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

NCT06496724 | Recruiting

• 1 other identifier: swzl20230906
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To evaluate the efficiency of Albumin-bound Paclitaxel/Granulocyte drug in the treatment of Recurrent/Metastatic Breast Cancer

  13 months

Study Arms (1)

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.

Biological: Albumin paclitaxel/neutrophil drug

Interventions

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.

Albumin paclitaxel/neutrophil drug

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• JIANG LONGWEI: lead
• China Pharmaceutical University: collaborator

Study Sites (2)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jia Shaochang, MD

  Jinling Hospital, China

  STUDY DIRECTOR

Central Study Contacts

Jiang Longwei, Master

CONTACT

+86-02580864524; jianglw2005@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate researcher

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: June 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2024-07

Locations

CN (2)