Ignite Creation Date:
2024-05-06 @ 4:19 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04941885
Status:
RECRUITING
Last Update Posted:
2021-07-02
First Post:
2021-06-25
Brief Title:
Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus Aromatase Inhibitor in Metastatic HER2HR Breast Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Phase II Single-arm Clinical Trial of the Efficacy and Tolerability of Inetetamab Combined With Cyclophosphamide Metronomic Chemotherapy and Aromatase Inhibitor in Metastatic HER2HR Breast Cancer
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:
Increase
Brief Summary:
Antibody-dependent cell-mediated cytotoxicity ADCC is one of the important mechanisms for suppressing tumors of Trastuzumab Pre-clinical data suggest that the ADCC effect of Inetetamab an anti-HER2 monoclonal antibody with a modified Fc segment is 111 times that of trastuzumab Previous studies indicated that enhanced ADCC effects can be transformed into clinical benefits Immune induction through cyclophosphamide metronomic chemotherapy may further enhance the ADCC effect of anti-HER2 monoclonal antibodies Therefore we conducted this study to explore the efficacy and the safety of Inetetamab combined with cyclophosphamide metronomic chemotherapy and aromatase inhibitorsAI in the treatment of metastatic HER2-positive and HR-positive breast cancer patients and to explore the possible mechanisms
Detailed Description:
Trastuzumab is a humanized monoclonal antibody and antibody-dependent cell-mediated cytotoxicity ADCC is one of its important mechanisms for suppressing tumors Pre-clinical data suggest that the ADCC effect of Inetetamab an anti-HER2 monoclonal antibody with a modified Fc segment is 111 times that of trastuzumab Previous studies indicated that enhanced ADCC effects can be transformed into clinical benefits but the absolute benefits are still unsatisfactory Further improvement of ADCC effects and monoclonal antibody-induced immune responses may improve the clinical benefits Immune induction through cyclophosphamide metronomic chemotherapy may further enhance the ADCC effect of anti-HER2 monoclonal antibodies According to previous clinical studies for HR-positive and HER2-positive metastatic breast cancer patients metronomic chemotherapy combined with endocrine therapy and anti-HER2 targeted therapy may be one of the treatment options Therefore we conducted this study to explore the efficacy and the safety of Inetetamab combined with cyclophosphamide metronomic chemotherapy and aromatase inhibitorsAI in the treatment of metastatic HER2-positive and HR-positive breast cancer patients and we further exploring the possible mechanisms
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