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Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of HER2-positive Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:
A Phase II Single-arm Clinical Trial of Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of Patients With HER2-positive Metastatic Breast Cancer

Clinical Trial Summary

In this phase 2 single-arm clinical trial, 30 patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment of Inetetamab plus Pyrotinib plus Oral Vinorelbine. The study aimed to access the efficacy and safety of Inetetamab combined with Pyrotinib and Oral Vinorelbine in HER2-positive metastatic breast cancer patients after progression on trastuzumab.

Clinical Trial Description

Trastuzumab is an important agent for the treatment of patients with HER2-positive metastatic breast cancer. However, a considerable number of patients will develop resistance to trastuzumab treatment. Previous studies have shown that multiple mechanisms mediate trastuzumab resistance, such as abnormal extracellular domain of the HER2 receptor, HER3 mutation and activation of bypass signaling pathway. To overcome these resistance mechanisms, the combination of trastuzumab with HER2-targeting tyrosine kinase inhibitor (TKI) is an effective strategy. In this phase 2 single-arm clinical trial, 30 patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment of Inetetamab plus Pyrotinib plus Oral Vinorelbine. The study aimed to access the efficacy and safety of Inetetamab combined with Pyrotinib and Oral Vinorelbine in HER2-positive metastatic breast cancer patients after progression on trastuzumab. The primary end point is Progressive-free Survival (PFS). The secondary end points are Overall Survival (OS), Overall Response Rate (ORR), Clinical Benefit Rate (CBR) and safety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05823623
Study type Interventional
Source The First Affiliated Hospital with Nanjing Medical University
Contact Xiang Huang
Phone +8613701473675
Email lorelai@njmu.edu.cn
Status Recruiting
Phase Phase 2
Start date February 13, 2022
Completion date December 2025
View Details
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