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

Completed

• Conditions: Metastatic Breast Cancer; Gene Abnormality; Circulating Tumor DNA
• Interventions: Diagnostic Test: ctDNA testing

• Registration Number: NCT05079074
• Lead Sponsor: Hunan Cancer Hospital

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.

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2019-06-30
• Study Completion: 2021-06-30
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-02
• Study First Posted: 2021-10-15
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 223

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with late-stage metastatic breast cancers.	ctDNA testing	This cohort included patients with late-stage metastatic breast cancers and their disease progressed after at least two-line treatment.

Primary Outcome Measures

Name	Time	Method
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.