Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy

Inclusion Criteria:

* Newly diagnosed, histologically confirmed early-stage breast cancer, defined as operable Stage I to Stage IIIA breast cancer.
* Candidate to receive adjuvant or neoadjuvant TC chemotherapy.
* ANC ≥1.5x10\^9/L
* Platelet count ≥100x10\^9/L
* Hemoglobin \>9 g/dL
* Calculated creatinine clearance \>50 mL/min
* Total bilirubin ≤1.5 mg/dL
* AST and ALT ≤2.5xULN
* Alkaline phosphatase ≤2.0xULN
* ECOG ≤2

Exclusion Criteria:

* Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of cervix) or life-threatening disease. If history of prior malignancies or contralateral breast cancer, must be disease free for at least 5 years.
* 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 breast cancer.
* 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 antibiotics or any serious underlying medical condition which would impair the ability of the patient to receive protocol-specified treatment.
* Prior bone marrow or hematopoietic 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.