A Perspective Study of the Predictive Value of microRNA in Patients With HER2 Positive Advanced Stage Breast Cancer Who Were Treated With Herceptin
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- overall survival of patients
研究概览
简要总结
This projective observational study is planned to enroll more than 300 advanced breast cancer patients, who were proved as Her-2 positive using fluorescence in situ hybridization (FISH) and / or immunohistochemistry, and 100 healthy donors as control. Before treatment, the plasma microRNA will be collected and detected by microRNA extraction kit and quantitative polymerase chain reaction (qPCR), respectively. After analyzed their microRNA expression by microRNA predictive model, previously reported by our team, all of enrolled patients will be classified as "probable sensitive group" or "probable resistant group". Herceptin combined with other chemotherapy will be the backbone of salvage treatment and used for at least 3 months; the change of local masses and metastasis lesions after treatment will be documented to evaluate the response. Based on these results, investigator aim to construct a mathematical predictive model by analyzing the correlation of baseline microRNA expression level and the prognosis of patients. And a diagnosis microRNA kit will be planned and manufactured
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The patients signed the written informed consent
- •female patient who is ≥ 18yrs,
- •HER2 positive: immunohistochemistry (+++) or FISH (+)
- •the patients have no history of chemotherapy ,hormone therapy,radiotherapy or surgery after diagnosis of breast cancer
- •the result of patients' blood tests are as follow: WBC≥3.0×109/L; Plt≥100×109/L;AST/SGOT or ALT/AGPT≤tripple of normal upper limit; Creatinine<double of the normal upper limit
- •ECOG scores are 0 or 1 .
- •The patient is able to take oral pills
排除标准
- •The patient was never exposed to herceptin.
- •The patient suffered from other non-breast malignancy in the last 5 years, except for cervical carcinoma in situ, radical basal cell carcinoma or squamous cell carcinoma.
- •The life expectancy is less than 3 months.
- •Severe hepatic function disorder, Child Pugh grade C.
- •Severe cardiac function disorder, cardiac function is more than grade III;
- •Prolonged QT interval;
- •Arrhythmia or taking anti-arrhythmia drugs;
- •Pregnant or breast feeding female.
研究组 & 干预措施
Herceptin probable sensitive group
Plasma microRNAs will be collected using microRNA extraction kit according to manufacturer's instructions; and their expression levels are analyzed by quantitative polymerase chain reaction (qPCR).According to microRNAs - herceptin predictive model(reported by our team), the patients will be considered as Herceptin probable sensitive group
干预措施: Capecitabine (Drug)
Herceptin probable sensitive group
Plasma microRNAs will be collected using microRNA extraction kit according to manufacturer's instructions; and their expression levels are analyzed by quantitative polymerase chain reaction (qPCR).According to microRNAs - herceptin predictive model(reported by our team), the patients will be considered as Herceptin probable sensitive group
干预措施: Trastuzumab (Drug)
Herceptin probable resistant group
Plasma microRNAs will be collected using microRNA extraction kit according to manufacturer's instructions; and their expression levels are analyzed by quantitative polymerase chain reaction (qPCR).According to microRNAs - herceptin predictive model(reported by our team), the patients will be considered as Herceptin probable resistant group
干预措施: Capecitabine (Drug)
Herceptin probable resistant group
Plasma microRNAs will be collected using microRNA extraction kit according to manufacturer's instructions; and their expression levels are analyzed by quantitative polymerase chain reaction (qPCR).According to microRNAs - herceptin predictive model(reported by our team), the patients will be considered as Herceptin probable resistant group
干预措施: Trastuzumab (Drug)
结局指标
主要结局
overall survival of patients
时间窗: Overall survival was defined as the interval from the diagnosis of advanced breast cancer with HER2 positive to death due to any causes or last follow-up,The follow-up interval is 2 years.
Progress-free survival of patients
时间窗: progression free survival (PFS) was defined as the interval from the diagnosis of advanced breast cancer with HER2 positive to disease progression, relapse, death due to any causes or last follow-up.The follow-up interval is 2 years.
次要结局
未报告次要终点
研究者
Erwei Song, M.D., Ph.D.
President of Sun Yat-Sen Memorial Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University