Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF

Study Stage: Phase II/III Study Population Female patients with breast cancer will be enrolled to receive at least 4 cycles of TC chemotherapy, that is: Docetaxel 75 mg/m2 and Cyclophosphamide 600 mg/m2.

Study Design: A multi-center, randomized, open-label, active-controlled phase II/III clinical trial

Inclusion criteria

• 18～70 years old female(including threshold)
• Diagnosed with breast cancer .
• Weight≥45kg.
• Patients planned to receive TC chemotherapy.
• ECOG ≤ 1
• Estimated survival time ≥ 3 months, and could received at least 4 cycles chemotherapy treatment.
• Have suitable organs and hematopoietic function
• ECG examination is normal or abnormal has no clinical significance.
• B-ultrasound examination of abdomen showed no obvious abnormality of spleen.
• Willing to sign the informed consent form and able to comply with protocol requirements.
• Non-menopausal or non-surgically sterilized female subjects, the blood pregnancy test results must be negative at the time of screening, and within at least 3 months from the signing of the informed consent form to the end of the last administration, consent to abstinence or the use of effective contraceptive methods.

-

Exclusion criteria

• History of other malignant tumors (skin basal cell carcinoma, skin squamous cell carcinoma and / or carcinoma in situ after radical resection can be included in the group after being cured for more than 5 years)
• Primary hematological diseases, including but not limited to myelodysplastic syndrome, aplastic anemia, sickle cell anemia and other hematological diseases that affect bone marrow hematopoiesis.
• With known central nervous system metastasis or suspected central nervous system metastasis based on clinical manifestations.
• With previous history of bone marrow transplantation and / or stem cell transplantation.
• Currently uncontrolled infections or have received systematic anti-infective therapy within 72 hours before randomization.
• Serious chronic diseases of important organs such as kidney and liver.
• Severe heart disease, including but not limited to:history of congestive heart failure (New York College of Cardiology [NYHA] II or higher heart disease)Angina pectoris that needs to be treated with anti-angina pectoris drugsUncontrollable hypertension (systolic blood pressure ≥ 180 mmHg and / or diastolic blood pressure ≥ 100 mmHg)Arrhythmias requiring drug treatment
• Severe diabetes (such as fundus disease or diabetic foot), or blood sugar is still not well controlled after active treatment.
• Surgery within 2 weeks before chemotherapy or radiotherapy within 4 weeks (except for patients whose physical condition has recovered and can accept the relevant procedures of this study, as determined by the researchers)
• Adverse reactions from previous treatments failed to recover to CTCAE v5.0 score ≤ 1 (except for alopecia and other toxic reactions that researchers believe do not affect the safety of this chemotherapy)
• According to the researchers, there are serious risks to the safety of patients or concomitant diseases that affect the completion of the study.
• Participated in clinical trials of any other drugs within 4 weeks.
• Received the same efficacy drugs(such as PEG-rhG-CSF or rhG-CSF, etc.) are still in 5 half-lives or within 28 days (whichever is shorter).
• With allergic disease or allergic constitution, and who have previously been allergic to any drug or its components in this trial.
• Active hepatitis B (HBsAg positive and HBV-DNA copy number greater than the normal limit) and / or active hepatitis C (hepatitis C virus antibody positive and HCV-RNA copy number greater than the normal limit) and / or human immunodeficiency virus antibody positive and / or Treponema pallidum antibody.
• Drug abuse. history or drug abusers
• Pregnant or lactating women
• Who have been judged by the researchers to be unsuitable for selection or who are not suitable for other reasons