ETNA (Evaluating Treatment with Neoadjuvant Abraxane) randomized phase III study comparing neoadjuvant nab-paclitaxel (nab-P) versus paclitaxel (P) both followed by anthracycline regimens in women with HER2-negative high-risk breast cancer: A MICHELANGO study.

Abstract

502Background: Neoadjuvant chemotherapy regimens employing anthracyclines and taxanes have reported essentially doubled pCR rates with the addition of a taxane after anthracycline combinations. A reverse sequence did not reduce activity. nab-Paclitaxel (nab-P) is an albumin-bound nanoparticle of paclitaxel (P) that allows for safe infusion without premedication, and led to a significantly higher rate of pCR in the GeparSepto trial (Untch et al, Lancet Oncol 2016). Methods: This multicenter open label study (NCT01822314) in collaboration with GEICAM and BCRC-WA randomized 695 patients with centrally-confirmed HER2-negative breast cancer to P 90 mg/m2 (349 patients) or nab-P 125 mg/m2(346 patients). The two drugs were given on weeks 1, 2 and 3 followed by 1-week rest for 4 cycles before 4 cycles of an anthracycline regimen per investigator choice. Results: The ITT analysis of the primary endpoint pCR (absence of invasive cells in breast and nodes) along with the overall objective clinical response after sys...