Using aseptic technique, 0.8 mL of E75 acetate solution (1136 mcg E75 peptide) is added to the re-constituted Leukine. Taking into account vial losses, this procedure will yield a total dose of approximately 1010 mcg of E75 peptide in a volume of 1.6 mL. Stability: Once prepared, administer the E75 peptide/placebo and lyophilized Leukine mixture within 6 hours. Materials: 1. Randomized Test Drug kit with Subject ID number. This kit contains either a single 1.0 mL vial of E75 acetate solution (1.5 mg/mL) or a single 1.0 mL vial of placebo. 2. Lyophilized Leukine kit with Subject ID number. This kit contains a single vial of lyophilized Leukine (250 µg). 3. Ancillary Supplies: 7-1.0 mL TB syringes, 5-3/8 inch 26G needles, 4-2 inch 21G needles, 2-3 mL luer lock syringes. Dose Preparation: NOTE: DO NOT INVERT ANY STUDY DRUG VIALS DURING PREPARATION 1. Remove cap from vial of SWFI and wipe septum with alcohol prep pad. 2. Remove cap from vial of lyophilized Leukine (250 µg) and wipe with alcohol prep pad. 3. Attach a 2 inch 21G needle to a 1.0 mL TB syringe and draw up 1.0 mL from the vial of SWFI. 4. Using the needle and syringe from step #3, insert the needle into the Leukine vial. • Angle the needle to the side of the Leukine vial and slowly expel 1.0 mL SWFI into the lyophilized Leukine. CONFIDENTIAL Page 87 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 • DO NOT INVERT VIAL at any time. Roll the vial slowly between your hands to mix, taking care to be sure all powder is dissolved in the vial. • Reconstitution of lyophilized Leukine should take approximately 2 minutes. DO NOT SHAKE OR VORTEX.