Three-arm randomized phase II study evaluating oral vinorelbine plus capecitabine versus paclitaxel plus gemcitabine versus docetaxel plus gemcitabine as first-line chemotherapy in patients with metastatic breast cancer: Final results (NorCap-CA223 trial).

1044 Background: Combination chemotherapy (CT) is among the standard treatment options in metastatic breast cancer (MBC), especially in patients (pts) with visceral metastases or need of rapid symptom or disease control. Full oral combination CT of Oral Vinorelbine (OV) + Capecitabine (C) is a convenient and effective alternative to taxane-based intravenous regimens. Aim of this study was to evaluate the efficacy of a full oral and two full intravenous combinations in MBC. Methods: Pts with HER2-negative taxane-naive MBC, with an age ≥18 years were eligible. Pts were randomised to receive, as first-line CT, 3 weekly-cycles of either: ARM A: full oral combination of OV and C; ARM B: paclitaxel plus gemcitabine (G); ARM C: docetaxel plus G. Primary endpoint was disease control rate (DCR). Pts were stratified according to prior anthracycline CT and age < or ≥65 years. Results: 149 pts had been treated (ARM A 49; ARM B 50; ARM C 50). Baseline pt characteristics (Arms A/B/C): median age 58/56/57 years; prior (...