Using PERS(PErsonalized Regimen Selection) Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer Multicentric, Prospective, Randomized Controlled Phase III Clinical Study

Shi Yanxia1 个研究点分布在 1 个国家目标入组 320 人开始时间: 2016年4月最近更新: 2017年1月16日

适应症

干预措施

试验速览

阶段: 3 期
发起方
入组人数: 320
试验地点: 1
主要终点: Surgical specimens of breast primary tumors and axillary lymph nodes as measured by Pathological examination.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study aims to explore new PERS prediction model can improve the pathological complete response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival.

详细描述

This is a multi-center, prospective, randomized phase III clinical trial. Planning 320 cases.

This study will be divided into two stages. Phase one, 120 cases of local advanced breast cancer (LABC)who need neoadjuvant chemotherapy. Gene prediction model test(PERS) is performed before treatment(ddEC-T+/-H), verify the prediction efficacy of PERS.

Phase two, 200 cases of LABC primary resistant of antharcycline and taxans. Patients were randomized to Arm ddEC-T+/-H and Arm PERS (regimens according to PERS,eg NVB+DDP,capacitabine,gemcitabine and so on) pCR rate and DFS is observed.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

未提供

排除标准

•ECOG(Eastern Cooperative Oncology Group) scoring ≥2 ;
•At the same time to accept any other anti-tumor treatment.
•In the past 12 months have congestive heart failure, drug treatment can't control history of arrhythmia, myocardial infarction, etc;
•The serious, which has not been controlled intercurrent infection, organ dysfunction, or serious metabolic disorder of patients;
•Active infection (decided by the researchers.
•According to the researcher's judgment, there is serious to endanger the safety of patients, or patients completed the research associated with disease.
•Pregnancy or breast-feeding women.
•Always have a clear history of neurological or psychiatric disorders, including epilepsy, or dementia.
•A history of other tumors or combined with other tumor patients.
•Before study enrollment for any reason within 30 days of use had not been approved by the local drug ；
•Unwilling or unable to continue to comply with the experimental program, or can not cope with patients follow-up;
•Researchers think that is unfavorable to the participants.