A randomized, parallel-arm, phase II trial to assess the efficacy of preoperative ixabepilone with or without cetuximab in patients with triple-negative breast cancer (TNBC).

1133 Background: Epithelial growth factor receptor pathway (EGFR) is expressed in TNBC and may be important in a subset of this heterogeneous disease. We evaluated the efficacy and toxicity of an anti-EGFR antibody (cetuximab) combined with ixabepilone given to the TNBC patients (pts) in the neoadjuvant setting. This study was designed to detect an increase in pathological complete response (pCR) rate, defined as no residual disease in the breast, from 20% to 40% in each arm, using a Simon optimal two stage design, with one-sided alpha=10% and power=80%. At least three responses out of 12 patients were needed to proceed with second stage for each arm. Methods: All pts received 4 cycles of preoperative ixabepilone 40 mg/m2 every 3 weeks. In addition, patients were randomized to receive either 12 infusions of weekly cetuximab (400mg/m2 on week 1, then 250 mg/m2) or not. Race, proliferation rate, and TILs was correlated with pCR. Results: To date, a total of36 pts with stage II-IIIA TNBC were enrolled. Media...