Treatment for recurrent or metastatic breast cancer using a new drug combination
A Clinical Study of Albumin-bound Paclitaxel/Granulocyte-based Therapy for Recurrent/Metastatic Breast Cancer
This study is testing a new combination of drugs to see if it can help people with recurrent or metastatic breast cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Jinling Hospital, China Academic / other |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT06496724 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of a novel therapy combining Albumin-bound Paclitaxel and granulocytes in patients with recurrent or metastatic breast cancer. The study involves an open-label, single-arm design where eligible patients will receive the treatment after their granulocytes are cultured in a GMP laboratory. The trial will also assess the pharmacokinetics of the drug to understand how it behaves in the body. Participants will be closely monitored for safety and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and older with recurrent or metastatic breast cancer who have previously undergone standard first-line treatments.
Not a fit: Patients who have received other anti-tumor treatments within the last four weeks or have a history of allergies to the study drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent or metastatic breast cancer.
How similar studies have performed: While this approach is innovative, similar studies using granulocyte-based therapies have shown promise in other cancer treatments, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nanjing, Jiangsu and 1 other locations
- Jinling Hospital — Nanjing, Jiangsu, China (Recruiting)
- Jinling Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Jiang Longwei, Master
- Email: jianglw2005@163.com
- Phone: +86-02580864524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.