The goal of this clinical trial is to learn if Albumin-bound Paclitaxel/Granulocyte drug can treat patients with recurrent/metastatic breast cancer. The main questions it aims to answer are:
To verify the safety of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.
To evaluate the efficacy of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.
To detect the pharmacokinetic behavior of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.
Female, aged ≥ 18 years old; Obtain an informed consent form voluntarily signed by the patient themselves; Recurrent/metastatic advanced breast cancer patients (refer to TNM standard); Patients who have received standard first-line treatments and expected survival time ≥ 3 months; EOCG score ≤ 2 and KPS≥ 70 points; Liver, kidney and bone marrow functions are basically normal; Patients of childbearing age need to take appropriate protective measures before enrollment and after treatment 3 months.
Individuals who have received other anti-tumor treatment within 4 weeks prior the enrollment; Patients with history of allergy to paclitaxel, albumin naproxen, ibuprofen, trimethoprim and ampicillin; Positive blood pregnancy test; Patients who required anti coagulant therapy; Patients with active infectious diseases or a history of bone marrow or organ transplantation
Single group
Albumin paclitaxel/neutrophil drug
Biological/VaccineIsolate the patients' autologous neutriphil cells, induce and culture them with albumin paclitaxel in vitro. The final product for Albumin paclitaxel/neutrophil drug.
To verity the safety of Albumin-bound Paclitaxel/Granulocyte in the treatment of Recurrent/Metastatic Breast Cancer
The adverse events and severe adverse events will be evaluated.
To evaluate the efficiency of Albumin-bound Paclitaxel/Granulocyte drug in the treatment of Recurrent/Metastatic Breast Cancer
The objective clinical response will be evaluated.
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JIANG LONGWEI
Lead sponsor
Jinling Hospital, China
Sponsor institution
China Pharmaceutical University
Collaborator
