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 as operable 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) and Alanine 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 of the cervix) or life-threatening disease
* Locally recurrent or metastatic breast cancer
* Known sensitivity to E. coli -derived products or to any products to be administered during dosing
* 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 serious underlying medical condition 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 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