Neoadjuvant Paclitaxel Plus Epirubicin Versus Vinorelbine Plus Epirubicin in Breast Cancer With TEKT4 Variations
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficiency and safety between paclitaxel combined
      with epirubicin and vinorelbine combined with epirubicin when used in neoadjuvant
      chemotherapy for locally advanced (IIb-IIIc) HER2-negative breast cancer with TEKT4
      variations.
    

Detailed description: 
      Taxane-based chemotherapy is the cornerstone treating breast cancer, however remarkable
      percentage of breast cancer patients presents with primary or secondary taxane resistance.
      Currently no established biomarker has been reported clinically for predicting taxane
      sensitivity. Our previous study indicated that TEKT4 variation decreased the stability of
      intracellular microtubule, and TEKT4 variant cells behaves higher resistance to
      microtubule-stabilizing agents such as taxane, while enhanced sensibility to microtubule
      depolymerization agents such as vinorelbine. This study is intended to confirm that TEKT4
      variation predicts the prognosis of taxane-based chemotherapy through the prospective
      clinical trials.

      This study intends to evaluate the efficiency and safety of two neoadjuvant therapies:
      paclitaxel combined with epirubicin and vinorelbine combined with epirubicin, in treating
      locally advanced (IIb-IIIc) HER2-negative breast cancer with TEKT4 variation.

      Primary endpoint of study: pathologic Complete Response (pCR). Secondary endpoints of the
      study: Objective response rate (CR+PR). Exploratory endpoint: Based on pretreatment tumor and
      matched blood samples, the correlation between biomarker and efficiency is explored.

      This open single center prospective randomized control study includes patients locally
      advanced (IIb-IIIc) HER2-negative patients with TEKT4 variation diagnosed with histopathology
      and Sanger sequencing. Patients randomized to Group A or Group B to receive respective
      neoadjuvant chemotherapy. Among which Group A: PE x 4 cycles (paclitaxel + epirubicin),
      paclitaxel: 80 mg/m2 IV on day 1, 8 and 15; epirubicin: 90 mg/m2 IV on day 1, and dosing
      interval is 21 days. Group B: NE x 4 cycles (vinorelbine + epirubicin), vinorelbine: 25 mg/m2
      IV on day 1, 8 and 15; epirubicin: 90 mg/m2 IV on day 1, and dosing interval is 21 days.

      Patients of both groups were performed with diagnostic puncture before treatment and over
      half of treatment course in order to obtain information about dynamic change of Ki67 and
      other parameters; Surgery will be performed after 4 cycles of chemotherapy, followed with
      subsequent adjuvant therapy.
    

Intervention name(s): Vinorelbine plus Epirubicin; Paclitaxel plus Epirubicin
Intervention type(s): Drug; Drug
Intervention description(s): Evaluate the efficiency and safety of vinorelbine plus epirubicin as neoadjuvant chemotherapy in locally advanced HER2-negative breast cancer with TEKT4 variations; standard neoadjuvant chemotherapy
Intervention MeSH terms: Paclitaxel; Vinorelbine; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; Neoadjuvant chemotherapy; TEKT4