Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481553
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-25
Brief Title:
RWS of Paclitaxel Liposome Combined With Anti-HER-2 Monoclonal Antibody
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Real-world Study of the Efficacy and Safety of Paclitaxel Liposome Combined With Anti-HER-2 Monoclonal Antibody as First-line Salvage Treatment of HER-2 Positive Advanced Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
This is a retrospective single-arm real-world study based on the National Anticancer Drug Clinical Application Monitoring Network databaseThe aim of this study is to evaluate the efficacy and safety of paclitaxel liposome combined with anti-HER-2 monoclonal antibody as first-line salvage treatment for HER-2 positive advanced breast cancer It seeks to understand the application patterns efficacy and safety of paclitaxel liposome combined with anti-HER-2 monoclonal antibody in real-world settings providing patients with safer treatment options
Detailed Description:
The National Anticancer Therapy Data Surveillance System NATDSS is the largest oncology diagnosis and treatment database in China to date covering patient data from over 1400 oncology hospitals and integrated hospitals It has collected data from approximately 15 million cancer patients since 2013 including mortality information obtained from the CDC death registration database
Paclitaxel liposome was introduced to the market in 2004 as a formulation of paclitaxel It utilizes nanotechnology to encapsulate the poorly water-soluble paclitaxel within a lipid bilayer of liposomes solving the issue of paclitaxelamp low solubility in water Paclitaxel liposome no longer employs polyoxyethylated castor oil as a solvent While ensuring efficacy it reduces the risk of associated adverse drug reactions such as severe allergic reactions thereby enhancing the tolerance of cancer patients
Although paclitaxel liposome is widely used in HER-2 positive advanced breast cancer there is currently no research on the efficacy and safety of combining paclitaxel liposome with anti-HER-2 monoclonal antibodies as first-line salvage treatment of HER-2 positive advanced breast cancer
This study aims to conduct a real-world study on the efficacy and safety of combining paclitaxel liposome with anti-HER-2 monoclonal antibodies as first-line salvage treatment of HER-2 positive advanced breast cancer based on the NATDSS
Paclitaxel liposome was introduced to the market in 2004 as a formulation of paclitaxel It utilizes nanotechnology to encapsulate the poorly water-soluble paclitaxel within a lipid bilayer of liposomes solving the issue of paclitaxelamp low solubility in water Paclitaxel liposome no longer employs polyoxyethylated castor oil as a solvent While ensuring efficacy it reduces the risk of associated adverse drug reactions such as severe allergic reactions thereby enhancing the tolerance of cancer patients
Although paclitaxel liposome is widely used in HER-2 positive advanced breast cancer there is currently no research on the efficacy and safety of combining paclitaxel liposome with anti-HER-2 monoclonal antibodies as first-line salvage treatment of HER-2 positive advanced breast cancer
This study aims to conduct a real-world study on the efficacy and safety of combining paclitaxel liposome with anti-HER-2 monoclonal antibodies as first-line salvage treatment of HER-2 positive advanced breast cancer based on the NATDSS
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?:
False
Is an FDA AA801 Violation?:
None