Clinical trial · Observational

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

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

NCT05427617CI-TRIAL-00059228ACTDNAGLTcompletedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Circulating Tumor DNA	Breast Neoplasm	PROBABILISTIC	0.70
Gene Abnormality	—	UNRESOLVED	—
Metastatic Breast Cancer	Malignant Breast Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Case group	Drug	—	UNRESOLVED
Control group	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Control group
description
Control group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality.
interventionNames
1. Drug: Control group
label
Case group
description
Case group includes patients with druggable ctDNA abnormality.
interventionNames
1. Drug: Case group

Primary outcomes (2)

measure
Disease Control Rate (DCR)
timeFrame
From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment.
description
The total rate of CR+PR+SD after the completion of two cycles of late-line therapy.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.