Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492447
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-02
Brief Title:
Correlation Study of Serum HER 2 Against HER 2-ADC Drug Efficacy in HER 2 Low-expressing Breast Cancer
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
Correlation Study of Serum HER 2 Against HER 2-ADC Drug Efficacy in HER 2 Low-expressing Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
Breast cancer is one of the most common malignancies in women worldwide with HER2-positive breast cancer accounting for about 15-20 of all breast cancer cases HER2 Human epidermal growth factor receptor 2 is a tyrosine kinase receptor that when overexpressed promotes the growth and spread of tumor cells The advent of anti-HER2 therapy particularly antibody-coupled drugs ADCs has resulted in significant survival benefits for HER2-positive breast cancer subjects
At present the value of serum HER2 in the monitoring of anti-HER2-ADC drug therapy is insufficient The purpose of this study was to investigate changes in serum HER2 expression levels in breast cancer subjects treated with anti-HER2-ADC drugs and the relationship between these changes and treatment effect The therapeutic effect of HER2 was evaluated by continuous detection of HER2 serum which provided a theoretical basis for the selection of clinical drug treatment
At present the value of serum HER2 in the monitoring of anti-HER2-ADC drug therapy is insufficient The purpose of this study was to investigate changes in serum HER2 expression levels in breast cancer subjects treated with anti-HER2-ADC drugs and the relationship between these changes and treatment effect The therapeutic effect of HER2 was evaluated by continuous detection of HER2 serum which provided a theoretical basis for the selection of clinical drug treatment
Detailed Description:
ADC drugs are a new type of targeted therapy ADC drugs are composed of monoclonal antibodies linkers and drug carriers which bind to the target antigen on the surface of tumor cells through antibodies endocytosisinternalization to form early endosomes in cells and then mature into late endosomes and fuse with lysosomes ADC drugs break apart in the lysosome and release the drug carrier eventually leading to apoptosis or death while minimizing damage to normal cells However not all subjects with HER2-positive breast cancer respond well to ADC drugs and resistance may develop during treatment Therefore effective biomarkers are needed to monitor treatment effects and guide individualized treatment Serum HER2 refers to the HER2 protein fragment present in the subjects serum Serum HER2 levels may be more readily available than HER2 expression in tumor tissue and can be sampled multiple times during treatment allowing real-time monitoring of disease progression and drug efficacy If monitoring of serum HER2 levels accurately reflects tumor sensitivity to ADC drugs it could be a valuable therapeutic monitoring tool
In view of the excellent efficacy of ADC drugs in HER2-positive and low-expression breast cancer patients this study intends to judge the therapeutic efficacy of breast cancer patients treated by anti-HER2-ADC drugs such as T-DXd through continuous detection of their serum HER2 providing a theoretical basis for the selection of clinical drug therapy
In view of the excellent efficacy of ADC drugs in HER2-positive and low-expression breast cancer patients this study intends to judge the therapeutic efficacy of breast cancer patients treated by anti-HER2-ADC drugs such as T-DXd through continuous detection of their serum HER2 providing a theoretical basis for the selection of clinical drug therapy
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