NCT06479460

Clinical Application of ctDNA Dynamic Monitoring in Neoadjuvant Therapy for HER2-positive Breast Cancer Patients

Director, Department of Pathology, Jiangsu Provincial People's Hospital

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

1. To explore the predictive value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population; 2. To evaluate the prognostic value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population.

Detailed description

This study plans to enroll 50 HER2 positive breast cancer patients in early stage (T2-3, N0-1, M0)/local late stage (T2-3, N2-3, M0 or T4a-c, Nany, M0), collect baseline tumor tissue samples of patients, as well as peripheral blood samples of multiple nodes at baseline, during new adjuvant therapy, after new adjuvant therapy (before surgery), and after surgery, detect the mutation of tumor tissue through 1021 panel, and conduct ctDNA detection of peripheral blood samples based on personalized panel design based on tumor tissue specific mutations, to explore the efficacy prediction and prognostic predictive value of ctDNA in HER2 positive new adjuvant therapy population.

Conditions

• Breast Cancer
• Neoadjuvant
• HER2-positive Breast Cancer
• Circulating Tumor DNA

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ctDNA-MRD	This study is an observational non intervention study that only tests peripheral blood samples from different treatment nodes of the subjects, without interfering with the normal clinical diagnosis and treatment process of the patients.

Timeline

• Start date: 2024-03-08
• Primary completion: 2025-05-31
• Completion: 2026-03-31
• First posted: 2024-06-28
• Last updated: 2024-07-24

Locations

1 site across 1 country: China