SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)

Key Inclusion Criteria:

• New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined asoperable Stage I to Stage IIIA breast cancer
• Candidate for adjuvant or neoadjuvant TC chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
• Absolute neutrophil count (ANC) ≥ 1.5×10^9/L
• Platelet count ≥ 100×10^9/L
• Hemoglobin > 9 g/dL
• Creatinine clearance > 50 mL/min
• Total bilirubin ≤ 1.5 mg/dL
• Aspartate Aminotransferase per Serum Glutamic-Oxaloacetic Transaminase (AST/SGOT) andAlanine Aminotransferase per Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) ≤ 2.5×Upper Limit of Normal (ULN).
• Alkaline phosphatase ≤ 2.0×ULN

Key Exclusion Criteria:

• Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ ofthe cervix) or life-threatening disease
• Locally recurrent or metastatic breast cancer
• Known sensitivity to E. coli -derived products or to any products to be administeredduring dosing
• Concurrent adjuvant cancer therapy
• Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinicaldevelopment within 12 months prior to the administration of study drug
• Active infection, receiving anti-infectives, or any serious underlying medicalcondition that would impair ability to receive protocol treatment
• Prior bone marrow or stem cell transplant
• Use of any investigational drugs, biologics, or devices within 30 days prior to studytreatment 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