) Breast Cancer.
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 24
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 <= 74age old（—）
- 性别
- Female
入选标准
- •Females aged >-20 years and <75 years at the time of informed consent.
- •Histologically or cytologically confirmed with breast cancer.
- •Score 3+ by immunohistochemistry (IHC) or HER2 positive by FISH method.
- •Subjects who meet any of the followings
- •-Evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane
- •-Evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane
- •-Experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breat cancer
- •Adequate organ function.
- •Eastern Cooperative Oncology Group(ECOG) Performance Status (PS) is 0 or 1.
- •Subjects who have submitted written informed consent for study entry.
排除标准
- •Subjects with known brain metastasis accompanying clinical symptoms or requiring active treatment.
- •Subjects with severe active infection requiring active treatent.
- •Subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage.
- •Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives
- •Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV) by serum test.
- •Subjects who are pregnant (positive Beta-hCG test) or breastfeeding.
- •Subjects judged to be ineligible for this study by the principal invesigator or subinvestigator.
研究者
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