Actively Recruiting
A Clinical Study of Albumin-bound Paclitaxel/Granulocyte-based Therapy for Recurrent/Metastatic Breast Cancer
Led by JIANG LONGWEI · Updated on 2025-02-12
1
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
J
JIANG LONGWEI
Lead Sponsor
C
China Pharmaceutical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating Albumin-bound Paclitaxel combined with granulocyte-based therapy for patients with recurrent or metastatic breast cancer. This clinical trial aims to assess the safety, effectiveness, and how the drug behaves in the body of patients who have advanced breast cancer that has returned or spread. The study focuses on patients who have already undergone standard first-line treatments and have a reasonable life expectancy. Selected female patients aged 18 and older will have their own neutrophil cells collected and cultured with Albumin-bound Paclitaxel in a specialized laboratory. This drug product, containing more than 10 billion neutrophil cells, will be infused intravenously. This is an open, single-arm study where all participants receive the investigational therapy. During the 13-month study period, participants will be closely monitored for safety and treatment response. Researchers will evaluate liver, kidney, and bone marrow function, measure treatment efficacy, and track side effects. Patients must agree to use birth control if of childbearing age. The study includes regular assessments to follow the safety and effects of the treatment throughout the trial.
CONDITIONS
Brief Title
A Clinical Study of Albumin-bound Paclitaxel/Granulocyte-based Therapy for Recurrent/Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 18 years or older
- Signed informed consent voluntarily
- Diagnosed with recurrent or metastatic advanced breast cancer as per TNM standard
- Have received standard first-line treatments
- Expected survival time of 3 months or longer
- ECOG score of 2 or less and KPS score of 70 or higher
- Basic normal liver, kidney, and bone marrow functions
- Childbearing age patients must use appropriate birth control before enrollment and for 3 months after treatment
You will not qualify if you...
- Received other anti-tumor treatments within 4 weeks before enrollment
- History of allergy to paclitaxel, albumin naproxen, ibuprofen, trimethoprim, or ampicillin
- Positive pregnancy test
- Require anticoagulant therapy
- Have active infectious diseases or history of bone marrow or organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 13 months
Participants receive Albumin-bound Paclitaxel/Granulocyte therapy involving isolation and intravenous infusion of their own neutrophil cells cultured with albumin paclitaxel.
Trial Site Locations
Total: 2 locations
1
Jinling Hospital
Nanjing, Jiangsu, China, 210002
Actively Recruiting
2
Jinling Hospital
Nanjing, Jiangsu, China, 210002
Actively Recruiting
Research Team
J
Jiang Longwei, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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