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

NCT06492447 | Not Yet Recruiting

• 1 other identifier: HR-BLTN-016
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

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.

  1-2 years

Secondary Outcomes (1)

• PFS

  1-2 years

Study Arms (1)

HER2 low-expressing

Drug: Against HER 2-ADC Drug

Interventions

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.

HER2 low-expressing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients treated with anti-HER2-ADC drugs

You may qualify if:

• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Shenzhen New Industries Biomedical Engineering Co., Ltd.: collaborator

Central Study Contacts

Yehui Shi, PhD

CONTACT

+8618622221183; shiyehui@tjmuch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 9, 2024
• Study Start: July 4, 2024
• Primary Completion: January 4, 2026
• Study Completion: March 4, 2026
• Last Updated: July 9, 2024

Record last verified: 2024-07