NCT01975142已完成2 期
Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 10
- 主要终点
- Tumor response rate to T-DM1 in patients with HER2 amplified circulating tumor cells
研究概览
简要总结
Patients with metastatic breast cancer considered HER2 negative are screened for HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II with an adaptive design.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for screening:
- •Breast adenocarcinoma considered HER2-negative on the primary tumour or unknown status HER2
- •A least one metastatic site and/or inoperable loco-regional relapse
- •Measurable disease (RECIST v1.1)
- •Age from 18 to 75 years
- •Performance status of 0-2
- •Efficient contraceptive in non-menopause women
- •Inclusion criteria for treatment :
- •At least 1 (Cohort " L ") or 3 (cohort " H ") HER2 amplified CTC
- •Performance status of 0-2
- •Adequate cardiac function
- •Adequate hematological and biochemical blood tests
排除标准
- •Life expectancy of less than 3 months
- •Previous history of any other stage III or IV invasive cancer
- •Male breast cancer
- •Uncontrolled brain metastases
- •Significant cumulated exposure to anthracyclines
- •Current or previous significant history of cardio-vascular/pulmonary disease
- •Previous use of trastuzumab
研究组 & 干预措施
TDM-1
Experimental
干预措施: Trastuzumab - Emtansine (Drug)
结局指标
主要结局
Tumor response rate to T-DM1 in patients with HER2 amplified circulating tumor cells
时间窗: Until disease progression (estimated duration : 1 year)
Assessment every 6 weeks.
次要结局
- Circulating tumor DNA before and during treatment(Until disease progression (estimated duration : 1 year))
- Detection rate of HER2 amplified circulating tumor cells, heterogeneity rate between circulating tumor cells and correlations with patient characteristics(1 month)
- Disease control rate (responses and stable diseases)(Until disease progression (estimated duration : 1 year))
- Correlation between treatment efficacy and HER2 FISH results (level of amplification, absolute number and percentage of amplified cells)(Until disease progression (estimated duration : 1 year))
- Correlation between HER2 FISH and immunofluorescence on circulating tumor cells(1 month)
- Progression-free survival(4 years)
- Technical failure rate and reproducibility of HER2 FISH on circulating tumor cells(1 month)
- Treatment toxicity(Until disease progression (estimated duration : 1 year))
- Changes in CTC numbers during treatment(Until disease progression (estimated duration : 1 year))
研究者
研究点 (10)
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