Mutation Scores and Differential Protein Evaluating Efficacy in Neo-adjuvant Chemotherapy and the Non-PCR Patients Treated With Sequential Nalvelbine and Xeloda in HER2(-) Luminal B Breast Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- pCR rate
研究概览
简要总结
We plan to carry out a prospective, randomized, open phase III clinical trial which sponsored by the Tianjin Medical University Cancer Hospital and Institute. The primary aim is to evaluate pCR of DT and ET regimen as neoadjuvant chemotherapy in the treatment of HER2 negative Luminal B breast cancers and the correlation of pCR respectively with the susceptible gene mutation scores and differential protein identified by proteomics. For patients with pCR, the association between the 5 year DFS and susceptible gene mutation scores and differential protein identified by proteomics will be evaluated. All Non-pCR patients will receive NX chemotherapy for 4 cycles, and to evaluate correlations between 5 year DFS of these patients respectively with susceptible gene mutation scores and differential protein identified by proteomics, and to evaluate the safety of neoadjuvant chemotherapy and sequential adjuvant NX regimen therapy. Meanwhile, we will verify susceptible gene mutation scores and differential protein identified by proteomics are significant predictors of HER2 negative Luminal B breast cancer chemotherapy sensitivity and prognosis, and explore the feasibility of susceptible gene mutation scores and differential protein in clinical application.
详细描述
This is a prospective, randomized, open phase III clinical trial which will be sponsored by the Tianjin Medical University Cancer Hospital and Institute. The primary aim is to evaluate pCR of Pegylated Liposomal Doxorubicin and Docetaxel (DT) Compared to Conventional Doxorubicin and Docetaxel (ET) regimen as neoadjuvant chemotherapy in the treatment of HER2 negative Luminal B breast cancers and the correlation of pCR respectively with the susceptible gene mutation scores and differential protein identified by proteomics. For patients with pCR, the association between the 5 year DFS and susceptible gene mutation scores and differential protein identified by proteomics will be evaluated. All Non-pCR patients will receive NX chemotherapy for 4 cycles, and to evaluate correlations between 5 year DFS of these patients respectively with susceptible gene mutation scores and differential protein identified by proteomics, and to evaluate the safety of neoadjuvant chemotherapy and sequential adjuvant Nalvelbine and Xeloda (NX) regimen therapy. Meanwhile, we will verify susceptible gene mutation scores and differential protein identified by proteomics are significant predictors of HER2 negative Luminal B breast cancer chemotherapy sensitivity and prognosis, and explore the feasibility of susceptible gene mutation scores and differential protein in clinical application.
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
- Double (Participant, Investigator)
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
- 否
入选标准
- •Signed informed consent form
- •Compliance with test procedures and good compliance
- •Females, Age more than 18 years of age, less than 70 years old
- •The ECOG score is 0-1
- •Primary invasive cancer, T2-4bN0-2M0 breast cancers
- •Neoadjuvant chemotherapy with standard 6 courses should be completed
- •Patients must undergo standard breast cancer surgery after neoadjuvant chemotherapy
- •Luminal B, Her2 negative patients
- •No other malignant tumors occurred at the same time
- •adequate liver and kidney function
排除标准
- •Any metastasis
- •Suffered other maligant tumors
- •Participate in other trials
- •Accompanied with severe systemic disease and / or uncontrollable infection
- •Pregnant and lactating women
- •Dysfunction of liver and kidney
研究组 & 干预措施
DT group
Pegylated liposomal doxorubicin and Docetaxel Treatment group Pegylated liposomal doxorubicin 30mg/m2,iv,d1, Docetaxel 75mg/m2,iv,d1, q21d×6
干预措施: DT group (Drug)
ET group
Conventional doxorubicin and Docetaxel Treatment group Conventional doxorubicin 75mg/m2,iv,d1, Docetaxel 75mg/m2,iv,d1, q21d×6
干预措施: ET group (Drug)
NX group
Navelbine and Xeloda treatment group in group of Non-pCR patients Navelbine IVD 25 mg/m2 D1、D8 Xeloda PO 1000 mg/m2 bid D1-D14 q21d×4
干预措施: NX group (Drug)
结局指标
主要结局
pCR rate
时间窗: 2 years
pCR rate in the DT and ET group
次要结局
- Efficacy of neo-adjuvant chemotherapy(5 years)
- Efficacy of sequential chemotherapy(6 years)
