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

NCT06492447 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-07-09

No results posted yet for this study

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.

Conditions

  • HER 2 Low-expressing Breast Cancer

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.

Sponsors & Collaborators

  • Shenzhen New Industries Biomedical Engineering Co., Ltd.

    collaborator UNKNOWN

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-04
Primary Completion
2026-01-04
Completion
2026-03-04

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06492447 on ClinicalTrials.gov