Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Inclusion Criteria:

1. Show evidence of a personally signed and dated informed consent document indicatingthat the patient has been informed of all pertinent aspects of the trial.
2. Females ≥ 18 years of age and < 75 years of age.
3. Diagnosed with Stage II-IV breast cancer.
4. Subject is scheduled to undergo 4 cycles of TA chemotherapy (docetaxel, doxorubicin, 75, and 60 mg/m2, respectively).
5. ECOG Performance status of ≤ 2.
6. White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a plateletcount ≥ 150 × 109/L.
7. Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkalinephosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
8. All subjects must agree to use at least one of the following types of contraception:intrauterine device, implantable progesterone device, progesterone intramuscularinjection, or oral contraceptive, which has been started at least one month prior tovisit one and will continue for the duration of the trial. The contraceptive patch orcondom use with spermicide is also acceptable forms of contraception as long as theywill be used continually throughout the duration of the trial.

Exclusion Criteria:

1. Subject is <18 or ≥ 75 years of age.
2. Disease progression has occurred while receiving a taxane regimen.
3. Subject has undergone radiation therapy within 4 weeks of enrollment.
4. Subject has undergone bone marrow or stem-cell transplantation.
5. Subject has a history of prior malignancy other than breast cancer that is NOT inremission.
6. Subjects that have used G-CSF or any other drug that may potentiate the release ofneutrophils (i.e. lithium) within 6 weeks of the screening period are excluded.
7. Subject has had chemotherapy within 365 days of screening.
8. Subject has documented congestive heart failure, cardiomyopathy or myocardialinfarction by clinical diagnosis, ECG test, or any other relevant test.
9. History of alcohol or drug abuse that would interfere with the ability to be compliantwith the study procedure.
10. Unwillingness to participate in the study.
11. Any underlying medical condition that, in the Investigator's opinion, would make theadministration of study drug hazardous to the patient or that would obscure theinterpretation of adverse events.
12. Receiving other investigational drugs or biologics within 1 month or five half livesof enrollment.
13. Any condition, which can cause splenomegaly.
14. Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory boweldisease.
15. ALT, AST, alkaline phosphatase, total bilirubin ≥ 2.5 upper limit of normal.
16. Subject with active infection, or known to be infected with chronic active Hepatitis Bwithin the last 1 year (unless shown at the time of study entry to be Hepatitis Bantigen negative), or having any history of Hepatitis C.
17. Women who are pregnant or breast-feeding.
18. Subject known to be seropositive for HIV, or who have had an AIDS defining illness ora known immunodeficiency disorder.
19. Subject with a history of tuberculosis or exposure to tuberculosis. Patients that havereceived a prior chest X-ray for suspicion of tuberculosis are also excluded unlessthey have been confirmed to be PPD negative or they had latent tuberculosis that hasbeen previously treated.
20. Subjects with Sickle Cell disease
21. Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim'filgrastim, or any other component of the study drug.