Abraxane nab-paclitaxel: Phase III data

Top-line data from the open-label, international Phase III ETNA trial in 695 patients with HER2-negative, high-risk breast cancer showed that neoadjuvant treatment with once-weekly 125 mg/m 2 Abraxane for the first 3 weeks of each 4-week cycle for 4 cycles followed by 4 cycles of investigator’s choice of an anthracycline regimen missed the primary endpoint of improving pCR rate vs. paclitaxel followed by investigator’s choice of an anthracycline regimen (22.5% vs. 18.1%, HR=0.74, 95% CI: 0.5, 1.09, p=0.127). Abraxane followed by an anthracycline regimen also missed the secondary endpoint of improving ORR vs. paclitaxel followed by an anthracycline regimen (77.2% vs. 74.5%, HR=0.87, 95% CI: 0.61, 1.23, p=0.427). The trial was sponsored by Fondazione Michelangelo. Data will be presented at the American Society of Clinical Oncology meeting in Chicago. ...