Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial

Hynes, 2005, ERBB receptors and cancer: the complexity of targeted inhibitors, Nat Rev Cancer, 5, 341, 10.1038/nrc1609 Slamon, 2001, Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2, N Engl J Med, 344, 783, 10.1056/NEJM200103153441101 Romond, 2005, Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer, N Engl J Med, 353, 1673, 10.1056/NEJMoa052122 Smith, 2007, 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial, Lancet, 369, 29, 10.1016/S0140-6736(07)60028-2 Joensuu, 2006, Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer, N Engl J Med, 354, 809, 10.1056/NEJMoa053028 Geyer, 2006, Lapatinib plus capecitabine for HER2-positive advanced breast cancer, N Engl J Med, 355, 2733, 10.1056/NEJMoa064320 Konecny, 2006, Activity of the dual kinase inhibitor lapatinib (GW572016) against HER-2-overexpressing and trastuzumab-treated breast cancer cells, Cancer Res, 66, 1630, 10.1158/0008-5472.CAN-05-1182 Xia, 2005, Combining lapatinib (GW572016), a small molecule inhibitor of ErbB1 and ErbB2 tyrosine kinases, with therapeutic anti-ErbB2 antibodies enhances apoptosis of ErbB2-overexpressing breast cancer cells, Oncogene, 24, 6213, 10.1038/sj.onc.1208774 Scaltriti, 2009, Lapatinib, a HER2 tyrosine kinase inhibitor, induces stabilization and accumulation of HER2 and potentiates trastuzumab-dependent cell cytotoxicity, Oncogene, 28, 803, 10.1038/onc.2008.432 Junttila, 2009, Ligand-independent HER2/HER3/PI3K complex is disrupted by trastuzumab and is effectively inhibited by the PI3K inhibitor GDC-0941, Cancer Cell, 15, 429, 10.1016/j.ccr.2009.03.020 Hudis, 2007, Trastuzumab—mechanism of action and use in clinical practice, N Engl J Med, 357, 39, 10.1056/NEJMra043186 Mohsin, 2005, Neoadjuvant trastuzumab induces apoptosis in primary breast cancers, J Clin Oncol, 23, 2460, 10.1200/JCO.2005.00.661 Dave, 2011, Loss of phosphatase and tensin homolog or phosphoinositol-3 kinase activation and response to trastuzumab or lapatinib in human epidermal growth factor receptor 2-overexpressing locally advanced breast cancers, J Clin Oncol, 29, 166, 10.1200/JCO.2009.27.7814 Blackwell, 2010, Randomized study of Lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer, J Clin Oncol, 28, 1124, 10.1200/JCO.2008.21.4437 Gianni, 2010, Lancet, 375, 377, 10.1016/S0140-6736(09)61964-4 Untch, 2011, Pathological complete response after neoadjuvant chemotherapy + trastuzumab treatment predicts survival and detects a patient subgroup at high need for improvement of anti-HER2 therapy: three year median follow-up data of the TECHNO Trial, Cancer Res, 70 Wolff, 2007, American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer, J Clin Oncol, 25, 118, 10.1200/JCO.2006.09.2775 Fisher, 2002, Pathobiology of preoperative chemotherapy: findings from the National Surgical Adjuvant Breast and Bowel (NSABP) protocol B-18, Cancer, 95, 681, 10.1002/cncr.10741 Lan, 1983, Discrete sequential boundaries for clinical trials, Biometrika, 70, 659, 10.2307/2336502 Hochberg, 1988, A sharper bonferroni procedure for multiple tests of significance, Biometrika, 75, 800, 10.1093/biomet/75.4.800 Cox, 1970 Moy, 2009, Hepatobiliary abnormalities in patients with metastatic cancer treated with lapatinib, J Clin Oncol, 27, 1043, 10.1200/jco.2009.27.15_suppl.1043 Gianni, 2012, Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial, Lancet Oncol, 13, 25, 10.1016/S1470-2045(11)70336-9 Crown, 2007, Safety and tolerability of lapatinib in combination with taxanes (T) in patients with breast cancer (BC), J Clin Oncol, 25, 1027, 10.1200/jco.2007.25.18_suppl.1027 Dang, 2010, Dose-dense doxorubicin and cyclophosphamide followed by weekly paclitaxel with trastuzumab and lapatinib in HER2/neu-overexpressed/amplified breast cancer is not feasible because of excessive diarrhea, J Clin Oncol, 28, 2982, 10.1200/JCO.2009.26.5900 Baselga, 2009, Novel anticancer targets: revisiting ERBB2 and discovering ERBB3, Nat Rev Cancer, 9, 463, 10.1038/nrc2656 Chang, 2011, TBCRC 006: A multicenter phase II study of neoadjuvant lapatinib and trastuzumab in patients with HER2-overexpressing breast cancer, J Clin Oncol, 29, 505, 10.1200/jco.2011.29.15_suppl.505 Holmes, 2011, Correlation of molecular effects and pathologic complete response to preoperative lapatinib and trastuzumab, separately and combined prior to neoadjuvant breast cancer chemotherapy, J Clin Oncol, 29, 506, 10.1200/jco.2011.29.15_suppl.506 Guarneri, 2011, Final results of a phase II randomized trial of neoadjuvant anthracycline-taxane chemotherapy plus lapatinib, trastuzumab, or both in HER2-positive breast cancer (CHER-LOB trial), J Clin Oncol, 29, 507, 10.1200/jco.2011.29.15_suppl.507 Untch, 2012, Lapatinib versus trastuzumab in combination with neoadjuvant anthracycline-taxane-based chemotherapy (GeparQuinto, GBG 44): a randomised phase 3 trial, Lancet Oncol, 10.1016/S1470-2045(11)70397-7