Neoadjuvant Paclitaxel Plus Epirubicin Versus Vinorelbine Plus Epirubicin in Breast Cancer With TEKT4 Variations

Sponsor
Fudan University
Study ID
NCT02628613
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine plus Epirubicin — DRUG
    Evaluate the efficiency and safety of vinorelbine plus epirubicin as neoadjuvant chemotherapy in locally advanced HER2-negative breast cancer with TEKT4 variations
  • Paclitaxel plus Epirubicin — DRUG
    standard neoadjuvant chemotherapy

Study Details

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.

Key Dates

Start date
Dec 31, 2015
Status verified
Oct 2019
Primary completion
Feb 28, 2019
Completion
Feb 28, 2019

Study Design

Enrollment
91 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Paclitaxel plus Epirubicin
    Paclitaxel plus Epirubicin for 4 cycles, 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.
  • Experimental: Vinorelbine plus Epirubicin
    Vinorelbine plus Epirubicin for 4 cycles, 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.

Primary Outcome Measure

pathologic Complete Response (pCR) [ Time Frame: 3 years ]

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