MedTrace Logo

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

NCT04137653 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1498

Last updated 2021-07-20

No results posted yet for this study

Summary

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

Interventions

DRUG

nab-Paclitaxel+carboplatin

Nab-P (Abraxis BioScience, LLC., Mclrose Park, IL, USA; drug license No. H20091059), 125 mg/m2, intravenous drip for 30 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions; at the same time, carboplatin (Qilu Pharmaceutical Co., Ltd., Jinan, Shandong Province, China; drug license No. Guoji Zhunzi H20020181), AUC=2 mg•min/mL, intravenous drip for 120 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions.

DRUG

Paclitaxel+carboplatin

Paclitaxel (Yangtze River Pharmaceutical Co., Ltd., Taizhou, Jiangsu Province, China; drug license No. Guoyao Zhunzi H20053001), 125 mg/m2, intravenous drip for 30 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions; at the same time, carboplatin, AUC=2 mg•min/mL, intravenous infusion for 120 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions.

Sponsors & Collaborators

  • Shengjing Hospital

    lead OTHER

Principal Investigators

  • Caigang Liu, M.D., Ph.D. · Shengjing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2025-11-30
Completion
2026-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04137653 on ClinicalTrials.gov