neutropenia
Conditions
Interventions
Study group:In the first EC chemotherapy cycle, subjects will receive efbemalenograstim a (20 mg, subcutaneous injection) 24 ± 4 hours after the end of chemotherapy administration. In all subsequent c
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Show evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial. (2) Female =18 years of age and <75 years of age. (3) Confirmed by histopathology or cytology as breast cancer. (4) Adjuvant chemotherapy regimens are planned after breast cancer surgery: EC regimen (recommended dose: epirubicin 90 mg/m2, d1; cyclophosphamide 600 mg/m2, d1), 4 cycles, each cycle of 21 days. (5) Eastern Cooperative Oncology Group (ECOG) Performance status of =1. (6) ANC = 2.0 × 109/L, hemoglobin = 11.0 g/dL, and a platelet count = 80 × 109/L ( No blood transfusion within 14 days, not corrected with G-CSF and other hematopoietic stimulators). (7) Demonstrated adequate renal, hepatic function (liver function tests [alanine aminotransferase (ALT), aspartate aminotransferase (AST)]) should have been less than 2.5 × upper limit of normal (ULN). Serum creatinine and total bilirubin should have been less than 1.5 × ULN. (8) Left heart ejection fraction greater than or equal to 50%. (9) All subjects must have agreed to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which had been started at least one month prior to visit one and continued for the duration of the trial. The contraceptive patch or condom use with spermicide was also an acceptable form of contraception as long as they were used continually throughout the duration of the trial. (10) Researchers have determined that subjects can tolerate efbemalenograstim alfa treatment.
Exclusion criteria
Exclusion criteria: (1) Subject had undergone radiation therapy within 4 weeks. (2) Subject had undergone bone marrow or stem-cell transplantation. (3) Subject suffered from other malignant tumors than primary breast cancer. The following two situations can be recruited: subject achieved disease free survival (DFS) for 5 consecutive years with other malignant tumors treated with a single surgery; Subject had previously suffered from cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Ti (carcinoma in situ), and T1 (tumor infiltrating basement membrane)] but was cured. (4) Subjects that had used G-CSF within 6 weeks or traditional Chinese medicine that may potentiate the release of neutrophils within 4 weeks. (5) Has a known history of active serious cardiovascular disease: Myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval =470 ms); According to the New York Heart Association (NYHA) criteria, grade III.~IV cardiac insufficiency, or cardiac color ultrasound showed left ventricular ejection fraction (LVEF) < 50%. (6) Any condition which could cause splenomegaly, such as various acute and chronic infectious diseases, liver cirrhosis, chronic right heart failure, portal vein thrombosis, chronic constrictive pericarditis, Banti's syndrome; Various types of leukemia, malignant lymphoma, hemophilic syndrome; Disseminated lupus erythematosus, dermatomyositis, polyarteritis nodosa, juvenile rheumatoid arthritis; Gaucher disease, eosinophilic granulomas; Splenic artery aneurysm, lymphangioma,dermoid cysts, etc.; (7) Subject with active infection, or known to be infected with chronic active Hepatitis B, or having any history of Hepatitis C. (8) Women who were pregnant or breast-feeding. (9) Subject known to be seropositive for human immunodeficiency virus (HIV), or who had had an acquired immunodeficiency syndrome (AIDS) defining illness or a known immunodeficiency disorder. (10) Subject with a history of tuberculosis (TB) or exposure to TB. Subjects that had received a prior chest X-ray for suspicion of TB were also excluded unless they had been confirmed to be purified protein derivative (PPD) negative or they had latent TB that has been previously treated. (11) Subject with sickle cell anemia, aplastic anemia, thalassemia, myelodysplastic syndrome, and myelofibrosis. (12) History of alcohol or drug abuse that would have interfered with the ability to be compliant with the study procedure. (13) Subject with known hypersensitivity to pegfilgrastim‚ filgrastim, or any other component of the study drug. (14) Received other investigational drugs or biologics, the following conditions may be enrolled: The last use of other investigational drugs has exceeded 1 month or 5 half-lives of other investigational drugs (whichever is longer). (15) Any underlying medical condition that, in the Investigator’s opinion, would have made the administration of study drug hazardous to the subject or that would have obscured the interpretation of AEs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade = 3 neutropenia (ANC< 1.0× 109/L) throughout EC chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration (days) of = grade 3 (ANC<1.0×109/L) neutropenia in each chemotherapy cycle and throughout EC chemotherapy;Incidence of neutropenia = grade 3 (ANC<1.0×109/L) in each cycle of chemotherapy.;Incidence and duration of neutropenia = grade 2 (ANC<1.5×109/L) in each chemotherapy cycle and throughout EC chemotherapy. ;Incidence of febrile neutropenia (FN) in each chemotherapy cycle and throughout EC chemotherapy. ;Nadir of ANC for each chemotherapy cycle and throughout the EC chemotherapy period; | — |
Countries
China
Contacts
Public ContactPan Yueyin
Anhui Provincial Cancer Hospital
Outcome results
None listed