A Study of Mitoxantrone Hydrochloride Liposome Injection in Advanced Recurrent or Metastatic Breast Cancer

This is an interventional treatment trial for Advanced Recurrent or Metastatic Breast Cancer Read More

Inclusion Criteria:

• Written informed consent prior to study specific screening procedures;
• ≥ 18 and ≤ 75 years of age,female;
• Advanced recurrent or Metastatic breast cancer, comfirmed by histological analysis and/or cytology analysis. Have failed for at least two chemotherapy regimen aimed to the advanced recurrent or metastatic focus;
• Adapted to receive chemotherapy;
• Women diagnosed with human epidermal growth factor receptor negative(HER2-); Women diagnosed with HER2+, and unable to be treated by Anti-HER2+ targeted therapy. HER2- is defined as 0 or 1+ staining on immunohistochemistry or FISH negative for gene amplification. HER2+ is defined as +++ staining on immunohistochemistry or FISH positive for gene amplification;
• Not suitable for endocrine theapy or tolerance to endocrine therapy;
• Have at least one measurable site of disease according to RECIST1.1 criteria;
• If chemotherapy regimens containing anthracycline-based drugs, duration from palindromia to this chemotherapy regimens is not less than 12 mounths;
• ECOG performance status of 0-2, life expectancy of more than 3 mounths;
• Cardiac function is almost normal(NYHA classification is Grade 1, LVEF≥ 50％);
• Sexually active women of childbearing potential must use a medically acceptable form of contraception;
• Adequate hepatic, renal and hematologic functions: leukocyte≥3.0×10^9/L,neutrophils≥1.5×10^9/L,platelets≥75×10^9/L, hemoglobin≥90g/L, serum bilirubin≤1.5×ULN, ALT≤2.5×ULN(5×for liver metastasis),AST≤2.5×ULN(5×for liver metastasis), creatinine clearance rate≤1.5×ULN;

Exclusion Criteria:

• Suffering from serious internal disease, including serious heart attack, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer;
• Uncontrolled brain metastases;
• Pregnant or lactating women;
• Mitoxantrone has been used before;
• Anthracycline-based drugs was used after relapse and metastasis;
• The cumulative doses of doxorubicin and epirubicin before inclusion have surpassed 360 mg/m2 and 600 mg/m2, respectively;
• Less than 4 weeks from the last chemotherapy, less than 4 weeks from the last radiotherapy, less than 2 weeks from the last endocrinotherapy; Other antineoplastic drugs need to be used in this study;
• History of anthracycline-based drug allergy;
• History of liposome drug allergy;
• Uncontrolled psychosis or uncontrolled infections disease;
• Unsuited to participate in thsi study judged by investigators;