Correlation Study of Serum HER 2 Against HER 2-ADC Drug Efficacy in HER 2 Low-expressing Breast Cancer

Breast cancer is one of the most common malignancies in women worldwide, with HER2-positive breast cancer accounting for about 15-20% of all breast cancer cases. HER2 (Human epidermal growth factor receptor 2) is a tyrosine kinase receptor that, when overexpressed, promotes the growth and spread of tumor cells. The advent of anti-HER2 therapy, particularly antibody-coupled drugs (ADCs), has resulted in significant survival benefits for HER2-positive breast cancer subjects. At present, the value of serum HER2 in the monitoring of anti-HER2-ADC drug therapy is insufficient. The purpose of this study was to investigate changes in serum HER2 expression levels in breast cancer subjects treated with anti-HER2-ADC drugs and the relationship between these changes and treatment effect. The therapeutic effect of HER2 was evaluated by continuous detection of HER2 serum, which provided a theoretical basis for the selection of clinical drug treatment.

NCT Number	NCT06492447
Lead Sponsor	Tianjin Medical University Cancer Institute and Hospital Collaborators: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Conditions	HER 2 Low-expressing Breast Cancer
Enrollment	50 participants
Start Date	2024-07-04
Primary Completion	2026-01-04 (estimated)
Study Completion	2026-03-04 (estimated)
Updated on ClinicalTrials.gov	2024-07-09