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NCT06492447

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2024-07-04

Completion Date

2026-03-04

Last Updated

2024-07-09

Healthy Volunteers

No

Interventions

DRUG

Against HER 2-ADC Drug

Breast cancer subjects receiving anti-HER2-ADC drugs were treated with a 3-week treatment cycle lasting 6 cycles. Serum of patients before and after treatment was collected, and the changes of serum HER2 level before chemotherapy and after 2, 4 and 6 cycles of chemotherapy were dynamically monitored, and the relationship between HER2 level and the therapeutic effect of different targeted drugs was analyzed.