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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2021-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Metastatic Breast Cancer Circulating Tumor DNA Gene Abnormality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with late-stage metastatic breast cancers.

This cohort included patients with late-stage metastatic breast cancers and their disease progressed after at least two-line treatment.

ctDNA testing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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ctDNA testing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No