RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide

This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare
the efficacy and safety of SPI-2012 (a long acting myeloid growth factor) with pegfilgrastim
(Neulasta [NDC 55513-190-01] manufactured by Amgen) in breast cancer patients treated with TC
chemotherapy.

Approximately 400 patients will be enrolled and randomized in a 1:1 ratio to 2 treatment
arms.

Each cycle will be 21 days. Only 4 cycles will be evaluated for this study. On Day 1 of each
cycle, patients will receive TC chemotherapy. On Day 2 of each cycle, patients will receive
study drug (SPI-2012 or pegfilgrastim).

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.