Clinical trial NCT03404752 (phase 3, status: unknown status)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: peg-filgrastim
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Female patients aged 18 to 70 years old.

          -  Patients diagnosed having high risk stage 2 or stage 3 or 4 of breast cancer (by
             histopathological or cytological diagnosis) and need neoadjuvant, adjuvant
             chemotherapy, or with metastatic disease.

          -  A priori has been decided to be treated with Peg-Filgrastim and subjects eligible for
             Peg-Filgrastim therapy according to indications and clinical use in the product
             monograph

          -  Patients scheduled to receive 4 or 6 cycles of chemotherapy (Taxane combinations) with
             prophylactic Peg-Filgrastim at 3 weeks interval. Monoclonal Antibodies in addition to
             Taxane regimens are permitted.

          -  Any acute adverse effects of prior therapy must have resolved to ≤ NCI CTCAE (Version
             4.0) grade 1 (excluding alopecia) prior to Day 1 of Cycle 1

          -  Eastern Cooperative Oncology Group - ECOG Performance Status 0, 1 or 2 as determined
             on Day 1 or up to -3 of Cycle 1 prior to administration of chemotherapy

          -  Patients must have adequate organ function including the following:

               1. Adequate bone marrow functions, as determined within 3 days prior to
                  administration of chemotherapy on Day 1 of Cycle 1 and as indicated by Hb ≥9,5
                  g/dl (transfusion permitted to be included in the trial ),WBC (white blood cell)
                  ≥3,5 x 109/l, Absolute neutrophil count (ANC) ≥1.5 x 109/l, Platelets ≥95 x
                  109/l;

               2. Adequate renal and hepatic function, as determined within 3 days prior to
                  administration of chemotherapy on Day 1 of Cycle 1 and defined as follows,

                    1. Hepatic: Bilirubin ≤ 1.5 x the upper limit of normal (ULN) (unless elevation
                       is known to be due to Gilbert's disease), Subjects must also meet one of the
                       following criteria:

                         1. Alkaline phosphatase within normal reference range and both AST
                            (aspartate aminotransferase) and ALT (alanine aminotransferase) >2.5 x
                            ULN; or

                         2. Alkaline phosphatase <2.5 x ULN and both AST and ALT <1.5 x ULN; or

                         3. Alkaline phosphatase <5 x ULN and both AST and ALT within normal
                            reference range;

                    2. Renal: Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≤ 60 ml/min
                       (calculated according to the Cockcroft and Gault formula)

          -  Patients of child-bearing potential must have a negative pregnancy test within 3 days
             prior to the first dose of chemotherapy and at day 1 or up to -3 days of each Cycle)
             and use at least one form of contraception as approved by the investigator during the
             study.

          -  Life expectancy >6 months

        Exclusion Criteria:

        Safety of treatment dependent criteria:

          -  Presence of any serious concomitant systemic disorders incompatible with the
             administration of filgrastim, Peg-Filgrastim or any systemic disease that can
             influence the patient's safety according to doctor's diagnosis.

          -  History of hypersensitivity to Peg-Filgrastim, filgrastim or E.coli derived proteins.

          -  Serious local infection or active systemic infection within 10 days prior to
             enrollment or patients who have taken antibiotics within the previous 10 days

          -  Pregnant or breast-feeding patients

          -  Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or
             advanced ischemic heart disease (NYHA III or IV)

          -  Known bleeding disorder

          -  Patient known to have HIV, Hepatitis B, Hepatitis C or who have a positive serology
             for HIV, Hepatitis B or Hepatitis C at screening

          -  History or presence of sickle cell disease

          -  Concurrent or prior radiotherapy within four weeks of randomization

        Criteria dependent on compliance with study procedures, or the evaluation of the response:

          -  Unwilling to use a reliable and acceptable contraceptive method throughout the study
             period (fertile patients only)

          -  Treatment with certain other agents to treat the malignant disease

          -  Known drug addiction, including alcoholism

          -  Treatment with any investigational product within 30 days prior to study drug
             administration

          -  Concurrent prophylactic antibiotics

          -  Previous participation in this study.

          -  Already involved in another trial.

          -  History of bone marrow or stem cell transplantation.

          -  Previous therapy should not have included G-CSF (granulocyte-colony stimulating
             factor)

        Previous participation in this study: Subjects who are considered screening failures are
        allowed to be re-screened, except if have started chemotherapy. In case of re-screening the
        following assessments and evaluations do not have to be repeated: Demographics, Medical
        history, HIV, Hepatitis B and C serology.