Abstract S1-02: Final analysis of a phase II 3-arm randomized trial of neoadjuvant trastuzumab or lapatinib or the combination of trastuzumab and lapatinib, followed by six …

Abstract:

BACKGROUND: The BCIRG006 study (Slamon, et al. N Engl J Med 2011) demonstrated similar efficacy and superior safety of adjuvant docetaxel, carboplatin, and trastuzumab (TCH) over an anthracycline regimen in HER2+ BC. Dual HER2-blockade with lapatinib (Ty) and H demonstrated synergism preclinically and significant activity in the metastatic and neoadjuvant settings (Blackwell, et al. J Clin Oncol 2012; Baselga, et al. Lancet 2012). This study evaluates the clinical and molecular effects of neoadjuvant TC plus H and/or Ty in HER2+ BC. METHODS: This is an open-label, randomized phase II study in which pts with stage I-III, operable BC were assigned to 1 of 3 arms: Arm 1-TCH, Arm 2-TCTy, and Arm 3-TCHTy. To test the safety of TCHTy, the first 20 pts received TCHTy. The remaining pts were randomized (1:1:1) to the 3 arms. Pts received a run-in cycle of Ty (1000 mg/d days 1-21) and/or H (8 mg/kg iv …

Año de publicación:

2013

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Fuente:

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