Clinical Application of Circulating Tumor DNA (ctDNA) in Patients With Late-stage Breast Cancer (ACTDNA)

Central South University

Status

Completed

Conditions

Circulating Tumor DNA

Gene Abnormality

Metastatic Breast Cancer

Treatments

Diagnostic Test: ctDNA testing

Study type

Observational

Funder types

Other

Identifiers

NCT05079074

2017YS031

Details and patient eligibility

About

This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) application in late-stage breast cancers.

Full description

This study aims to evaluate the feasibility of plasma ctDNA mutation spectrum and clonal spectrum in late-stage metastatic breast cancer patients. Meanwhile, this study tries to establish a model of ctDNA subtyping system to evaluate the molecular load of tumor, to evaluate the curative effect comprehensively and to detect the disease progression in advance. In addition, the investigators plan to explore the clonal evolution of ctDNA in patients with progressive disease (PD), and to monitor the changes of tumor heterogeneity from the molecular level, so as to provide reference for the analysis of drug sensitivity.

Enrollment

223 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Recent progression of TNBC after multiple lines of chemotherapy or of HR+ or HER2+ MBC after multiple lines of endocrine or targeted therapy;
No available recommendation for the next treatment regimen;
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
An updated, available pathological HR/HER2 status for metastasis;
According to RECIST 1.1 standard, there should be at least one measurable target lesion;
The expected survival time is > 3 months;
Those aged 18-70 years old;
Liver and kidney function and blood routine test meet the following conditions: Neutrophil > 2.0g/l, Hb > 9g / L, PLT > 100g / L; ALT and AST < 2.5ULN; TBIL < 1.5ULN; Cr < 1.0ULN
Signing informed consent;
Those willing to accept polygenic testing.

Exclusion criteria

Patients with multiple primary tumors;
Those who are unable to obtain blood samples;
Those with a history of immunodeficiency or organ transplantation;
Those with abnormal cardiac function or previous history of myocardial infarction or serious arrhythmia;
The researchers think it is not suitable to participate in this experiment.