To hear about similar clinical trials, please enter your email below
Trial Title:
A Clinical Study of Albumin-bound Paclitaxel/Granulocyte-based Therapy for Recurrent/Metastatic Breast Cancer
NCT ID:
NCT06496724
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Albumin paclitaxel/neutrophil drug
Description:
Isolate the patients' autologous neutriphil cells, induce and culture them with albumin
paclitaxel in vitro. The final product for Albumin paclitaxel/neutrophil drug.
Arm group label:
Albumin paclitaxel/neutrophil drug
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jinling Hospital
Address:
City:
Nanjing
Zip:
210002
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiang Longwei, Master
Phone:
+86-80864524
Email:
jianglw2005@163.com
Facility:
Name:
Jinling Hospital
Address:
City:
Nanjing
Zip:
210002
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiang Longwei, Master
Phone:
+862580864524
Email:
jianglw2005@163.com
Contact backup:
Last name:
JIA SHAOCHANG, MD
Phone:
+86-13905169358
Email:
jiashaochang@sina.com
Investigator:
Last name:
ZHANG CAN, PhD
Email:
Sub-Investigator
Investigator:
Last name:
JIA SHAOCHANG, MD
Email:
Sub-Investigator
Investigator:
Last name:
JU CAOYUN, PhD
Email:
Sub-Investigator
Investigator:
Last name:
YAO LU, Master
Email:
Sub-Investigator
Start date:
June 1, 2024
Completion date:
July 1, 2025
Lead sponsor:
Agency:
JIANG LONGWEI
Agency class:
Other
Collaborator:
Agency:
China Pharmaceutial University
Agency class:
Other
Source:
Jinling Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06496724
