drugset / Trial / NCT04941885

Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus Aromatase Inhibitor in Metastatic HER2+/HR+ Breast Cancer

NCT04941885

Phase 2 Unknown 78 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

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 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.

Timeline

Start
2021-06-25
Primary completion
2023-07-01
Completion
2025-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 50 mg Oral
Subject Inetetamab Monoclonal antibody 6 mg/kg Intravenous

Indications