Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy

Launched by KEXING BIOPHARM CO., LTD. · Nov 27, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new injection called PEG-G-CSF, which aims to help prevent neutropenia, a condition where a person has a low number of white blood cells, after receiving chemotherapy for breast cancer. Neutropenia can make patients more vulnerable to infections, so finding effective ways to prevent it is important for those undergoing cancer treatment. The trial will compare PEG-G-CSF to a well-known treatment called Neulasta® to see how well it works and how safe it is for patients.

To be eligible for this study, participants need to be women aged between 18 and 75 who have been diagnosed with breast cancer and are about to start their first round of chemotherapy. They should be in good physical health and meet specific criteria regarding their blood counts. Participants will receive the injection and will be monitored throughout the trial to assess its effects. This study is an opportunity for women dealing with breast cancer to contribute to research that could improve treatment options for themselves and others in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years, ≤75 years
• • 2. Female breast cancer patients with a pathohistologically confirmed diagnosis requiring first-time adjuvant or neoadjuvant chemotherapy and for whom the following regimens are appropriate: ① EC 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.
• • 3. Physical condition ECOG score ≤ 1;
• • 4. Weight ≥ 45kg;
• • 5. 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;
• • 6. Survival is expected to be 6 months or more;
• • 7. The subject is willing to use an appropriate method of contraception for the duration of the trial;
• • 8. Subjects agreed to follow the trial treatment protocol and visit schedule, enrolled voluntarily, and signed a written informed consent form.
• Exclusion Criteria:
• • 1. The subjects who have received radiation therapy within 4 weeks prior to randomization;
• • 2. Those who have received hematopoietic stem cell transplantation or bone marrow transplantation
• • 3. Patients who have been treated with G-CSF analogs or PEG-G-CSF analogs within 4 weeks prior to randomization;
• • 4. Subjects with a history of chronic granulocytic leukemia or myelodysplastic syndromes;
• • 5. People at high risk for ARDS;
• • 6. 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.);
• • 7. Patients who currently have or have had sickle cell anemia;
• • 8. 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);
• • 9. Those diagnosed with advanced breast cancer combined with distant metastases;
• • 10. Patients with known cerebrovascular malformations (e.g., cerebral hemangiomas), epilepsy;
• • 11. Patients with severe mental or neurological disorders;
• • 12. Patients with severe cardiovascular disease: history of myocardial infarction within 1 year prior to first administration of study drug; sick sinus syndrome, atrioventricular block II or greater, ventricular fibrillation, torsional ventricular tachycardia, sustained ventricular tachycardia; electrocardiogram indicative of abnormal clinically significant QRS wave lowering; congenital prolonged history of the QT interval; left ventricular ejection fraction \<50%; NYHA cardiac function class III or IV; poorly controlled hypertension. Poorly controlled hypertension: blood pressure \>160 mmHg systolic and/or \>100 mmHg diastolic despite antihypertensive medications; congestive heart failure; stable coronary artery disease; unstable angina pectoris;
• • 13. Liver function indexes: ALT, AST, TBIL ≥1.5 times the upper limit of normal before enrollment; Kidney function indexes: Scr ≥1.5 times the upper limit of normal;
• • 14. Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and peripheral blood Hepatitis B Virus (HBV) DNA test is greater than the normal range; Positive for Hepatitis C Virus (HCV); Positive for Human Immunodeficiency Virus (HIV);
• • 15. Those with a current active infection (and a temperature ≥38°C) or who have received systemic anti-infective therapy within 72 hours prior to chemotherapy;
• • 16. Patients with severe mouth ulcers;
• • 17. Participated in 3 or more clinical trials of a drug within the last year, or participated in any clinical trial of a drug within the last 3 months, as a subject and actually used the test drug;
• • 18. Hypersensitivity to the adjuvant or neoadjuvant chemotherapeutic agents used (e.g., docetaxel, epirubicin, carboplatin, cyclophosphamide) and to PEG-G-CSF and G-CSF analogs;
• • 19. Lithium-treated patients were required during the clinical trial;
• • 20. Alcohol-dependent individuals or those with a history of substance abuse;
• • 21. Lactating and pregnant females and those planning a pregnancy within 6 months of the last injection of the test drug in this study;
• • 22. Combined primary diseases of the cerebrovascular, hepatic, renal, endocrine, and hematologic systems of a severity judged by the investigator to be inappropriate for participation in this clinical trial;
• • 23. Other patients who, in the judgment of the investigator, are not suitable subjects for this trial.