Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539559
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Efficacy and Resistant Mechanism of Eribulin and Bevacizumab for Advanced HER2 Negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy Adverse Events and Resistant Mechanism of Eribulin Combined With or Without Bevacizumab for Advanced HER2 Negative Breast Cancer Patients an Open-label Randomized Multi-center Phaseâ…¡ Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective multicenter phase II randomized clinical trial It is planned to enroll 60 patients with advanced HER2 negative breast cancer who will be randomly assigned to the experimental group and the control group in a 11 ratio The participants will receive either eribulin combined with bevacizumab or eribulin monotherapy Every treatment cycle will last for 21 days with weekly monitoring of blood routine blood biochemistry and other indicators Imaging examinations will be conducted every two cycles and the efficacy will be evaluated according to RECIST 11 standard The life quality questionnaire is arranged at baseline and every 3 months after enrollment and the long-time survival will be followed every 3 months after treatment The primary endpoint is progression-free survival PFS the secondary endpoints are objective response rate ORR clinical benefit rate CBR and overall survival OS The investigators will also focus on the treatment-related adverse events TRAE and quality of life QoL assessment
At the same time this study also aims to explore the resistant mechanisms of anti-angiogenic drugs The investigators plan to collect peripheral venous blood samples at 3 time points baseline during treatment and end of treatment All the dynamic samples will be used for transcriptome sequencing to obtain the gene sets And based on the optimal therapeutic efficacy all the participants will be divided into response group and non-response group GO and KEGG enrichment analysis will be subsequently performed between different therapeutic efficacy groups to draw gene interaction networks identify key action nodes and explain the mechanism of anti-angiogenic drug resistance
At the same time this study also aims to explore the resistant mechanisms of anti-angiogenic drugs The investigators plan to collect peripheral venous blood samples at 3 time points baseline during treatment and end of treatment All the dynamic samples will be used for transcriptome sequencing to obtain the gene sets And based on the optimal therapeutic efficacy all the participants will be divided into response group and non-response group GO and KEGG enrichment analysis will be subsequently performed between different therapeutic efficacy groups to draw gene interaction networks identify key action nodes and explain the mechanism of anti-angiogenic drug resistance
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None