Phase 2 Study of HM10460A or Pegfilgrastim Use for the Management of Neutropenia in Breast Cancer Patients

This is an open label, multicenter, dose ranging study, sequentially enrolled by study dose,
with a non-inferiority design to compare the effectiveness of HM10460A relative to a fixed
dose of pegfilgrastim as a concurrent active control to each dose of HM10460A in patients
with breast cancer. The study will include 4 arms: 3 dose levels of HM10460A versus
pegfilgrastim. The start of study treatment is defined as the initiation of HM10460A or
pegfilgrastim. The duration of treatment consists of a maximum of 4 cycles, which begin on
Day 1 with chemotherapy administration and continue through Day 21.

The planned number of patients is a total of 144 based on 36 enrolled into each of 4
treatment arms. The target population are patients with breast cancer who are candidates for
neoadjuvant or adjuvant treatment with TC chemotherapy. All patients who receive at least 1
dose of either HM10460A or pegfilgrastim will be followed for safety through 20 (± 2) days
after their last dose of study treatment or until all treatment-related AEs have resolved or
returned to baseline/Grade 1, whichever is longer, or until it is determined that the
outcome will not change with further follow-up.

Inclusion Criteria:

- Histologically confirmed breast cancer who is a candidate for adjuvant or neoadjuvant
chemotherapy

- Candidate for docetaxel and cyclophosphamide chemotherapy

- Female or male ≥ 18 years of age

- ECOG ≤ 2

- ANC ≥ 1.5 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Creatinine ≤ 1.5 x upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dL (≤ 25.65 μmol/L)

- AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN

- Hemoglobin > 9 g/dL

- Alkaline phosphatase ≤ 1.5 x ULN

Exclusion Criteria:

- Known sensitivity to E. coli derived products or known sensitivity to any of the
products to be administered during dosing

- Known HIV infection

- HBV or HCV diagnosis with detectable viral load or immunological evidence of chronic
active disease

- Active infection or any serious underlying medical condition, which would impair the
ability of the patient to receive protocol treatment

- Prior bone marrow or stem cell transplant

- Prolonged exposure to glucocorticosteroids and immunosuppressive agents