Abstract
BACKGROUND: Neoadjuvant chemotherapy (NAC) with anthracycline sequential paclitaxel is the standard regimen for triple negative breast cancer (TNBC), while TNBC with residual positive axillary lymph node after standard NAC indicates poor prognosis. There is no evidence that vinorelbine alone can be used as an adjuvant intensive therapy for such patients at present. METHODS: We recruited TNBC patients with clinical stage of T1-4/N1-3/M0, who received NAC with 8 cycles of anthracycline sequential paclitaxel and had residual tumor in axillary lymph node after surgery. The patients were randomly divided into adjuvant intensive treatment group (Group A) and control group (Group B). The patients in group A received vinorelbine at a dose of 25 mg/m(2) on days 1/8 of a 21-day cycle with four planned cycles, while the control group received no therapy. Stratified according to the Miller-Payne system of the primary lesion (G1-2/G3-5). The endpoints included distant disease-free survival (DDFS), recurrence-free survival (RFS), overall survival (OS), and safety. RESULTS: A total of 22 eligible patients were enrolled in this study, the 3-year DDFS and RFS rates in the group A were significantly higher than those in group B (90.0% vs. 42.4%, p = 0.022, both) at a median follow-up of 36 months. All patients in the group A completed the scheme in full dose, and no grade 3/4 adverse event occurred. CONCLUSIONS: TNBC patients with residual positive axillary lymph nodes after NAC of anthracycline sequential paclitaxel could benefit from adjuvant intensive therapy of vinorelbine with a good safety. TRAIL REGISTRATION: The study was registered on the Clinical Trial registry website ( https://register. CLINICALTRIALS: gov , NCT03270007) (Registration Date: 08/30/2017).