Clinical Trials /

Mutation Scores and Differential Protein Evaluating Efficacy in Adjuvant Chemotherapy in HER2(-) Luminal B Breast Cancer

NCT03359694

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03359694

Trial Eligibility

Document

Title

  • Brief Title: Mutation Scores and Differential Protein Evaluating Efficacy in Adjuvant Chemotherapy in HER2(-) Luminal B Breast Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: NO20170819
  • NCT ID: NCT03359694

Conditions

  • Susceptibility, Genetic
  • Chemotherapy Effect

Interventions

DrugSynonymsArms
DT groupPegylated liposomal doxorubicin and DocetaxelDT group
ET groupConventional doxorubicin and DocetaxelET group
NX groupNavelbine and XelodaNX group

Purpose

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.

Detailed Description

      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.

Trial Arms

NameTypeDescriptionInterventions
DT groupExperimentalPegylated liposomal doxorubicin and Docetaxel Treatment group Pegylated liposomal doxorubicin 30mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6
  • DT group
ET groupActive ComparatorConventional doxorubicin and Docetaxel Treatment group Conventional doxorubicin 75mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6
  • ET group
NX groupExperimentalNavelbine 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
  • NX group
Control groupNo Interventionno treatment group of Non-pCR patients after DT or ET neoadjuvant chemotherapy. No drugs treatment in this group.

    Eligibility Criteria

            Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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
    Maximum Eligible Age:70 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:pCR rate
    Time Frame:2 years
    Safety Issue:
    Description:pCR rate in the DT and ET group

    Secondary Outcome Measures

    Measure:Efficacy of neo-adjuvant chemotherapy
    Time Frame:5 years
    Safety Issue:
    Description:5-year DFS in the DT and ET group
    Measure:Efficacy of sequential chemotherapy
    Time Frame:6 years
    Safety Issue:
    Description:5-year DFS of non- pCR patients treated by sequential NX regimen

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Tianjin Medical University Cancer Institute and Hospital

    Trial Keywords

    • breast cancer, neoadjuvant chemotherapy,susceptible gene

    Last Updated

    December 2, 2017