Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy (NCT06711523) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy
China250 participantsStarted 2025-01-09
Plain-language summary
To evaluate the efficacy, safety, and immunogenicity of PEG-G-CSF Injection (Kexing Biopharmaceutical Co., Ltd.) for the prevention of neutropenia after chemotherapy, using the PEG-G-CSF Injection ( Neulasta®, Amgen Europe B.V.) as a positive control.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Age ≥18 years, ≤75 years
✓. Female breast cancer patients with a pathohistologically confirmed diagnosis requiring first-time adjuvant or neoadjuvant chemotherapy and for whom the following regimens are appropriate: ①EC regimen (epirubicin 90 mg/m2 iv day 1, cyclophosphamide 600 mg/m2 iv day 1) ② TC regimen (cyclophosphamide 600 mg/m2 iv day 1, docetaxel 75 mg/m2 iv day 1) ③ TCb regimen ( docetaxel 75 mg/m2 iv day 1, carboplatin AUC=5 iv day 1); Note: TCb regimens such as the combination of anti-HER2 targeting drugs H (trastuzumab) and P (pertuzumab) can also be included.
✓. Physical condition ECOG score ≤ 1;
✓. Weight ≥ 45kg;
✓. Peripheral blood cell counts eligible for chemotherapy: white blood cell (WBC) count ≥ 3.5 x 109/L, neutrophil count (ANC) ≥ 1.5 x 109/L, hemoglobin (HB) ≥ 90 g/L, platelet (PLT) count ≥ 100 x 109/L, normal coagulation or abnormalities of no clinical significance, and no tendency to bleed;
✓. Survival is expected to be 6 months or more;
✓. The subject is willing to use an appropriate method of contraception for the duration of the trial;
✓. Subjects agreed to follow the trial treatment protocol and visit schedule, enrolled voluntarily, and signed a written informed consent form.
Exclusion criteria
✕. The subjects who have received radiation therapy within 4 weeks prior to randomization;
✕. Those who have received hematopoietic stem cell transplantation or bone marrow transplantation
What they're measuring
1
Duration of 4th degree neutropenia during chemotherapy cycle 1
Timeframe: At the end of Cycle 1 (each cycle is 21 days)
✕. Patients who have been treated with G-CSF analogs or PEG-G-CSF analogs within 4 weeks prior to randomization;
✕. Subjects with a history of chronic granulocytic leukemia or myelodysplastic syndromes;
✕. People at high risk for ARDS;
✕. Patients with unexplained splenomegaly on physical examination and/or CT scan or ultrasound, as well as any condition that may cause splenomegaly (e.g., thalassemia, glandular fever, malaria, etc.);
✕. Patients who currently have or have had sickle cell anemia;
✕. Those with a combined history of malignant tumors (except for the following: cured non-melanoma skin cancer, cervical cancer in situ, limited prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years);