Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 70 Women only

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.

More Breast Cancer trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 70 Years
SexWomen only
Enrollment1498 (estimated)
SponsorShengjing Hospital
Academic / other
Locations1 site (Shenyang, Liaoning)
StatusRecruiting
StartedJuly 19, 2021
Main results expectedNovember 30, 2025
Study endsNovember 30, 2026
Registry record updatedJuly 20, 2021
Trial IDNCT04137653 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.