Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496724
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
A Clinical Study of Albumin-bound PaclitaxelGranulocyte-based Therapy for RecurrentMetastatic Breast Cancer
Sponsor:
JIANG LONGWEI
Organization:
Jinling Hospital China
Study Overview
Official Title:
A Clinical Study of Albumin-bound PaclitaxelGranulocyte-based Therapy for RecurrentMetastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if Albumin-bound PaclitaxelGranulocyte drug can treat patients with recurrentmetastatic breast cancer The main questions it aims to answer are
To verify the safety of Albumin-bound PaclitaxelGranulocyte drug in patients with recurrentmetastatic breast cancer
To evaluate the efficacy of Albumin-bound PaclitaxelGranulocyte drug in patients with recurrentmetastatic breast cancer
To detect the pharmacokinetic behavior of Albumin-bound PaclitaxelGranulocyte drug in patients with recurrentmetastatic breast cancer
To verify the safety of Albumin-bound PaclitaxelGranulocyte drug in patients with recurrentmetastatic breast cancer
To evaluate the efficacy of Albumin-bound PaclitaxelGranulocyte drug in patients with recurrentmetastatic breast cancer
To detect the pharmacokinetic behavior of Albumin-bound PaclitaxelGranulocyte drug in patients with recurrentmetastatic breast cancer
Detailed Description:
In this open single-armed study selected patients with recurrentmetastatic breast cancer confirmed by Histopathology will be received Albumin-bound PaclitaxelGranulocyte-based therapy The granulocyte will be separated by blood cell separator and will be cultured in the GMP laboratory to make Albumin-bound PaclitaxelGranulocyte drug Then the drug will be infused intravenous into patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None