BOLERO-1: A Randomized, Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination With Trastuzumab and Paclitaxel as First-Line Therapy in Women With HER2-Positive (HER2 + ), Locally Advanced or Metastatic Breast Cancer (BC)

摘要

Eribulin mesylate is a non-taxane inhibitor of microtubule elongation that has shown single-agent clinical activity in breast cancer and other solid tumors. This open-label, multicenter, phase II clinical trial of 30 patients with stage l-lll, histologically confirmed, triple-negative breast cancer is investigating eribulin plus carbopla-tin in the neoadjuvant setting (Abstract TPS1134). The primary endpoint of the trial is to determine the partial complete response in the enrolled patient population. Secondary endpoints include determination of the clinical response rate, toxicity, and measurement of TLE3 as a biomarker of response to eribulin treatment. Patients will receive a total of 4 cycles of treatment administered every 3 weeks. The first 10 patients will receive eribulin (1.4 mg/m2 administered over 2-5 minutes) on days 1 and 8 followed by carboplatin (area under the curve of 6 administered over 30 minutes) on day 1. After enrollment of the first 10 patients, the study will be suspended temporarily for data analysis. If the safety evaluation shows more than 60% grade 3 or 4 neutropenia or more than 15% grade 3 or 4 peripheral neuropathy, then the dose of eribulin will be reduced to 1.1 mg/m2. Definitive surgery will be performed 3-8 weeks after the end of treatment.