Houston Street, Floor 7 San Antonio, TX 78205 Protocol Version/Date: 2.1/11 April 2016 Protocol Number: 2014-0443 2 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 Table of Contents Page 1. INTRODUCTION 4 1.1 Disease background 4 1.2 HER2-positive breast cancer 4 1.3 Nelipepimut-S 8 1.4 Combined HER2-directed therapy 11 2.