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Efficacy and Safety of Pyrotinib Maleate Combined With ARX788 Neoadjuvant Treatment in Breast Cancer Patients

Breast Neoplasms Clinical Trial

Official title:
Efficacy and Safety of Pyrotinib Maleate Combined With ARX788 Neoadjuvant Treatment in Stage II-III HER2-positive Breast Cancer Patients Who Have Poor Outcomes After Treatment With Trastuzumab and Pertuzumab

Clinical Trial Summary

Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788) is an antibody-conjugated drug. Results from the phase I safety, tolerability and pharmacokinetic trial of ARX788 single drug in Chinese patients with advanced HER2 breast cancer indicated a good safety of the test drug, and responses to anti-tumor therapy were observed in the target dose group. Phase II clinical trial is being carried out gradually. This trial is designed to observe the effectiveness and safety of pyrotinib maleate combined with ARX788 neoadjuvant treatment in stage II-III HER2-positive breast cancer patients experiencing a poor efficacy of trastuzumab and pertuzumab.

Clinical Trial Description

This study adopts a single-arm, multi-center, open design. As per the initial plan, 30 stage II-III human epidermal growth factor receptor 2 (HER2)-positive breast cancer patients who have received neoadjuvant therapy containing trastuzumab and pertuzumab and have been assessed as stable disease (SD) during the neoadjuvant treatment (an increase of 0-20%), disease progression (PD), inoperable or failing to meet the breast-conserving requirements will be enrolled to receive pyrotinib combined with Next-generation Site-specific HER2-targeting Antibody-drug Conjugate (ARX788) neoadjuvant therapy. The main purpose of the study is to observe the efficacy and safety of pyrotinib combined with ARX788 neoadjuvant treatment in stage II-III HER2-positive breast cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04983121
Study type Interventional
Source Shengjing Hospital
Contact Nan Niu, MD
Phone 8618940256668
Email niunannancy@163.com
Status Recruiting
Phase Phase 2
Start date August 1, 2021
Completion date August 15, 2027
View Details
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