This randomized, double-blind, placebo-controlled pilot study aims to evaluate the efficacy and safety of GcMAF in reducing nagalase levels and improving clinical outcomes in female patients with metastatic breast cancer over six months. Sixty patients will be randomized into two groups receiving either weekly GcMAF or placebo injections. The primary endpoint is the change in serum nagalase levels from baseline to six months. Secondary endpoints include clinical status, quality of life, adverse effects, and markers of inflammation and immune activity. Tumor response will be assessed using RECIST criteria, and quality of life will be measured with the EORTC QLQ-C30 questionnaire. Immune and inflammation markers will be evaluated using flow cytometry and ELISA. Adverse events will be monitored and categorized according to severity. Inclusion criteria include confirmed metastatic breast cancer, completion of one line of systemic therapy, adequate organ function, and elevated serum nagalase levels. The study will involve baseline measurements, monthly assessments, and final evaluations to compare changes in nagalase levels and other clinical outcomes between the GcMAF and placebo groups.
Histologically or cytologically confirmed metastatic breast cancer.
Patients must have completed at least one line of systemic therapy (e.g., chemotherapy, hormone therapy, targeted therapy) for metastatic breast cancer.
Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, and hemoglobin ≥ 9 g/dL.
Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver metastases).
Known hypersensitivity to any component of the study drug or its formulation.
Parallel
GcMAF injections (100 ng)
Biological/VaccineThe GcMAF 100 ng (Gc protein macrophage-activating factor) will be injected subcutaneously.
placebo
Other interventionthe placebo solution will be injected subcutaneously 100 ng.
Change in Serum Nagalase Levels
Change in RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
MRI changes in cancer volume
Tumor response
one of 4 categories Complete Response (CR), Partial Response (PR), Stable Disease (SD),Progressive Disease (PD)
Eastern Cooperative Oncology Group (ECOG) performance status change
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S.LAB (SOLOWAYS)
Lead sponsor
Center of New Medical Technologies
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
