Clinical Outcome and Quality of Life of Intrathecal Chemotherapy Through Ommaya Reservoir in Combination With Systematic Chemotherapy Versus Systematic Chemotherapy Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis (CONQUER)
This is a prospective, multicenter, randomized controlled, open-label investigator-initiated clinical study to evaluate the clinical efficacy and quality of life of intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy versus systemic chemotherapy alone in patients with Her-2 negative breast cancer with leptomeningeal metastasis.
• Male or female aged 18 years or above;
• Can understand the purpose of clinical trials and the benefits and risks, voluntarily participate in and sign the informed consent
• The physical status score of the Eastern Oncology Consortium (ECOG) was ≤3;
• HER2-metastatic breast cancer confirmed histologically or cytologically (HER2- is defined as either a standard immunohistochemical (IHC) test result of 0 or 1+, or an IHC test result of 2+ and a negative ISH test result);
• Failure of standard treatment, or intolerance to standard treatment;
• pial metastasis is present, which is defined as meningeal metastasis confirmed by malignant tumor cells found in cerebrospinal fluid cytology; Or clinical symptoms/signs suggest meningeal metastasis, and brain MRI suggests pia enhancement;
• The function of major organs was good, which was confirmed by the following laboratory tests during the screening period:
• Platelet count ≥80\*10\^9/L
• Hemoglobin ≥8g/L
• Neutrophil count ≥1.5\*10\^9/L
• Serum creatinine ≤1.5\*ULN
• ALT and AST≤ 3\*ULN (if liver metastases are present, ALT and AST≤5\*ULN)
• Serum total bilirubin ≤1.5\*ULN
• International Standardized ratio (INR) and Activated partial thromboplastin time (APTT) ≤1.5\*ULN
• NYHA cardiac function grade ≤II, no obvious abnormality in ECG, or no clinical significance according to the investigators;
• Voluntary compliance with the trial protocol during the study period and regular follow-up;
⁃ For all women of childbearing age, fertile men or their spouses who did not plan to have children or donate sperm during the entire trial period until 6 months after the last dose, or who voluntarily took effective contraception, the blood/urine pregnancy test results of female patients of childbearing age within 7 days before enrollment were negative.
⁃ Subjects who have recovered from non-hematological toxicity from the last treatment (CTCAE≤ class 1, except for special conditions such as alopecia) before first administration, and who the investigator determines that the corresponding AE does not pose a safety risk.