A Clinical Study of Albumin-bound Paclitaxel/Granulocyte-based Therapy for Recurrent/Metastatic Breast Cancer

A Clinical Study of Albumin-bound Paclitaxel/Granulocyte-based Therapy for Recurrent/Metastatic Breast Cancer

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.

In this open, single-armed study, selected patients with recurrent/metastatic breast cancer confirmed by Histopathology will be received Albumin-bound Paclitaxel/Granulocyte-based therapy. The granulocyte will be separated by blood cell separator, and will be cultured in the GMP laboratory to make Albumin-bound Paclitaxel/Granulocyte drug. Then the drug will be infused intravenous into patients.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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