Actively Recruiting

Phase 3
Age: 18Years - 70Years
FEMALE
NCT04137653

Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective RCT

Led by Shengjing Hospital · Updated on 2021-07-20

1498

Participants Needed

1

Research Sites

280 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Triple-negative breast cancer (TNBC) accounts for about 20% of clinical breast cancer. Clinical characteristics include early onset, high malignancy and heterogeneity. There is no effective drug target for TNBC, resulting in poor outcomes, high relapse rate and distant metastasis. So, further research on TNBC pathological features is particularly important. Compared with the solvent-based paclitaxel, albumin-bound paclitaxel (nab-P) demonstrates a stronger therapeutic effect. With albumin nanoparticles as a carrier, nab-P increases the concentration of extra-tumor drugs by passing through the albumin receptor (Gp60) transmembrane pathway and the secreted protein acidic and rich in cysteine (SPARC) approach that binds to the extracellular matrix of the tumor. Numerous clinical trials have found that nab-P is superior to the solvent-based paclitaxel in the treatment of breast cancer, especially in breast cancer with poor prognosis. However, the current efficacy of nab-P in the treatment of TNBC has not been fully verified. The mechanism underlying the killing effect of nab-P on TNBC breast cancer cells remains unclear yet. This trial will compare the therapeutic effect of nab-P with solvent-based paclitaxel in TNBC patients, and seek for important scientific clues, scientific evidence, and clinical data for nab-P in the treatment of TNBC.

CONDITIONS

Official Title

Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective RCT

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Breast cancer confirmed by mammography and immunohistochemical tests negative for estrogen receptor, progesterone receptor, and HER2
  • Positive axillary lymph node metastasis
  • Female aged between 18 and 70 years
  • Willingness to comply with treatment plan, volunteer for random treatment with solvent-based paclitaxel or nab-P, and provide written informed consent after understanding the study
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Presence of distant metastasis
  • History of other cancers or previous chest radiotherapy
  • Abnormal blood tests or symptoms of infection
  • Allergy to paclitaxel
  • Current or past psychotropic drug abuse or history of mental disorders
  • Abnormalities in major organs such as heart, lungs, liver, or kidneys
  • Participation in other clinical trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China, 110004

Actively Recruiting

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Research Team

X

Xi Gu, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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