NCT03947736

Dynamic Monitoring of HER2 and ctDNA Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR

Detection of HER2 Amplification Status and Dynamic Monitoring of Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This was a prospective, single-center clinical study. The study was designed to investigate the relationship between plasma HER2 amplification or specific mutations abundance and clinical response in patients with recurrent or metastatic breast cancer.

Detailed description

Patients were divided into two groups according to ctDNA HER2 amplification status by dPCR method. Group A consisted of patients with positive HER2 amplification at the time of enrollment. Plasma HER2 amplification status was measured by dPCR during dynamic monitoring. GroupB consists of patients with negative HER2 amplification when enrolled. Plasma samples were collected before treatment and breast cancer hotspot mutations were detected with NGS, According to the NGS test results, patient's specific mutations were analyzed and selected, which and plasma HER2 amplification status were measured by dPCR during dynamic monitoring. The study was designed to investigate the relationship between plasma HER2 amplification or specific mutations abundance and imaging assessment in patients with recurrent or metastatic breast cancer. And also to investigate the proportion of predicting in advance the treatment efficacy of recurrent or metastatic breast cancer by plasma HER2 ctDNA, as well as the median time difference between predicted clinical efficacy by changes in abundance of plasma HER2 amplification specific mutations and medical imaging evaluation in patients. The study only focus on ctDNA detection and does not involve any interventions.

Conditions

• Recurrent or Metastatic Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	cfDNA was detected by dPCR	Without drug intervention, the patient's peripheral blood was collected and cfDNA was extracted for digital PCR detection.

Timeline

• Start date: 2018-09-17
• Primary completion: 2020-12-31
• Completion: 2021-06-01
• First posted: 2019-05-13
• Last updated: 2019-05-14

Locations

1 site across 1 country: China