Abstract
Abstract Neratinib is an oral, small molecule which acts as an irreversible inhibitor of the pan ErbB receptor tyrosine kinase. Dual ErbB blockade combined with chemotherapy improves efficacy in Her-2 positive breast cancer. Both NeoALTTO (Lancet 2012) and Neosphere (Lancet Oncol 2012) trials demonstrated higher pCR for Her-2 positive breast cancer receiving dual anti-Her-2 neoadjuvant blockade therapy. The purpose of this trial is to determine the activity and safety profile of Neratinib as mono-blockade or in combination with Trastuzumab as dual blockade in neoadjuvant therapy of locally advanced breast cancer (stage IIB, III A, B and C). Methods: This NSABP Foundation Research Program study (FB-7) is designed as a Phase II, multi-center, three arm clinical trial for patients with Her-2 positive locally advanced breast cancer. 126 patients will be enrolled. The initial two- arm study of Neratinib or Trastuzumab in combination with Paclitaxel began in December 2010. 30 patients were enrolled by December of 2011 at which time the study was placed on hold awaiting the recommended phase II dose of the three drug combination, Neratinib, Trastuzamab and Paclitaxel (NSABP FB-8 trial), which is a Phase I dose-escalation study in women with metastatic Her-2 positive breast cancer. The amended FB −7 trial is now a three arm trial of weekly Paclitaxel and Neratinib or Trastuzumab or Neratinib and Trastuzumab for 4 cycles followed by Doxorubicin and Cyclophosphamide for 4 cycles prior to surgical resection. Patients will then receive postoperative Trastuzumb to complete one total year of Her-2 blockade therapy. The primary goal of this study is to determine the pathologic complete response in breast and axillary lymph nodes following completion of neoadjuvant therapy. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr OT1-1-12.
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