Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment in Patients With Late-Stage Breast Cancer

This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) to guide late-line therapy in late-stage metastatic breast cancer patients.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Circulating Tumor DNA Gene Abnormality Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

About this study

This study aims to evaluate the feasibility of plasma ctDNA mutation in guiding late-line treatment for late-stage metastatic breast cancer patients. Meanwhile, this study tries to evaluate the curative effect of ctDNA subtype-guided late-line therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control group

Drug

Physician chosen treatment

Case Group

Drug

Druggable ctDNA alterations-guided therapy

Other names: PARP inhibtior, EGFR inhibitor, CDK4/6 inhibitor, AR antagonists, anti-VEGFR, anti-FGFR, Fulvestrant, ADC drugs, PI3K inhibitor, anti-HER2 treatment, HDAC inhibitor

Primary outcomes

Disease Control Rate (DCR)

Time frame: From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment.

The total rate of CR+PR+SD after the completion of two cycles of late-line therapy.
Progression-Free Survival

Time frame: From 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 survival time between the beginning of treatment to death or the progression.

Sponsors and collaborators

Lead sponsor

Hunan Cancer Hospital

Other

Registry information

Official study title

Clinical Application of Circulating Tumor DNA (ctDNA) to Guided the Late-Line Treatment for Patients With Late-Stage Breast Cancer

Acronym: ACTDNAGLT

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2021
First posted: Jun 22, 2022
Registry last updated: Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed