Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04137653
Status:
RECRUITING
Last Update Posted:
2021-07-20
First Post:
2019-10-22
Brief Title:
Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy a Prospective RCT
Sponsor:
Shengjing Hospital
Organization:
Shengjing Hospital
Study Overview
Official Title:
Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy a Prospective Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Breast cancer has been one of the most common malignant tumors with highest morbidity and mortality that threatens womens health worldwide Among US women there were 250000 new invasive breast cancers and 40000 breast cancer deaths in 2017 In the US 124 women develop breast cancer in their lifetime and the incidence of breast cancer in women over 50 years of age has increased significantly Although the development of molecular typing and comprehensive treatments have significantly improved the prognosis of breast cancer patients the recurrence and metastasis of breast cancer is still the main cause of death in breast cancer patients
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
Paclitaxel is a natural secondary metabolite isolated and purified from the bark of Taxus chinensis It has been clinically proven to have a good anti-tumor effect However polyoxyethylene castor oilethanol is often used as a solvent for paclitaxel in clinical practice and this solvent-based paclitaxel is prone to causing severe allergic reactions even aggravating myelosuppression and neurotoxicity In addition the solvent-based paclitaxel can also influence the efficacy of other drugs by inhibiting albumin-mediated drug delivery nab-P is a novel paclitaxel that can compensate for the adverse effects of solvent-based paclitaxel and have good efficacy and safety Compared with the solvent-based 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
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
Paclitaxel is a natural secondary metabolite isolated and purified from the bark of Taxus chinensis It has been clinically proven to have a good anti-tumor effect However polyoxyethylene castor oilethanol is often used as a solvent for paclitaxel in clinical practice and this solvent-based paclitaxel is prone to causing severe allergic reactions even aggravating myelosuppression and neurotoxicity In addition the solvent-based paclitaxel can also influence the efficacy of other drugs by inhibiting albumin-mediated drug delivery nab-P is a novel paclitaxel that can compensate for the adverse effects of solvent-based paclitaxel and have good efficacy and safety Compared with the solvent-based 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None