Chemotherapy-Induced Neutropenia Febrile Neutropenia
Conditions
Interventions
Experimental group:PEG-rhG-CSF is administered with delayed dosing, with the day of chemotherapy counted as day 1 (D1). On day 7 (D7) of the first chemotherapy cycle, PEG-rhG-CSF 6mg is injected subcu
Control Group:Control group conventional medication regimen: On day 3 (D3) of the first chemotherapy cycle, subcutaneously inject PEG-rhG-CSF 6 mg (2 mg if using Pegkin).
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Female breast cancer patients; 2.Aged 18-70; 3.Kahlil's Functional Status Score (KPS) >=70; 4.All were required to receive >=4 cycles of adjuvant chemotherapy with EC as the starting regimen after breast cancer surgery (one cycle in 21 days), with chemotherapy doses and regimens recommended by national and international guidelines (including EC, EC-T, EC-TCb, EC-TH, EC-THP, etc.); 5.Neutrophil count (WBC) >= 2.0 x 10^9/ L, haemoglobin (Hb) >= 9 g / dl, platelet count (PLT) >= 100 x 10^9 / L, and no other haematological disorders; 6.Alanine aminotransferase (ALT), aspartate aminotransferase (AST) within 1.5 times the upper limit of normal, alkaline phosphatase (ALP) within 2.5 times the upper limit of normal, total bilirubin (TBIL) within 1.5 times the upper limit of normal; 7.Blood creatinine (Scr) is within 1.5 times the upper limit of normal; 8.The patient (or legal representative) signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Weight =2; 8.taking glucocorticoids; 9.Known hypersensitivity to anthracyclines, cyclophosphamide, paclitaxel, trastuzumab or patuximab; 10.Refusal of contraception by women of childbearing age during treatment and for 8 weeks after completion of treatment; 11.Pregnant and lactating women; 12.Pregnancy test (+) prior to dosing after enrolment testing; 13.Mental illness, cognitive impairment, inability to understand the test programme and side effects, inability to complete the test programme and follow-up workers (systematic assessment is required prior to trial enrolment); 14.Lack of personal freedom and independent civil capacity; 15.He investigator determines that long-term follow-up data are not available for the patient (due to unavailability or serious concomitant illness).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 3-4 neutropenia (CIN) in 4 EC chemotherapy cycles; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse reactions after injection of PEG-rhG-CSF, including bone pain, arthralgia, muscle pain, etc.;Reduction rate of PEG-rhG-CSF;Incidence of granulocytopenic fever (FN) in 4 EC chemotherapy cycles;;Incidence of grade 4 neutropenia (CIN) in 4 EC chemotherapy cycles;; | — |
Countries
China
Contacts
Public ContactWang Jue
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed