SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and 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 for adjuvant or neo-adjuvant TC chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Absolute neutrophil count (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
Aspartate aminotransferase (AST) / Serum glutamic oxaloacetic transaminase (SGOT) and Alanine aminotransferase (ALT)/Serum glutamic pyruvic transaminase (SGPT) <=2.5×ULN (upper limit of normal)
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
Locally recurrent/metastatic breast cancer
Known sensitivity to E. coli-derived products
Concurrent adjuvant cancer therapy
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, receiving anti-infectives, or any underlying medical condition that would impair ability 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• Radiation therapy within 30 days prior to enrollment
Major surgery within 30 days prior to enrollment