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 1.11 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 inhibitors(AI) in the treatment of metastatic HER2-positive and HR-positive breast cancer patients and to explore the possible mechanisms.
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 1.11 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 inhibitors(AI) in the treatment of metastatic HER2-positive and HR-positive breast cancer patients, and we further exploring the possible mechanisms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Each participant receives Inetetamab plus cyclophosphamide metronomic chemotherapy plus AI.
Shusen Wang
Guangzhou, Guangdong, China
RECRUITINGObjective response rate (ORR)
The proportion of best overall response of either complete or partial response.
Time frame: 1 year
Clinical benefit rate (CBR)
Response and progression will be evaluated using RECIST 1.1. Evaluation will occur every 3 months till progression or termination of the study. CBR is defined as ratio of participants who have stable disease for over 24 weeks.
Time frame: 1 year
Progression free survival (PFS)
Time from the date of treatment to the date of tumor progression.
Time frame: 1 year
Duration of response (DOR)
Time from the first assessment of the tumor as complete or partial response to the first assessment as PD (Progressive Disease) or death from any cause.
Time frame: 1 year
Overall survival (OS)
Time from the date of treatment to the date of death.
Time frame: 3 years
Number of Participants with Adverse Events
Number of participants with adverse events related to the treatment.
Time frame: 1 year
The quality of life
Using Functional Assessment of Cancer therapy -Breast (FACT-B) scale. The minimum and maximum values are 0 and 144, respectively. Higher scores mean better outcome.
Time frame: 1 year
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