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Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective RCT
Sponsor: Shengjing Hospital
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.
Official title: Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective Randomized Controlled Clinical Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
1498
Start Date
2021-07-19
Completion Date
2026-11-30
Last Updated
2021-07-20
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China