Efficacy results of node-negative HER2-amplified breast cancer subset from BCIRG 006 study: A phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC-T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC-TH) with docetaxel, carboplatin, and trastuzumab (TCH).

Abstract

553 Background: Trastuzumab-chemotherapy-based adjuvant therapy (AC-TH or TCH) provide significant improvement in disease-free survival (DFS) and overall survival (OS) compared to chemotherapy-based adjuvant therapy (AC-T) in HER2 amplified breast cancer [Rommond E et al NEJM 2005 and Slamon D et al SABC 2009 and NEJM 2011 (in press)]. BCIRG 006 included 928 patients (pts) with stage I or II node-negative high risk HER-2 amplified breast cancer. We reported patient and tumor characteristics and efficacy outcome [disease-free survival (DFS) and overall survival (OS)] of this subset of pts. Methods: Pts were randomized to either AC (60/600 mg/m2 q3wk ×4) followed by T (100 mg/m2 q3wk × 4) or AC followed by TH × 4 (H q1wk during chemotherapy then q3wk × 9 months) or TCH (75 mg/m2 / AUC6 q3wk × 6, and H q1wk during chemotherapy then q3wk × 7.5 months). High risk axillary node negative HER-2 amplified breast cancer was prospectively defined as any of these patient/tumor characteristics: age ≤35 years, or tumor...