Food and Drug Administration (FDA) Good Clinical Practices (GCPs), and local and U.S. Army ethical and legal requirements. CONFIDENTIAL Page 22 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 4. MATERIALS AND METHODS 4.1 SUBJECTS Female patients (n=300) over the age of 18 years with a diagnosis of NP (or NN if negative for both ER and PR) breast cancer who have HER2 tumors which are 1+ or 2+ by IHC will be targeted. All patients will have completed primary surgical and medical therapies.