Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Condition: Breast Cancer; Neutropenia
MeSH terms: Breast Neoplasms; Neutropenia
Intervention: F-627; Neulasta
Intervention description: single dose pre-filled syringe; single dose pre-filled syringe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 393.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3
      study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive
      breast cancer receiving chemotherapy treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Show evidence of a personally signed and dated informed consent document indicating
             that the patient has been informed of all pertinent aspects of the trial.

          2. Females ≥18 years of age.

          3. Diagnosed with Stage I-III breast cancer.

          4. Subject is scheduled to undergo 4 cycles of neoadjuvant or adjuvant TC chemotherapy
             (docetaxel, cyclophosphamide, 75, 600 mg/m2, respectively).

          5. ECOG Performance status of ≤2.

          6. WBC count ≥4.0 × 109/L, hemoglobin ≥11.5 g/dL and a platelet count ≥150 × 109/L.

          7. Demonstrate adequate renal, hepatic, and cardiac function (liver function tests
             [alanine aminotransferase {ALT}, aspartate aminotransferase {AST}, alkaline
             phosphatase, and total bilirubin]) should be less than 2.5x the 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 intramuscular
             injection, or oral contraceptive, which has been started at least one month prior to
             visit one and will continue for the duration of the trial. The contraceptive patch or
             condom use with spermicide is also acceptable forms of contraception as long as they
             will be used continually throughout the duration of the trial.

        Exclusion Criteria:

          1. Subject is <18 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 in
             remission.

          6. Subjects that have used G-CSF or any other drug that may potentiate the release of
             neutrophils (i.e., lithium) within 6 weeks of the screening period are excluded.

          7. Subject has had chemotherapy within 180 days of screening.

          8. Subject has documented congestive heart failure, cardiomyopathy or myocardial
             infarction by clinical diagnosis, electrocardiogram (ECG) test, or any other relevant
             test.

          9. History of alcohol or drug abuse that would interfere with the ability to be compliant
             with the study procedure.

         10. Unwillingness to participate in the study.

         11. Any underlying medical condition that, in the Investigator's opinion, would make the
             administration of study drug hazardous to the patient or that would obscure the
             interpretation of adverse events.

         12. Receiving other investigational drugs or biologics within 1 month or five half lives
             of enrollment (if known), which ever is less.

         13. Any condition, which can cause splenomegaly.

         14. Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel
             disease.

         15. ALT, AST, alkaline phosphatase, total bilirubin ≥2.5x ULN.

         16. Subject with active infection, or known to be infected with chronic active Hepatitis B
             within the last 1 year (unless shown at the time of study entry to be Hepatitis B
             antigen 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 or
             a known immunodeficiency disorder.

         19. Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have
             received a prior chest X-ray for suspicion of tuberculosis are also excluded unless
             they have been confirmed to be PPD negative or they had latent tuberculosis that has
             been 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.