NCT01340430已完成2 期
Neoadjuvant Therapy With FEC Followed by Weekly Paclitaxel and Concurrent Trastuzumab in Her2 Positive Non Operable Breast Cancer. Phase II Study.
Lucia Del Mastro,MD6 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 6
- 主要终点
- pathologic complete response
研究概览
简要总结
The main purpose of this study is to confirm the high pathologic complete response rate after neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent trastuzumab in Human Epidermal growth factor receptor2 (HER2) positive non operable breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male gender
- •Pregnant or lactating women
- •Received any prior treatment for primary invasive breast cancer
- •Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (> 180/110), unstable diabetes mellitus, dyspnoea at rest or chronic therapy with oxygen;
- •Active or uncontrolled infection,
- •Dementia altered mental status or any psychiatric condition that would prevent the under standing or rendering of informed consent,
- •Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies),
- •Previous or concomitant malignancy within the past 3 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
- •Concurrent disease or condition that would have make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
研究组 & 干预措施
FEC-paclitaxel-trastuzumab
Experimental
fluorouracil 600 mg/m2; epirubicin 90 mg/m2; cyclophosphamide 600 mg/m2 for 4 cycles followed by paclitaxel 80 mg/m2/week in combination with trastuzumab for 12 weeks
干预措施: Trastuzumab (Drug)
结局指标
主要结局
pathologic complete response
时间窗: at definitive surgery within 4 weeks after the last dose of paclitaxel and concurrent trastuzumab
次要结局
- safety and tolerability(one year)
- overall survival(one year)
- rate of conversion from radical to conservative surgery(definitive surgery)
- disease free survival(one year)
- cardiotoxicity(one year)
- potential biomarkers of trastuzumab resistance(one year)
研究者
Lucia Del Mastro,MD
md
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
研究点 (6)
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