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临床试验/NCT03359694
NCT03359694Unknown3 期

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

Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年12月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Active Comparator

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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