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

Conditions

Circulating Tumor DNA, Gene Abnormality, Metastatic Breast Cancer

Brief summary

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

Detailed 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.

M. Arai, Alaa Khalilaa, Ahmed Elkhanany

Cancer Research2026-04-03

10.1158/1538-7445.am2026-7849

Circulating tumor DNA profile and its clinical significance in patients with hormone receptor-positive and HER2-negative mBC

Yu Tang, Jing Li, Binliang Liu, Jialu Ran, Zhe-Yu Hu et al. (6 authors)

Frontiers in Endocrinology2022-11-285 citations

10.3389/fendo.2022.1075830

The circulating tumor DNA (ctDNA) alteration level predicts therapeutic response in metastatic breast cancer: Novel prognostic indexes based on ctDNA.

Liu B, Hu Z, Ran J, Xie N, Tian C, Tang Y, Ouyang Q.

2022-07-1926 citations

10.1016/j.breast.2022.07.010

Subtyping of metastatic breast cancer based on plasma circulating tumor DNA alterations: An observational, multicentre platform study.

Hu ZY, Tang Y, Liu L, Xie N, Tian C, Liu B, Zou L, Zhou W, Wang Y, Xia X, Ouyang Q.

2022-07-186 citations

10.1016/j.eclinm.2022.101567

Interventions

DIAGNOSTIC_TESTctDNA testing

ctDNA testing was performed for late-stage metastatic breast cancer patients to trace their ctDNA abnormality.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
ctDNA change index	From the date of recruitment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.	The dynamic change of the frequency spectrum of ctDNA mutation in plasma.

Outcome results

None listed