Using albumin-bound paclitaxel to treat triple-negative breast cancer before surgery
Official title: Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective Randomized Controlled Clinical Trial
Run by Shengjing Hospital · NCT04137653 · Data updated 2026-11-12
This study is testing if a new type of chemotherapy using albumin-bound paclitaxel can help women with triple-negative breast cancer before surgery, compared to the standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 1498 (estimated) |
| Sponsor | Shengjing Hospital Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Status | Recruiting |
| Started | July 19, 2021 |
| Main results expected | November 30, 2025 |
| Study ends | November 30, 2026 |
| Registry record updated | July 20, 2021 |
| Trial ID | NCT04137653 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18-70 with confirmed triple-negative breast cancer and positive axillary lymph node metastasis.
✕Probably not a fit
Patients with distant metastasis, other cancers, or severe allergies to paclitaxel may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of albumin-bound paclitaxel (nab-P) as a neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). The study compares nab-P combined with carboplatin to traditional solvent-based paclitaxel with carboplatin. It aims to evaluate the therapeutic benefits of nab-P, which utilizes albumin nanoparticles to enhance drug delivery to tumors, potentially improving patient outcomes. The trial includes women aged 18-70 with confirmed TNBC and positive axillary lymph node metastasis.
Why it matters
Potential benefit: If successful, this treatment could lead to improved outcomes and reduced recurrence rates for patients with triple-negative breast cancer.
How similar studies have gone: Previous studies have shown that albumin-bound paclitaxel is superior to solvent-based paclitaxel in treating breast cancer, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * breast cancer is confirmed by the mammography, and the immunohistochemical results of cancer tissues are negative for estrogen receptor, progesterone receptor and anti-human epidermal growth factor receptor 2; * positive for axillary lymph node metastasis; * 18-70 years of age, female; * patients have good compliance with the planned treatment, who are volunteer to participate in the study, are willing to be treated with solvent-based paclitaxel or nab-P at random, and provide written informed consent with the premise of fully understanding the study protocol. Exclusion Criteria: * pregnant and lactating women; * distant metastasis; * patients with a history of other cancers or who have received radiotherapy on the chest; * abnormalities in blood tests or presence of other symptoms of infection; * allergy to paclitaxel; * patients who have psychotropic drug abuse until now or those with a history of mental disorders; * abnormalities in important organs such as the heart, lung, liver and kidney; * patients who have participated in other clinical trials.
Where it's running
-
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China Recruiting
Study contacts
- Principal investigator: Caigang Liu, M.D., Ph.D. — Shengjing Hospital
- Study coordinator: Xi Gu, M.D.
- Email: jadegx@163.com
- Phone: +86 18940255116
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.