['neutropenia', 'breast cancer']
['spi-2012', 'pegfilgrastim', 'docetaxel', 'cyclophosphamide']

        Key Inclusion Criteria:

          -  New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as
             operable Stage I to Stage IIIA breast cancer.

          -  Candidate to receive adjuvant or neo-adjuvant TC chemotherapy.

          -  ECOG ≤2.

          -  ANC ≥1.5×10^9/L

          -  Platelet count ≥100×10^9/L

          -  Hemoglobin >9 g/dL

          -  Calculated creatinine clearance > 50 mL/min

          -  Total bilirubin ≤1.5 mg/dL

          -  AST/SGOT and ALT/SGPT ≤2.5×ULN

          -  Alkaline phosphatase ≤2.0×ULN

        Key Exclusion Criteria:

          -  Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of
             the cervix) or life-threatening disease.

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

          -  Concurrent adjuvant cancer therapy

          -  Locally recurrent/metastatic

          -  Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical
             development within 12 months prior to the administration of study drug

          -  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

          -  Used any investigational drugs, biologics, or devices within 30 days prior to study
             treatment or plans to use any of these during the course of the study.

          -  Prior radiation therapy within 30 days prior to enrollment.

          -  Major surgery within 30 days prior to enrollment.
      