Abstract OT1-1-01: A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab for node-positive breast cancer

Abstract

Abstract Background: Paclitaxel is considered standard treatment for metastatic breast cancer (MBC) and is often used as adjuvant and neoadjuvant chemotherapy for patients with early-stage disease. Conventional paclitaxel requires solvents such as polyoxyethylated castor oil; however, such solvents are associated with toxicity including peripheral neuropathy and hypersensitivity reaction. Moreover, the use of the drug requires special tubing and in-line filters. Therefore, nanoparticle albumin-bound paclitaxel (nab-PTX) requiring no solvent has been developed. Nab-PTX was effective in patients with MBC and as a neoadjuvant therapy. A comparison between weekly and triweekly nab-PTX suggested that weekly nab-PTX was superior in progression-free survival. Trial design: This is a phase II trial to evaluate the efficacy and toxicity of neoadjuvant epirubicin/cyclophosphamide (EC) (epirubicin/cyclophosphamide) followed by weekly nab-PTX with or without trastuzumab for node-positive breast cancer. Patients receive four cycles of epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) every 3 weeks, followed by four cycles of nab-PTX (125 mg/m2) on days 1, 8 and 15 in a 28-day cycle. Fifteen cycles of trastuzumab (2 mg/kg, loading 4 mg/kg) are added to the nab-PTX regimen in HER2-positive patients every week. Eligibility criteria: Patients with histologically diagnosed invasive breast cancer based on a core needle biopsy of the T1-4 N1-3 without previous operation or chemotherapy are included in this trial. Eligible patients are aged between 20 years and 70 years with a performance status of 0 to 2 and adequate organ functions. Specific aims: The primary endpoint is the pathologic complete response (pCR) rate in the breast and axilla, and the secondary endpoints are the breast conserving rate, toxicities, feasibility and overall survival. Statistical methods: The sample size was calculated using the Simon method, with a type I error of 10% and a study power of 80%. 1. HER2-negative patients The expected rate of pCR was 25% and the required number of patients was estimated to be 33. 2. HER2-positive patients The expected rate of pCR was 50%, and the required number of patients was estimated to be 21. Present and target accrual: Patient accrual within two medical centers started in April 2011 with 20 patients being on study to date (2012, June 12). A total of 56 patients (22 are HER2-positive and 34 are HER2-negative) are planned to be enrolled in the trial. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr OT1-1-01.