JPRN-UMIN000007180已完成2 期
A phase II neoadjuvant trial of sequential tri-weekly nanoparticle albumin-bound paclitaxel (Abraxane)/cyclophosphamide, with trastuzumab in HER2-positive patients, followed by 5-fluorouracil/epirubicine/cyclophosphamide (FEC) in operable breast cancer - TRI-ABC FEC trial
Dept of surgical oncology, Hiroshima university hospital0 个研究点目标入组 54 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
研究概览
简要总结
The treatment outcomes and safety were evaluated in 54 patients who received at least 1 dose of chemotherapy. The overall pCR rate of 37% was achieved. The pCR rates according to each subtype were 8% in hormone receptor (HR)-positive HER2-negative breast cancer, 56% in HR-positive HER2-positive breast cancer, 63% in HR-negative HER2-positive breast cancer, and 62% in triple-negative breast cancer. Clinical response was observed in 49 patients (91%). The safety profile was acceptable.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 70years-old(—)
- 性别
- Female
入选标准
- 未提供
排除标准
- •Known hypersensitivity to any of study drugs History of receiving any endocrine therapy or chemotherapy for breast cancer within 5 years prior to registration Concurrent, other malignancies Concurrent bilateral breast cancer (except for contra-lateral non-invasive or lobular breast cancer) Male Concurrent, serious or uncontrolled infections Inadequately controlled or serious history of cardiac disease Inadequately controlled diabetes mellitus Concurrent, gastrointestinal ulceration or bleeding Current pregnancy and lactation, or possibility of pregnancy Assessment by investigator that subject unable to comply with protocol
研究者
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