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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Subjects with pathologically confirmed breast cancer; 2. The therapeutic drugs are anti-HER2-ADC drugs; 3. No history of other tumors; 4. Age > 18 years old; 5. Have relatively complete clinical case characteristics data.

Disqualifiers

1. Male breast cancer subjects; 2. Suffering from other malignant neoplasms; 3. Subjects with incomplete clinical case characteristics.

Trial population

Breast cancer patients treated with anti-HER2-ADC drugs

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Against HER 2-ADC Drug

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: HER2 low-expressing1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate

Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.

Time frame
1-2 years

Secondary outcomes

1

PFS

Time frame
1-2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Shenzhen New Industries Biomedical Engineering Co., Ltd.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: