• 455 patients (who also received chemotherapy): pCR significantly higher with the combination of L and T (51.3%) versus T alone (29.5%). No difference between T alone and L alone (24.7%).
• L associated with more Grade 3 diarrhea and liver enzyme alterations.

When this landmark study was first presented at the 2010 San Antonio Breast Cancer Symposium along with 2 other major randomized neoadjuvant trials, there was a great deal of excitement, but 2 years later it's not clear how these findings have impacted current management or will impact the treatment of these patients in the future. NeoALTTO demonstrated greater antitumor effect with chemo/trastuzumab/lapatinib than with chemo with either agent alone, but few if any researchers have adopted this approach outside a trial setting. On a related note, while it was originally hoped that this neoadjuvant study would provide an early hint as to what might emerge from the massive international adjuvant trial of similar name and design, the rapid influx of more exciting approaches to HER2-positive disease including pertuzumab and T-DM1 has made some wonder whether the ALTTO data will be outdated when finally available. Nonetheless the study fits into the evolving paradigm of combined anti-HER2 treatment.