5%, a sample size of 150 patients per arm would be required or a study size of 300 patients (see statistical plan). 3.3 OUTCOME MEASURES 3.3.1 Primary Outcome Measure The primary clinical outcome of DFS will be determined by patients’ own physicians in the medical and surgical and/or the hematology/oncology clinics at the individual study sites during their routine follow-up screening. This will occur for all enrolled patients, regardless of randomization, approximately every three months for the first 24 months after completion of primary therapies and every six months thereafter with clinical exam, laboratory and radiographic surveillance (e.g., CT, bone, and mammographic scans) as indicated. This follow-up strategy is standard of care for these patients. If records are not available, patients, or their referring physicians, will be contacted to discern their disease status. All enrolled patients, regardless of randomization, will be followed for clinical recurrence for three years after initiation of Herceptin therapy. The recurrence rate and time to recurrence from date of initial Herceptin treatment for the patients randomized to receive Herceptin + E75/GM-CSF will be compared to the cohort of patients randomized to receive Herceptin + GM-CSF alone. The primary objective of the trial is DFS at 24 months with a secondary objective of DFS at 36 months. CONFIDENTIAL Page 17 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 3.3.2 Secondary Outcome Measures Secondary outcome measures include immunologic responses and safety of combination HER2 therapy. Immune responses will be primarily documented using the DTH reaction but also may be measured using the dimer assay and ELISPOT assay.