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.