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Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy

Advanced Breast Cancer Clinical Trial

Official title:
Trastuzumab Emtansine (T-DM1) Treatment in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy: a Multicenter, Single-arm, Phase II Study

Clinical Trial Summary

The goal of this clinical trial is to learn about the efficacy and safety of trastuzumab emtansine (T-DM1) in the treatment of patients with advanced HER2-positive breast cancer after TKIs or HP therapy. The main questions it aims to answer are: - The objective response rate of patients receiving T-DM1 therapy with advanced HER2-positive breast cancer after TKIs or HP therapy. - The adverse events and prognosis of patients with advanced HER2-positive breast cancer who receive the T-DM1 therapy. - Changes of anti-tumor immunity during T-DM1 therapy in patients with advanced HER2-positive breast cancer. Participants will receive T-DM1 treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06125834
Study type Interventional
Source The First Affiliated Hospital with Nanjing Medical University
Contact Wenbin Zhou, Ph.D
Phone +86 13814162016
Email zhouwenbin@njmu.edu.cn
Status Recruiting
Phase Phase 2
Start date June 1, 2023
Completion date May 31, 2026
View Details
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