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| Name | Class |
|---|---|
| China Pharmaceutical University | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin paclitaxel/neutrophil drug | Experimental | Isolate the patients' autologous neutriphil cells, induce and culture them with albumin paclitaxel in vitro. Then the drug will be infused intravenously into patients. The number of neutriphil cells will be more than 1.0E10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin paclitaxel/neutrophil drug | Biological | Isolate the patients' autologous neutriphil cells, induce and culture them with albumin paclitaxel in vitro. The final product for Albumin paclitaxel/neutrophil drug. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 13 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Longwei, Master | Contact | +86-02580864524 | jianglw2005@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Shaochang, MD | Jinling Hospital, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital | Recruiting | Nanjing | Jiangsu | 210002 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Jinling Hospital | Recruiting | Nanjing | Jiangsu | 210002 | China |
|
| D017437 |
| Skin and Connective Tissue Diseases |